Surgical Techniques

Surgical Techniques

PEP Topic 
Lymphedema
Description 

A variety of surgical and microsurgical techniques have been examined for prevention or treatment of lymphedema in patients with cancer. Techniques include harvesting tissue from nonsurgical sites, such as lymph nodes and vascular structures, and transplanting to the area operated on for tumor removal. Techniques to attempt to preserve specific veins at the time of surgery and creation of lymphatic-venous anastomosis also have been used. Surgical interventions include use of different types of surgical closure.

Effectiveness Not Established

Systematic Review/Meta-Analysis

Abbas, S., & Seitz, M. (2009). Systematic review and meta-analysis of the used surgical techniques to reduce leg lymphedema following radical inguinal nodes dissection. Surgical Oncology, 20(2), 88–96.

doi: 10.1016/j.suronc.2009.11.003
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Purpose:

To assess the efficacy of available strategies to reduce the risk and severity of leg lymphedema

Search Strategy:

Databases searched were MEDLINE (from January 1966 to April 2009), EMBASE (from January 1980 to April 2009), and the Cochrane Colorectal Cancer Group Specialized Register (January 2009).

Search keywords were inguinal node dissection, lymphedema, malignant melanoma, squamous cell carcinoma, saphenous vein, prevention, and combinations of these words.

Studies were included in the review if they

  • Evaluated patients who underwent inguinal node dissection for metastatic malignant disease from the genitalia, lower trunk, or lower limbs.
  • Used a comparison group (control) derived from the same population of patients who suffered the same condition.
  • Included a cohort of patients with matching demographics, gender, comorbidities, and other forms of treatment, such as radiation therapy.
  • Used the same surgical technique for prevention of lymphedema and other complications.
  • Included a sufficient follow-up period to evaluate the development of chronic complications.
  • Lymphedema has been defined clearly based on limb girth measurements.

The authors did not list the exclusion criteria. However, in the results section, the authors mentioned that two studies were excluded from the meta-analysis because they did not focus on the effect of saphenous vein preservation.

Literature Evaluated:

Suitable studies were assessed using the Newcastle-Ottawa scale for evaluation of the quality of nonrandomized cohort studies. This scale uses a star system for evaluation of nonrandomized studies. The grading is based on three criteria: patient selection, comparability of study groups, and outcome assessment. The analysis included studies that scored 6 stars or higher and were considered suitable for inclusion in the meta-analysis. The total number of studies initially reviewed was 14. Of these, 12 were included in the report and 4 in the meta-analysis.

Meta-analysis was conducted with the studies that reported on saphenous vein preservation. The rest were individual reports and were not pooled. The primary outcome was the rates of leg lymphedema. Other outcomes, such as cellulitis, flap necrosis, lymphocele, the number of harvested nodes, and rate of cancer recurrence, were considered secondary endpoints. Studies deemed suitable according to the Newcastle-Ottawa scale were pooled, and the data was entered in ‘‘Metaview’’, which is used by the Cochrane methods for systematic reviews. All of the results were analyzed as dichotomous variables. Statistical heterogeneity in the results of the meta-analysis was assessed by graphical presentations of the confidence intervals (CI) on forest plots and by performing a χ2 test for heterogeneity, in which p = 0.1 was regarded as significant heterogeneity.

Data were analyzed using a random effect model and expressed in odds ratios and a Forest plot. Heterogeneity among the included studies was tested using the Cochrane Q test, with p values < 0.01 to ensure that odd ratios from separate studies were homogenously distributed. A funnel plot then was constructed to visually test for the presence of publication bias.

Sample Characteristics:

  • The total sample size included in the meta-analysis was 262.
  • Sample ranges across all studies in the meta-analysis was 10–139.
  • Sample characteristics of the studies in the meta-analysis were patients with vulval malignancies, inguinal lymphadenectomy, and saphenous vein preserved or sacrificed.

Results:

The search result defined few studies that reported results of saphenous vein sparing technique; some of those studies were found suitable for meta-analysis based on the Newcastle-Ottawa scale for nonrandomized studies. The meta-analysis showed significant reduction of lymphedema (odds ratio 0.24; 95% CI, 0.11–0.53) and other complications of inguinal node dissection. No randomized studies addressed this problem. Isolated studies reported on the benefits of other techniques, but none of them was suitable for meta-analysis.

Conclusions:

Meta-analysis of the reported studies on sparing the long saphenous vein in inguinal node dissection suggests a reduced rate of lymphedema and other postoperative complications.

Nursing Implications:

Other methods that may be beneficial are fascia preserving dissection, pedicledomental flap, and microsurgery. Sartorius transposition has not been shown to reduce the rate of complications. Randomized controlled trials are needed to prove the benefits of various technical modifications.

Carl, H.M., Walia, G., Bello, R., Clarke-Pearson, E., Hassanein, A.H., Cho, B., . . . Sacks, J.M. (2017). Systematic review of the surgical treatment of extremity lymphedema. Journal of Reconstructive Microsurgery. Advance online publication. 

doi: 10.1055/s-0037-1599100
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Purpose:

STUDY PURPOSE: To examine the results of various surgical treatment for lymphema

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: MEDLINE, EMBASE, Scopus, Web of Science, and Cochrane Collaboration from January 2000–May 2016
 
INCLUSION CRITERIA: Minimum sample of eight patients; study describing surgical treatment for extremity lymphedema
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: Not reported
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: MINORS scoring system was used. Highly valid studies were based on scores of 12 of 16 points or 19 of 24 points.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 69 studies met inclusion criteria.
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not provided
  • SAMPLE RANGE ACROSS STUDIES: Not provided

Phase of Care and Clinical Applications:

PHASE OF CARE: Not specified or not applicable

Results:

  • Five studies involving excisional procedures, including 76 patients reporting limb volume reduction ranging from 16%–52%; four of the five studies reported multiple complications from the procedures.
  • Four studies, including 105 patients with lower or upper extremity lymphedema reporting the effects of liposuction procedures; the weighted average percent of volume reduction was 96.63%.
  • Lymphatic reconstruction procedures reported a weighted average for limb reduction of 5.8%. Lymphaticovenous anastomosis results were reported in 12 studies.
  • Ten studies reported results from 185 patients who had tissue transfer procedures. For these, the weighted average limb reduction based on circumference was 39.5%.
  • Eight studies, including 135 patients reporting the use of multiple surgical approaches; the combinations of techniques were varied.
  • Studies varied regarding continued use of compression garments and physiotherapy postoperatively.
  • Based on the results of this review, the authors provided an algorithm for decision making in the application of various surgical techniques.

Conclusions:

The findings suggest that various surgical techniques can be effective to reduce limb volume; however, the research has several limitations. Relatively few studies examine each specific technique, and little evidence comparing these techniques to outcomes with other interventions known to be effective exists.

Limitations:

  • High heterogeneity
  • Low sample sizes
  • Varied methods of measuring lymphedema

Nursing Implications:

A variety of surgical techniques and microsurgical procedures are being evaluated for their effects on the development of lymphedema. Currently, limited evidence supports any particular procedure or technique. Nurses should be aware of any potential long-term side effects of such procedures as this information becomes available.

Cormier, J.N., Rourke, L., Crosby, M., Chang, D., & Armer, J. (2012). The surgical treatment of lymphedema: A systematic review of the contemporary literature (2004-2010). Annals of Surgical Oncology, 19(2), 642–651.

doi: 10.1245/s10434-011-2017-4
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Purpose:

To examine peer-reviewed literature evaluating the surgical treatment of lymphedema

Search Strategy:

  • Databases searched were MEDLINE, CINAHL, Cochrane Library, PapersFirst, ProceedingsFirst, Worldcat, PEDro, National Guidelines Clearing House, ACP Journal Club and Dare (2004–2010).
  • Search keywords were not stated.
  • Studies were included in the review if they were related to lymphedema and involved eight or more patients.
  • Studies were excluded if they were not refereed articles.

Literature Evaluated:

  • The total number of references retrieved was not stated.
  • Studies were evaluated using an adapted checklist using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) scale. 

Sample Characteristics:

  • The final number of studies was 19.
  • Sample range across all studies was 9–1,800, with larger samples in retrospective descriptive studies
  • Key sample characteristics were not provided.

Results:

Findings were grouped according to the type of procedure: excisional (8 studies, 4 involving liposuction), lymphatic reconstruction (8 studies of  lymphatic venous anastomosis [LVA]), and tissue transfer (4 studies involving lymph node transfer, stromal cell transplant, lymphatic tissue transplant, and lymph node transplant). Reduction in lymphedema volume was greatest after excisional procedures (91.1%). Lymphatic reconstruction was associated with 54.9% reduction, and tissue transfer with 47.6% reduction. Overall, surgical procedures did not appear to eliminate the need for compression therapy. Follow-up duration and methods of lymphedema measurement varied substantially across studies. Quality scores for studies ranged from 2–12 across all procedure types and tended to vary considerably within surgery type grouping as well. Studies were done in both upper and lower extremities, though most LVAs were done in lower extremities. The majority of studies did not comment on postoperative complications. Authors noted that a growing body of evidence supports the use of surgical procedures for prevention of lymphedema.

Conclusions:

Evidence related to the effectiveness of various surgical procedures for lymphedema is somewhat limited, and the ability to generalize findings also is limited given the wide variation in study quality, sample sizes, measurement methods, and lack of long-term follow up information. Surgical procedures have not been shown to eliminate the need for ongoing conventional therapies for lymphedema.

Limitations:

This review is limited by a lack of full information on search results, with consort type of flow charting, lack of information about disease types, and patient characteristics.

Nursing Implications:

Results of surgical procedures appear to show some promise for reducing lymphedema volumes. However, current evidence is too limited to generalize and more information is needed regarding postoperative complications or long-term results. Surgical intervention has not been shown to eliminate the need for ongoing conservative and conventional interventions as well.

Leung, N., Furniss, D., & Giele, H. (2015). Modern surgical management of breast cancer therapy related upper limb and breast lymphoedema. Maturitas, 80, 384–390. 

doi:10.1016/j.maturitas.2015.01.012
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Purpose:

STUDY PURPOSE: To consider the risks, benefits, and efficacy of current techniques in preventing or managing upper extremity lymphedema related to breast cancer surgery and to bring focus to more specific research gaps for additional investigation
 
TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: MEDLINE
 
KEYWORDS: Lymphatic vessels, lymphedema, and surgery (related to these)
 
INCLUSION CRITERIA: Published after 2000; only modern surgical techniques; prevention or treatment
 
EXCLUSION CRITERIA: Studies not meeting the criteria for inclusion

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 20,614
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A literature search of MEDLINE from its start to February 2014 was completed. The studies included had to be published after 2000 and either prevent or treat lymphedema secondary to breast cancer treatment. The studies' references also were reviewed for inclusion.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 16
  • TOTAL PATIENTS INCLUDED IN REVIEW = 305 
  • KEY SAMPLE CHARACTERISTICS: Breast cancer patients only; patients with and without lymphedema

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Palliative care 

Results:

The most useful procedure out of those reviewed was lymphatic vessel anastomosis. The least recommended was lymph node transfer because of conflicting data and potential complications. The remaining reviewed options would be effective based on individual cases and needs.

Conclusions:

  1. More research on lymphatic vessel anastomosis determining the ideal population and parameters for its use is needed.
  2. Better definitions of outcomes and a more specific focus for research and data interpretation are needed.
  3. Standards for the diagnosis and treatment of lymphedema must be improved to identify current and potential patients who may need interventions or prevention.

Limitations:

  • No noted method to evaluate the quality of the studies being reviewed

Nursing Implications:

The findings of this systematic review showed that initiatives to do primary research and data collection would be useful. This may be an area in which nurses can contribute.

Ozturk, C.N., Ozturk, C., Glasgow, M., Platek, M., Ashary, Z., Kuhn, J., . . . Gurunluoglu, R. (2016). Free vascularized lymph node transfer for treatment of lymphedema: A systematic evidence based review. Journal of Plastic, Reconstructive and Aesthetic Surgery, 69, 1234–1247. 

doi: 10.1016/j.bjps.2016.06.022
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Purpose:

STUDY PURPOSE: To review current research of free vascularized lymph node transfer (VLNT) for the treatment of lymphedema

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: PubMed, EMBASE, CENTRAL electronic databases
 
YEARS INCLUDED: 1980 to May 1, 2015
 
INCLUSION CRITERIA: English language; VNLT only; could be used on upper or lower extremity lymphedema; more than five participants in each study; the studies were living human participants; in addition, the reviewers read the study references.  
 
EXCLUSION CRITERIA: Cadaver and animal studies

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 831
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Four authors participated in the review and ranking of the articles selection. The American Society of Plastic Surgeons (ASPS) has a checklist of guidelines, which includes a rigorous process to eliminate bias in selection for bias in selection. Finally, the ASPS has a level of evidence scale, and rankings were applied to each of the studies.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 18
  • TOTAL PATIENTS INCLUDED IN REVIEW = 305 patients, 309 limbs and 316 flaps
  • SAMPLE RANGE ACROSS STUDIES: Participants aged 13–80 years, 195 upper limbs and 114 lower. Secondary lymphedema was the leading cause of LE. Limb size determination varied. The duration of lymphedema varied from 3 months to 26 years. The average duration of lymphedema was greater than 24 years. Postoperative follow-up ranged from 2 to 132 months. 
  • KEY SAMPLE CHARACTERISTICS: Level of evidence studies: 3 were level II, 13 were level III, and 2 were level IV. None of the studies were ranked I or high quality.

Phase of Care and Clinical Applications:

PHASE OF CARE: Pre- and postoperative VLNT
 
APPLICATIONS: Elder care

Results:

  • Outcomes varied because evaluation of reduction was not consistent across studies.  
  • Circumferential measurement reduction: Ninety-one percent showed postoperative improvement.  
  • Lymphangioscintigraphy/lymphangiography: Sixty percent improved flow with moderate to significant improvement.  
  • Patient satisfaction: All but seven patients stated improvement and surgery satisfaction.
 

Conclusions:

The findings suggest that the use of VLNT may be helpful in reducing lymphedema. Larger studies with standardized measurements are needed to create a stronger body of research to fully evaluate this surgical procedure.

Limitations:

  • Limited number of studies included
  • Low sample sizes
  • The need to evaluate same lymphedema types, primary versus secondary, radiation, and no radiation is needed.  
  • All lymphedemas are not the same.

Nursing Implications:

Limited evidence supports surgical interventions to manage lymphedema. However, the studies being conducted, although scant, do have potential, but outcomes vary presently.

Penha, T. R., Ijsbrandy, C., Hendrix, N. A., Heuts, E. M., Voogd, A. C., von Meyenfeldt, M. F., & van der Hulst, R. R. (2013). Microsurgical techniques for the treatment of breast cancer-related lymphedema: A systematic review. Journal of Reconstructive Microsurgery, 29(2), 99–106.

doi: 10.1055/s-0032-1329919
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Purpose:

To summarize available literature on lymphatic microsurgery for breast cancer-related lymphedema

Search Strategy:

  • Databases searched were PubMed and MEDLINE (2000–2012).
  • Search keywords were lymphedema, microsurgery, surgical treatment, breast cancer, lymph node transfer, lymphovenous anastomosis, and lymph vessel transplantation.
  • Studies were included in the review if they involved breast cancer treatment examining the effectiveness of microsurgical intervention.
  • Studies were excluded if they involved primary lymphedema, lower extremity lymphedema, or mixed upper and lower extremity lymphedema.

Literature Evaluated:

  • The total number of references retrieved were not reported.
  • The checklist from the American Society of Plastic Surgery for therapeutic studies was used for quality assessment.

Sample Characteristics:

  • The final number of studies included was 19 case reports involving a total of 191 patients.
  • The sample range across all studies was 6–127.
  • All patients had a breast cancer diagnosis.

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

  • Four retrospective case series (n = 52) reported results of composite tissue transfer. Findings were rate of reduction in circumference, reduction in pain, reduced incidence of cellulitis, and improvement in quantitative lymph flow.
  • Two studies (n = 139) reported on lymph vessel transplantation. Outcomes included volume reduction and a case of donor site edema.
  • Four prospective case series evaluated microsurgery. Findings from these studies were mixed. Studies differed in terms of including patients with early nonfibrotic lymphedema or chronic lymphedema. A number of significant methodological limitations in the evidence were reviewed. 
  • Derivative microsurgery was associated with relief of neuropathic pain in two studies for 50%–100% of patients. 
  • Three studies of inguinal lymph node transfer reported discontinuation of postoperative conservative therapy of variable rates for 3–24 months. Results were better with shorter duration of lymphedema. Minimal adverse effects were reported overall.

Conclusions:

Very limited evidence exists regarding the efficacy of microsurgical techniques for the prevention and management of upper extremity lymphedema in patients with breast cancer who had axillary lymph node excision. The best findings were seen with inguinal lymph node transfer. Consistent positive findings and minimal reported adverse effects were reported. However, high quality-evidence is lacking.

Limitations:

Findings are limited because of the low number of studies, small samples, and lack of high-quality research. Additionally, follow-up duration varied, and most studies did not report rates related to the ability to discontinue conservative management for lymphedema.

Nursing Implications:

Microsurgical techniques for the prevention of lymphedema are promising; however, further high-quality research studies with long-term follow-up are needed.

Research Evidence Summaries

Bertheuil, N., Sulpice, L., Levi Sandri, G.B., Lavoue, V., Watier, E., & Meunier, B. (2015). Inguinal lymphadenectomy for stage III melanoma: a comparative study of two surgical approaches at the onset of lymphoedema. European Journal of Surgical Oncology, 41, 215–219.

doi: 10.1016/j.ejso.2014.10.062
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Study Purpose:

To compare the difference in occurrences of lymphedema and other postoperative complications following two different surgical approaches for stage 3 melanoma

Intervention Characteristics/Basic Study Process:

Researchers divided patients into two groups, one that received vertical incisions, and another that received transverse incisions. Taking into account individual variables and any postoperative issues, patients were retrospectively studied for the presence of lymphedema.

Sample Characteristics:

  • N = 53  
  • AVERAGE AGE = 52.79 years
  • MALES: 45% (rounded up), FEMALES: 55% (rounded up)
  • KEY DISEASE CHARACTERISTICS: Histologic type of melanoma; Breslow's depth; Clark's level; ulceration and regression
  • OTHER KEY SAMPLE CHARACTERISTICS: The presence of lymphedema, personal characteristics (i.e., height, weight, age, sex, body mass index, smoking status), skin necrosis, wound separation or infection, and seromas were taken into account.

Setting:

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Centre Hospitalier Universitaire, Rennes, France

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care 

Study Design:

Retrospective chart review

Measurement Instruments/Methods:

  • Lymphedema was considered present or not present according to medical charts.
  • There was no specific description of how lymphedema was measured or graded.

Results:

No statistically significant difference was noted between the two groups regarding any variable or characteristics, including the primary lymphedema status.

Conclusions:

The difference in surgical approach didn't influence surgical outcomes, potential complications, or potential for chronic lymphedema.

Limitations:

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group) 
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
 

 

Nursing Implications:

This study did not have a direct effect on nursing practice other than to help inform nurses about the low potential for surgical approaches to have a negative effect on outcomes.

Buda, A., Ghelardi, A., Fruscio, R., Guelfi, F., La Manna, M., Dell'Orto, F., & Milani, R. (2016). The contribution of a collagen-fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: A double institution observational study. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 197, 156–158. 

doi: 10.1016/j.ejogrb.2015.12.005
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Study Purpose:

To describe the effects of using a collagen fibrin patch on complications after inguinofemoral lymphadenectomy for gynecologic cancer

Intervention Characteristics/Basic Study Process:

Outcomes in consecutive women who underwent groin dissection using the fibrin patch were compared to historical controls who did not use the patch. The same surgical teams performed the procedures. The patch used contained a collagen matrix coated with coagulation factors that cause adhesion between the patch and wound surfaces. Short-term postoperative results and long-term complications, such as cellulitis and late lymphedema, were compared between groups.

Sample Characteristics:

  • N = 49   
  • MEAN AGE = 74.3 years
  • AGE RANGE = 48–95 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Most had vulvar primary tumors.

Setting:

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Italy

Study Design:

Observational with historical control comparison

Measurement Instruments/Methods:

Method of lymphedema determination or measurement is not described.

Results:

In the control group, 24% developed late lymphedema, compared to 4% of patients in the group that did not use the patch. No significant differences were observed between groups in the proportion of those who had mono- or bilateral dissections or the number of lymph nodes removed, although the fibrin patch group had a slightly lower number of lymph nodes removed and fewer underwent adjuvant radiotherapy.

Conclusions:

The findings suggest that the use of the fibrin patch may be helpful to prevent some complications of lymphadenectomy; however, stronger research evidence is needed for evaluation.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

Nursing Implications:

Various surgical techniques are being examined for their effects on lymphedema-related outcomes after lymph node resections. Ongoing research is needed to determine the overall effectiveness of various techniques. Limited evidence exists for interventions to prevent and manage lower limb lymphedema.

Carlson, J.W., Kauderer, J., Walker, J.L., Gold, M.A., O'Malley, D., Tuller, E., . . . Gynecologic Oncology Group. (2008). A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: A Gynecologic Oncology Group Study. Gynecologic Oncology, 110(1), 76–82.

doi: 10.1016/j.ygyno.2008.03.005
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Study Purpose:

To test the hypothesis that patients who receive a vapor-heated (VH) fibrin sealant in the inguinal wound following inguinal lymphadenectomy in conjunction with treatment of a vulvar neoplasm would experience a 25% reduction in the incidence of grade 2 and 3 lymphedema of the lower extremity compared to control patients

Intervention Characteristics/Basic Study Process:

Patients were randomized to the investigational or control arm of the study. In the investigational arm (FS), VH fibrin sealant was applied to the inguinal wound base. In the control arm (SC), the closure of the wound was performed without application of the fibrin sealant. Patients were assessed prior to treatment and postoperatively at the time of drain removal, at six weeks, and at three and six months.

Sample Characteristics:

  • The study sample (N = 137) was comprised of female patients with a vulvar malignancy.
  • Patients were randomized to the FS arm (n = 70) or the SC arm (n = 67).
  • Median age in the FS arm was 61 years, with a range of 30–90 years; median age in the SC arm was 57 years, with a range of 33–87 years.
  • All patients were undergoing a radical vulvectomy or hemivulvectomy with either an ipsilateral or bilateral inguinal lymphadenectomy.

Setting:

The study was conducted at multiple Gynecologic Oncology Group member institutions across the United States.

Study Design:

The study used a randomized phase III trial design.

Measurement Instruments/Methods:

  • Circumference was measured to determine leg lymphedema.
  • Surgical complications were measured, including vulvar wound separation, inguinal wound separation, grading of infection or cellulitis, and grading of seroma or lymphocyst.
  • Duration of drain and drain output in the 24 hours prior to drain discontinuation also were evaluated.

Results:

The incidence of grade 2 and 3 lymphedema was 67% in the SC arm and 60% in the FS arm (p = 0.4779). The incidence of lymphedema was strongly associated with inguinal infection (p = 0.0165). No statistically significant difference was found in duration of drains or drain output or incidence of inguinal infections, wound breakdowns, or seromas. The FS arm experienced an increased incidence of vulvar infections (p = 0.0098).

Conclusions:

VH fibrin sealant in inguinal lymphadenectomies does not reduce leg lymphedema and may increase the risk for complications in the vulvar wound.

Limitations:

  • The sample size in each group was small, with less than 100 participants.
  • Follow-up for circumferential measurement occurred only through six months.
  • The protocol prescribed 10–15 lb of pressure over the wound bed after the VH fibrin sealant had been applied, but the exact location and amount of pressure over the wound was not monitored.

Nursing Implications:

Future trials should be designed to evaluate surgical techniques and postoperative care that would decrease wound breakdowns and complications while monitoring for variables that may be related to increased incidence of swelling or lymphedema in patients with vulvar cancer.

Chen, R., Mu, L., Zhang, H., Xin, M., Luan, J., Mu, D., . . . Becker, C. (2014). Simultaneous breast reconstruction and treatment of breast cancer–related upper arm lymphedema with lymphatic lower abdominal flap. Annals of Plastic Surgery, 73, S12–S17. 

doi: 10.1097/SAP.0000000000000322
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Study Purpose:

To introduce key points relating to lower abdominal flap transplantation with vascularized lymph nodes, and to evaluate the effects of breast restoration or reconstruction and lymphatic transplantation to treat upper-arm lymphedema after breast cancer surgery

Intervention Characteristics/Basic Study Process:

Ten patients were recruited with postoperative, breast cancer-related lymphedema. Preoperatively, isotope radiography was used to determine lymphatic return obstruction. Patients were operated on in a standing position. A modified deep inferior epigastric perforator artery (DIEP) or microsurgical transverse abdominal myocutaneous island (TRAM) flap was accompanied by lymphatic tissue. The scar contracture of the axilla was relaxed and patients received abdominal transplantation of the lower abdominal flap with vascularized lymph node. Postoperatively, elastic bandages were applied for one year. Follow-up appointments occurred at one, three, six, and 12 months. The measurement indexes that were used included mid- and upper-arm circumference, clinical symptoms, and lymphoscintigraphy.

Sample Characteristics:

  • N = 10  
  • AGE RANGE = 36–50 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients had lymphedema for three to five years.

Setting:

  • SETTING TYPE: Inpatient    
  • LOCATION: Beijing, China

Study Design:

Controlled clinical trial

Measurement Instruments/Methods:

  • Isotope radiography
  • Multidetector-commuted tomography
  • Mid- and upper-arm circumference measurement
  • Clinical symptoms
  • Lymphoscintigraphy

Results:

All of the flaps worked. One patient experienced delayed wound healing. There was no obvious improvement in lymphedema in one patient. Seven patients saw improvements in lymphedema clinical symptoms and mean limb perimeter. One patient recovered. The mean reduction was 2.122 cm (SD = 2.331). Limb volume decrease was statistically significant between preoperative and postoperative measures (p < .05).

Conclusions:

Abdominal flap transplantation with vascularized lymph nodes and breast reconstruction, paired with treatment to upper-arm lymphedema and the use of elastic bandages as adjuvant treatment, is effective in restoring breast configuration and function.

Limitations:

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Other limitations/explanation: Inconsistent study results, lack of standardized surgical technique, and short follow-up.

Nursing Implications:

This procedure may be effective for treating some women with breast cancer-related lymphedema, and it can guide future research on effective lymphedema therapy and postoperative monitoring.

Gennaro, M., Maccauro, M., Sigari, C., Casalini, P., Bedodi, L., Conti, A. R., . . . Bombardieri, E. (2013). Selective axillary dissection after axillary reverse mapping to prevent breast cancer–related lymphoedema. European Journal of Surgical Oncology, 39, 1341–1345.

doi: 10.1016/j.ejso.2013.09.022
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Study Purpose:

To assess the occurrence of breast cancer–related lymphedema (BCRL) and the feasibility of selective axillary dissection (SAD) after axillary reverse mapping (ARM)

Intervention Characteristics/Basic Study Process:

ARM was performed on 60 patients undergoing SAD. Patients received follow-up after 6–36 months and were assessed for BCRL.

Sample Characteristics:

  • N = 60    
  • KEY DISEASE CHARACTERISTICS: Patients with axillary nodal involvement, diagnosed by positive sentinel lymph node biopsy or preoperative needle biopsy, scheduled for axillary lymph node dissection 
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients received three intradermal injections of Tc-labeled nanocolloid, and lymphoscintigraphy was performed one hour later. Operations were completed by the same surgeon, and SAD was completed up to Berg’s level III, with identification and preservation of the arm’s lymphatic hot spot when feasible.

Setting:

  • SITE: Single site 
  • SETTING TYPE: Inpatient 
  • LOCATION: Milan, Italy

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

The intervention group participated in the SAD intervention, and the control group usually had axillary lymph node dissection. 

Measurement Instruments/Methods:

  • T test
  • Chi-square
  • Fisher’s exact test

Results:

SAD was successful in 45 of 60 patients. Four of 45 patients in the intervention group and five of 15 patients in the control group developed lymphedema (p = .072). 

Conclusions:

BCRL with SAD technique after median follow-up of 16 months had 33% the rate of lymphedema occurence than conventional ALND. SAD technique requires a separate surgery from sentinel lymph node biopsy. Authors concede there may be a learning curve to this technique, and further research is needed to determine appropriate patient selection.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Other limitations/explanation:  Relatively short follow-up to determine development of BCRL

Nursing Implications:

New surgical techniques may result in lowering patient morbidity but does not eliminate the possibility of patients developing BCRL. Education should continue to be provided to all patients regarding early identification of signs and symptoms of BCRL.

Granzow, J.W., Soderberg, J.M., Kaji, A.H., & Dauphine, C. (2014). An effective system of surgical treatment of lymphedema. Annals of Surgical Oncology, 21, 1189–1194. 

doi: 10.1245/s10434-014-3515-y
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Study Purpose:

To review the effectiveness and safety outcomes of patients selected to receive surgical procedure for lymphedema (LE) after a program of complete decongestive therapy (CDT)

Intervention Characteristics/Basic Study Process:

LE therapy consisted of manual lymph drainage, compression bandaging and garments, and vascularized lymph node transfer (VLNT), which was used for upper extremity LE by removing lymph nodes from the groin and transferring them to the affected axilla or along with a deep inferior epigastric perforator (DIEP) flap. Lymphaticovenous anastomosis (LVA) was preferred for lower extremity LE, which was completed by connecting lymphatics to nearby microscopic veins. Both VLNT and LVA are for LE with primarily fluid component. Suction-assisted protein lipectomy (SAPL) is used to treat the solid type of LE and requires continued compression after procedure.

Sample Characteristics:

  • N = 26
  • MEAN AGE = 53 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women with upper extremity LE secondary to breast cancer, congenital lower extremity LE, or lower extremity LE secondary to gynecologic cancer treatment

Setting:

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University of California, Los Angeles, United States

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care, palliative care

Study Design:

Retrospective chart review

Measurement Instruments/Methods:

  • Circumferential limb volume
  • Excel database
  • Paired T-tests for pre-/postoperative comparisons
  • Volume reduction for SAPL at 4 and 12 months after surgery
  • Change in compression garment use and lymphedema therapy necessary for VLNT and LVA
  • Change in the incidence of cellulitis in all cases

Results:

Good outcomes of volume reduction, decreased need for compression garments, and reduction of episodes of cellulitis were achieved for a small, selective group of patients who received one of three treatment procedures (VLNT, LVA, or SAPL coupled with CDT by a certified lymphedema therapist). The incidence of severe cellulitis decreased from 58% to 15% (p < 0.0001). Patients who underwent  VLNT reported wearing their compression garments significantly less (p = 0.009) and needing less lymphedema therapy (p = 0.009). LVA was associated with a significant reduction in lymphedema therapy (p = 0.008) and trended toward significance in garment reduction (0.07). 88% of patients who underwent either VLNT or LVA showed a postoperative improvement in lymphedema symptoms. For patients who underwent SAPL, those who had arm lymphedema showed an average of a 111% reduction of excess fluid volume and those who had leg lymphedema showed an average reduction of 86% 12 months post operatively.

Conclusions:

The retrospective chart review of 26 selected patients from one surgeon identifying phases of LE, earlier with fluid component swelling, using VLNT, LVA, or SAPL showed positive results in regard to volume reduction, decreased infection episodes, and decreased garment/CDT requirements.

Limitations:

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Selective outcomes reporting
  • Key sample group differences that could influence results
  • Intervention expensive, impractical, or training needs

Nursing Implications:

CDT performed by a certified therapist is still needed for patients with lymphedema. This study identifies the surgical outcomes for selective patients, but it does not identify the specific inclusion or exclusion criteria for the surgical interventions. The average body-mass index for patients receiving one of the three interventions was 27.5. The relatively short interval of follow-up did not identify if the surgical interventions will continue to have the desired effects long-term. Financial reimbursement and payment issues were not addressed. The results may not be reproducible across all healthcare settings.

Hou, C., Wu, X., & Jin, X. (2008). Autologous bone marrow stromal cells transplantation for the treatment of secondary arm lymphedema: A prospective controlled study in patients with breast cancer related lymphedema. Japanese Journal of Clinical Oncology, 38(10), 670–674.

doi: 10.1093/jjco/hyn090
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Study Purpose:

To determine the short- and long-term effects of bone marrow stromal cells (BMSC) transplantation for breast cancer-related lymphedema and to compare and contrast BMSC transplantation with complex decongestive physiotherapy

Intervention Characteristics/Basic Study Process:

Patients in the complex decongestive physiotherapy group underwent manual lymphatic drainage, compression therapy, remedial exercises for arm and shoulder, and deep breathing to promote venous and lymphatic flow. Patients in the BMSC transplant group underwent bone marrow aspiration from the iliac crest, were admitted, and underwent brachial plexus or general anesthesia with range of transplantation being around the axilla, chest wall, and upper arm of the affected extremity. After the intensive phase, all patients were measured for and wore custom garment during waking hours. Patients were interviewed via telephone at 3 months and 12 months after treatment.

Sample Characteristics:

  • The study sample (N = 50) was comprised of the control group (n = 35) and the intervention group (n = 15).
  • Patients on an in-patient unit were enrolled and followed for one year.
  • All patients had were female and had underwent breast cancer surgery without radiation five years earlier.

Setting:

The study took place in a single site in China.

Study Design:

The study used a controlled trial design.

Measurement Instruments/Methods:

  • Pain was assessed on numerical scale from 0–5.
  • Volume measurements were performed according to Kuhnke’s Disk Model, measuring the circumferences of the arms at 4 cm intervals beginning at the wrist and ending at the shoulder.
  • The volume of edema was calculated as the difference between the affected and unaffected arms; the percentage of edema in the arm was then calculated.
  • The percentage of change in the edema arm was calculated by the formula [(VT – VI)/ (VI –VN)] 100, where VT is the post-treatment volume of the edema arm, VI the initial volume of the edema arm, and VN the volume of the normal arm.

Results:

Both groups of patients experienced a reduction in pain and lymphedema volume. Patients in the BMSC transplant group had better long-term results. At three months (p = 0.0151) and at 12 months (p = 0.0001) patients in the BMSC group had significantly greater reduction in edema in the affected limb.

Conclusions:

Autologous BMSC to treat breast cancer-related upper-extremity lymphedema was effective in the study at one year.

Limitations:

  • The study size was small, with less than 100 participants.
  • Study cites need for lymphoscintigraphy pre- and post-treatment to evaluate formulation of new lymphatic vessels.
  • They study had no random assignment.

Nursing Implications:

The study adds evidence to the effectiveness of complex decongestive physiotherapy in this population, which requires compliance with therapy, education, and support for patients and families.

Maldonado, G.E., Perez, C.A., Covarrubias, E.E., Cabriales, S.A., Leyva, L.A., Perez, J.C., & Almaguer, D.G. (2011). Autologous stem cells for the treatment of post-mastectomy lymphedema: A pilot study. Cytotherapy, 13(10), 1249–1255.

doi: 10.3109/14653249.2011.594791
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Study Purpose:

To establish the efficacy of using autologous stem cells (ASC) for the treatment of lymphedema associated with axillary lymph node dissection, define the possible complications, and compare outcomes with compression sleeve therapy

Intervention Characteristics/Basic Study Process:

Twenty patients were randomly assigned to the ASC group or the control group. The ASC group received subcutaneously administered granulocyte-colony-stimulating factor (300 mg per day) for three days prior to the procedure. On procedure day, 100 ml bone marrow was harvested from east posterior iliac crest while the patient was under conscious sedation. The product was centrifuged and, under laminar flow hood, plasma was removed and transferred to sterile test tube. Cells were isolated, and CD34 cells were counted using a flow cytometer. A specimen for microbe and 0.5–1 ml of cell suspension containing 20% albumin and normal saline was administered by intramuscular injection at 30–50 sites of the affected limb, depth of 1 cm, with 25 g needle. Injection range included around the axillary and affected chest wall and part of the upper arm during the first four weeks. Use was discontinued for the following four weeks and then used again for another four weeks. Patients were not allowed to use any other modality of treatment for lymphedema, including manual lymph drainage, exercise drug therapy, or skin products. The control group was given a four-hour practice session on correct use of compression sleeve of 15–20 mmHg.

Sample Characteristics:

  • The study sample (N = 20) was comprised of female patients with unilateral lymphedema secondary to mastectomy and axillary node dissection.
  • Mean age of participants was 50–56 years.
  • All patients had not had active cancer in the past five years.
  • Patients were excluded from the study if they were older than 75 years, had hypercoagulable states, cardiovascular disease, or bilateral mastectomies.

 

Setting:

The study took place at the University Hospital of the School of Medicine of the Universidad Autonoma de Nuevo Leon in Mexico.

Phase of Care and Clinical Applications:

The study has clinical applicability for late effects and survivorship.

Study Design:

The pilot study randomly assigned 10 women to either the ASC group or control group.

Measurement Instruments/Methods:

  • Patient's weight was recorded.
  • Limb volume measurements were taken of bilateral upper extremities in four areas, calculating mean by summation.
  • Arm volume was determined by trunked cone principle were obtained weekly for 12 weeks.
  • Patients were evaluated for pain, sensory loss, and arm mobility.

Results:

After 12 weeks, the ASC group had decreased pain, improved sensitivity, and improved mobility as compared to the control group. Volume reductions were similar between the two groups, with the control group being more user dependent.

Conclusions:

The study does not provide sufficient evidence to determine potential efficacy of stem cell transplant to manage lymphedema.

Limitations:

  • The study had a small sample size, with less than 30 participants.
  • Sample characteristics present a risk of bias.
  • Measurement validity and reliability is questionable.
  • The findings are not generalizable.
  • The intervention is expensive, impractical, or requires training.

Nursing Implications:

It is important to be aware of studies being conducted. The study has limited practical value in the United States today, but as ASC becomes a more accepted and standard of care, awareness of the decreases in pain and increased sensitivity and mobility may be of benefit.

Miller, C.L., Specht, M.C., Skolny, M.N., Horick, N., Jammallo, L.S., O’Toole, J., Taghian, A.G. (2014). Risk of lymphedema after mastectomy: Potential benefit of applying ACOSOG Z0011 protocol to mastectomy patients. Breast Cancer Research and Treatment, 144, 71–77. 

doi: 10.1007/s10549-014-2856-3
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Study Purpose:

To evaluate the rate of lymphedema occurrence in patients who recieved a mastectomy and a sentinel lymph node biopsy (SLNB) with radiation therapy (RT) compared to an axillary lymph node dissection (ALND) with or without RT, with a secondary purpose to identify risk factors for development of lymphedema

Intervention Characteristics/Basic Study Process:

Mastectomies were categorized into four treatment groups: SLNB without RT, SLND with RT, ALND without RT, and ALND with RT. RT included the chest wall with or without supraclavicular or axillary radiation. Measurements were obtained pre- and postoperatively, during treatment for breast cancer, and at follow-up visits after the completion of breast cancer treatment.

Sample Characteristics:

  • N = 627  
  • MEDIAN AGE = 50 years (range = 22–85 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Individuals who underwent mastectomies after a diagnosis of primary breast cancer between September 2005 and February 2013.

Setting:

  • SITE: Single-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Massachusetts General Hospital in Boston, United States

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Multiple phases of care

Study Design:

Pre/post design with repeated measures

Measurement Instruments/Methods:

  • A perometer was used to measure arm volume.
  • Weight-adjusted arm volume change (WAC) was used to detect arm volume change in each arm individually.
  • Lymphedema was defined as a measurement of ≥ 10% WAC.

Results:

Of 664 mastectomies, 52% (343/664) were SLNB without RT, 5% (34/664) were SLNB with RT, 9% (58/664) were ALND without RT, and 34% (229/664) were ALND with RT. The two-year cumulative lymphedema incidence was 10% (95%, CI = 2.6%–34.4%) for SLNB with RT compared to 19.3% (95%, CI = 10.8%–33.1%) for ALND without RT and 30.1% (95%, CI = 23.7%–37.8%) for ALND with RT. The lowest cumulative incidence was 2.19% (95%, CI = .88%–5.40%) for SLNB without RT.
 
By multivariate analysis, factors significantly associated with increased lymphedema risk included RT (p = .0017), ALND (p = .0001), greater number of lymph nodes removed (p = .0006), no reconstruction (p = .0418), higher body mass index (p < .0001), and older age (p = .0021).

Conclusions:

Avoiding completion ALND and receiving SLNB with RT may decrease lymphedema risk in patients requiring a mastectomy. This study indicates that the application of the American College of Surgeons Oncology Group's Z0011 treatment protocol may reduce the risk of lymphedema for patients who receive a mastectomy.

Limitations:

  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Other limitations/explanation: The group that received SLNB without RT was small (n = 34). Less than half (44%) of patients who received SLNB without RT had a positive SLNB. This was a single-site study.

Nursing Implications:

The study provides nurses with information about SLNB with RT and how its use may decrease the risk of developing lymphedema compared to patients who recieve ALND. However, the nonrandomized, controlled trial design and the different sample sizes of each study group limit the ability to generalize this study's findings. Future randomized, controlled studies are warranted.

Morotti, M., Menada, M.V., Boccardo, F., Ferrero, S., Casabona, F., Villa, G., . . . Papadia, A. (2013). Lymphedema microsurgical preventive healing approach for primary prevention of lower limb lymphedema after inguinofemoral lymphadenectomy for vulvar cancer. International Journal of Gynecological Cancer, 23, 769–774.

doi: 10.1097/IGC.0b013e318287a8e8
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Study Purpose:

To describe the use of microsurgical lymphatic venous anastomosis (LVA) to prevent lower limb lymphedema (LLL) in patients with vulvar cancer undergoing inguinofemoral lymph node dissection (ILND)

Intervention Characteristics/Basic Study Process:

The intervention group underwent the LVA procedure. Before incision of the skin in the inguinal region, blue dye was injected in the thigh muscles to identify the lymphatic vessels draining the leg. Lymphatic venous anastomosis was performed by inserting the blue lymphatics coming from the lower limb into one of the collateral branches of the femoral vein (telescopic end-to-end anastomosis). For the intervention group, circumferential measurements were assessed at preoperation, at drain removal, at eight weeks and four months postsurgery, and during routinely follow-up examinations. A lymphoscintigraphy was performed one month postsurgery. For the control group, circumferential measurements were taken at routine cancer surveillance examinations. Lymphoscintigraphies were performed at variable intervals of time from the surgery.

Sample Characteristics:

  • N  = 15  
  • AGE RANGE = 54–87 years
  • MALES: 0%, FEMALES: 100% 
  • KEY DISEASE CHARACTERISTICS: Patients with histologically confirmed invasive carcinoma of the vulva, requiring either unilateral or bilateral ILND, entered the study from November 2009 to June 2011.
  • OTHER KEY SAMPLE CHARACTERISTICS: 1 mm or greater stromal invasion, stage IB–III (according to International Federation of Gynecology and Obstetrics classification), and performance status of less than 2 according to the World Health Organization.

Setting:

  • SITE: Single site 
  • SETTING TYPE: Not specified 
  • LOCATION: University of Genoa, Italy

Phase of Care and Clinical Applications:

  • PHASE OF CARE:  Mutliple phases of care

Study Design:

  • Quasi-experimental design

Measurement Instruments/Methods:

  • Circumferential measurement of the ankle, midcalf, and midthigh
  •  Lymphoscintigraphy: Transport index

Results:

In the study group, four patients underwent bilateral ILND, and four patients underwent unilateral ILND. Blue-dyed lymphatics and nodes were identified in all patients. It was possible to perform LVA in all the patients. The mean time required to perform a monolateral LVA was 23.1 minutes (SD = 3.6; range, 17–32 minutes). The mean follow-up was 16.7 months (SD = 6.2); there was only one case of grade 1 lymphedema of the right leg. Lymphoscintigraphic results showed total mean transport index were 9.08 and 14.54 in the study and the control groups, respectively (p = 0.092).

Conclusions:

This study shows, for the first time, the feasibility of LVA in patients with vulvar cancer undergoing ILND. Although no significant difference noticed in lymphoscintigraphy at one month postsurgery, a trend toward a smaller mean of transport index was noted in the study group. Future studies with larger samples sizes are needed.

Limitations:

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: Different follow-up schedule between the two study groups; short follow-up; single-site study

Nursing Implications:

The study provides nurses with updated information about potential feasibility and early clinical outcome of LVA in patients with vulvar cancer undergoing ILND. However, the small sample size, non-randomized, controlled trial design, as well as short follow-up do not allow the researchers to draw definitive conclusions on the effectiveness of LVA technique in this population. Future large, long-term follow-up randomized, controlled trials are warranted.

Nicoli, F., Constantinides, J., Ciudad, P., Sapountzis, S., Kiranantawat, K., Lazzeri, D., . . . Chen, H.C. (2015). Free lymph node flap transfer and laser-assisted liposuction: A combined technique for the treatment of moderate upper limb lymphedema. Lasers in Medical Science, 30, 1377–1385.

doi: 10.1007/s10103-015-1736-3
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Study Purpose:

To determine the effectiveness of laser liposuction in combination with a lymph node flap transfer on moderate upper limb lymphedema in patients with breast cancer

Intervention Characteristics/Basic Study Process:

Patients first received a lymph node flap transfer. The lymph node flap was placed in the wrist. Laser liposuction was scheduled one to three months following the flap procedure to debulk the affected limb. Measurements were taken preoperatively and at three and six months following the procedure.

Sample Characteristics:

  • N = 10
  • MEAN AGE = 54.6 years (SD = 9.3 years, range = 35–67 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related upper limb lymphedema (moderate)
  • OTHER KEY SAMPLE CHARACTERISTICS: Breast cancer survivors who received modified radical mastectomies, axillary lymphadenectomy, and chemoradiotherapy

Setting:

  • SITE: Single site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Plastic and Reconstructive Surgery Department of the China Medical University Hospital in Taichung, Taiwan

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care 

Study Design:

Prospective clinical study with pre- and post-test measures

Measurement Instruments/Methods:

  • Photography
  • Serial arm measurements 
  • DermaLab® Combo device (skin tonicity) 

Results:

Six months after treatment, patients showed a reduction in arm circumference (mean = 30.5 cm, SD = 1.6 cm), which was a 90% improvement from baseline measurements. In addition, forearm circumference was reduced (mean = 27.5 cm, SD = 2.4 cm). This was a 93% improvement from baseline measurements. There was a significant reduction in arm volume from pre- to post-treatment (p > 0.01).

Conclusions:

Combining laser liposuction with lymph node flap transfer is a novel procedure. In this study, the intervention appeared safe and reliable, and it was an effective way to significantly reduce limb volume in patients with breast cancer experiencing upper limb lymphedema.

Limitations:

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs

Nursing Implications:

Free lymph node flap transfer and laser-assisted liposuction is very new for lymphedema treatment. This study's results were confusing, and nurses should continue observing this method. The small sample size makes it difficult to determine the extent to which this intervention would be effective for the majority of patients with upper limb lymphedema.

Tausch, C., Baege, A., Dietrich, D., Vergin, I., Heuer, H., Heusler, R.H., & Rageth, C. (2013). Can axillary reverse mapping avoid lymphedema in node positive breast cancer patients? European Journal of Surgical Oncology, 39, 880–886.

doi: 10.1016/j.ejso.2013.05.009
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Study Purpose:

To report the experience with a new technique, axillary reverse mapping (ARM), in patients scheduled for axillary lymph node dissection (ALND) and to evaluate its usefulness for reducing the incidence of lymphedema

Intervention Characteristics/Basic Study Process:

For the intervention group, blue dye was injected subcutaneously along the intermuscular groove of the upper inner arm; radioisotope was injected subcutaneously in the interdigital webspace of the hand. All blue and radioactive lymph vessels and lymph nodes were recorded. Only unsuspicious ARM lymph nodes located in the lateral part of the axillary basin were preserved. All other level I and II axillary lymph nodes were removed. One follow-up was conducted at a median of 19 months.

 

Sample Characteristics:

  • N  = 143 
  • MEDIAN AGE = 58 years
  • AGE RANGE = 29–88 years
  • MALES: 2.1%, FEMALES: 97.9%
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer undergoing ALND

Setting:

  • SITE: Single site 
  • SETTING TYPE: Inpatient 
  • LOCATION: Brust-Zentrum Zurich, Switzerland

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Mutliple phases of care

Study Design:

  • Pre-post design

Measurement Instruments/Methods:

  • Arm volume measured using water replacement method via an arm volumeter

Results:

ARM was performed in 143 patients subsequently undergoing ALND. ARM lymph nodes were successfully identified in 112 patients (78%). In 55 patients, at least one ARM lymph node had to be removed. In 14 of these, tumor involvement was confirmed. In 71 patients, one or more ARM nodes were preserved. During a median follow-up time of 19 months, no axillary recurrence was noted. Thirty-five of 114 evaluated patients developed lymphedema. Preservation of ARM lymph nodes did not significantly decrease the incidence of lymphedema

Conclusions:

ARM is feasible for patients with node-positive breast cancer. However, the study found no evidence that it reduces the incidence of lymphedema.

Limitations:

  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: Single0site study, non-RCT design, no baseline arm volume measure, and borderline power of the sample size

Nursing Implications:

Larger studies with rigorous design are needed to evaluate whether preservation of clinically unsuspicious ARM nodes is oncologically safe and effective in preventing secondary lymphedema in patients with breast cancer.

Travis, E.C., Shugg, S., & McEwan, W.M. (2015). Lymph node grafting in the treatment of upper limb lymphoedema: A clinical trial. ANZ Journal of Surgery, 85, 631–635. 

doi: 10.1111/ans.13171
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Study Purpose:

To explore the safety and efficacy of simple lymph node grafting

Intervention Characteristics/Basic Study Process:

The lymph node grafting procedure was performed in a day-surgery setting with local anesthetic infiltration at the donor site (groin) and the two recipient sites (wrist and supratrochlear area). A small dose of intravenous ketamine or midazolam was given as sedation. The nodes were grafted into the superficial soft tissue of the affected limb. Subcuticular absorbable sutures were used to close the wounds. Patients did not use their regular compressive therapy for the first six weeks postoperatively so as not to compress the superficial vessels supplying the graft. Each patient received five days of oral flucloxacillin (250 mg every eight hours) as prophylaxis against opportunistic infection.

Sample Characteristics:

  • N = 10
  • AVERAGE GE = 64 years (range = 41–78 years)
  • MALES: 10%, FEMALES: 90%
  • KEY DISEASE CHARACTERISTICS: Lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: Eight patients (80%) had breast cancer-related lymphedema, one (10%) had melanoma as the primary malignancy, and one (10%) had metastatic squamous cell carcinoma requiring axillary dissection. The average duration of lymphedema was 3.5 years, and all patients had tried conservative management since onset. All 10 patients were using compressive bandaging on a daily basis prior to involvement in the study. Four patients (40%) had International Society of Lymphology (ISL) stage 3 lymphedema, and the remaining six patients (60%) had ISL stage 2 lymphedema. Nine (90%) patients reported a subjective improvement in their lymphedema. The patient who had no subjective or objective improvement had ISL stage 3 lymphedema that had been established for five years.

Setting:

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Central Health and Disability Ethics Committee, New Zealand

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care 
 

Study Design:

Prospective, interventional study with repeated measures at two, six, and 12 weeks

Measurement Instruments/Methods:

  • Total circumferential volume (TCV) measurements were taken at the ulnar styloid and in 10 cm increments up the arm with patients in a seated position with arms hanging by their sides.

Results:

Seven (70%) patients had an objective decrease in the TCV of the affected limb, giving an average decrease of 89.6 ml (SD = 136.5, 95% CI, -141.1−320.4). The volume difference between baseline and 12 weeks was not statistically significant with a T-test (p = 0.4249). 
 
One patient developed a minor seroma at the groin donor site, which was noted at the two-week follow-up appointment. There were no incidences of graft loss, fat necrosis, donor limb lymphedema, wound dehiscence, or infection during the study period.

Conclusions:

Lymph node grafting is was a safe procedure and should be investigated as an alternative to a microsurgical procedure as treatment for upper limb lymphedema.

Limitations:

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs

Nursing Implications:

Lymph node grafting needs to be investigated. Nurses should advise patients according to the current evidence.

Yamamoto, T., Yamamoto, N., Yamashita, M., Furuya, M., Hayashi, A., & Koshima, I. (2014). Efferent lymphatic vessel anastomosis: Supermicrosurgical efferent lymphatic vessel-to-venous anastomosis for the prophylactic treatment of subclinical lymphedema. Annals of Plastic Surgery. Advance online publication. 

doi: 10.1097/SAP.0000000000000381
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Study Purpose:

To determine the effectiveness of efferent lymphatic vessel anastomosis on subclinical lower extremity lymphedema and on the prevention of lower extremity lymphedema in patients with gynecologic cancer

Intervention Characteristics/Basic Study Process:

Fourteen patients with unilateral lower extremity subclinical lymphedema received the intervention of supermicrosurgical efferent lymphatic vesssel-to-vessel anastomosis under local anesthesia. Leg dermal backflow (LDB) was used to determine preoperative and postoperative lymphedema volume. Patients were re-evaluated at a one-year interval.

Sample Characteristics:

  • N = 14  
  • AGE RANGE = 34–79 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All gynecologic cancers including ovarian, uterine, and cervical
  • OTHER KEY SAMPLE CHARACTERISTICS: No inguinal lymph node dissection; five had a history of pelvic radiation; six had a history of cellulitis 
 

Setting:

  • SITE: Not stated
  • SETTING TYPE: Outpatient    
  • LOCATION: Toranomon Hospital and University of Tokyo in Japan

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship

Study Design:

Pre- and post-test design

Measurement Instruments/Methods:

  • Lower Extremity Lymphedema (LEL) Index 
  • Leg Dermal Backflow (LDB) Staging
  • Student paired T test and two tests for statistic analyses

Results:

All 14 of the surgeries were without perioperative issues. Tension sensation in patients was decreased (significant finding), and a downstaging of LDB stage also was significant.

Conclusions:

This study was an important start for investigating improved surgical techniques to reduce and prevent the burden of lower extremity lymphedema. However, the sample size was too small, and other possible variables (such as history of certain chemotherapies or current treatments) were not discussed. It also was unclear how the participants were chosen or if they were randomized properly.

Limitations:

  • Small sample (< 30)
  • Risk of bias (no random assignment) 
  • Other limitations/explanation: Unclear whether patients continued to receive chemotherapy; body surface area unknown

Nursing Implications:

For nurses, having knowledge of these interventions is important to understanding how to educate patients on current and future options. Being up to date on current interventions and knowing if one's facility is current is important to each nurse's individual practice and professional growth. However, this is not an intervention that nurses can directly affect at this point.

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