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 Link

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.