NCT03578380

Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sykehuset Telemark · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.

Detailed description

This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).

Conditions

• Secondary Lymphedema
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery	Lymphovenous anastomosis
OTHER	Compression and drainage therapy	Treatment with compression stockings and manual drainage (massage therapy)

Timeline

• Start date: 2016-01-26
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-07-06
• Last updated: 2023-04-18

Locations

1 site across 1 country: Norway