Clinical trial NCT03683095: Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
Official title: Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lymph Leakage
Keywords: Lymphedema
Lymphovenous bypass
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18-70 years) with International Society of Lymphology Stage I-II lymphedema of the upper or lower extremity will be eligible for lymphovenous bypass.

Brief summary: BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Lymphovenous bypass - microsurgically anastomosing lymphatic channels and venules - has demonstrated promising results in the treatment of lymphedema. PURPOSE: The purpose of this study is to determine the efficacy of lymphovenous bypass in treating extremity lymphedema. METHODS: This is a prospective, single-arm, cohort study. Eligible patients between 18-70 years of age with extremity lymphedema will undergo lymphovenous bypass. The primary outcome measure will be extremity volume and the secondary outcome measure will be quality of life assessed by a validated assessment tool for lymphedema of the limbs (LYMQOL). Patients will be assessed preoperatively and at 3, 6, 9, and 12-months postoperatively. Each participant will serve as their own control.

Primary and secondary outcome measures will be assessed with paired t-tests. With a sample size of 9 patients we will have at least 80% power to reject the null hypothesis assuming an alpha level of 0.01. To further increase the power and to account for patients lost to follow-up the investigators will target a patient recruitment of 20.

The findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years.
2. Lymphedema of the upper or lower extremity.
3. International Society of Lymphology Stage I-II.

Exclusion Criteria:

1. Significant comorbidities that would preclude a patient from receiving a general anesthetic.

Primary outcomes:
measure: Extremity volume (v)
timeFrame: Assessed preoperatively and 12-months postoperatively.
Secondary outcomes:
measure: Quality of life assessment tool for lymphedema of the limbs (LYMQOL).
timeFrame: Assessed preoperatively and 12-months postoperatively.
Other outcomes:
measure: Number of episodes of cellulitis (n / year)
timeFrame: Patient estimate from the 12-months preoperatively compared with 12-months postoperatively.
measure: Need for ongoing compression therapy (yes / no)
timeFrame: Assessed preoperatively and 12-months postoperatively.
Locations:
Study officials:
affiliation: Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa
name: Moein Momtazi, MD
role: PRINCIPAL_INVESTIGATOR
References: