Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683095
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment
Lymph Leakage Procedure: Lymphovenous bypass

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Group/Cohort Intervention/treatment
Lymphovenous bypass
Patients with extremity lymphedema treated with lymphovenous bypass.
Procedure: Lymphovenous bypass

Lymphovenous bypass will be performed under general anesthetic. Indocyanine green lymphangiography will be performed by injecting indocyanine green into each finger / toe web of the lymphedematous limb and mapping the lymphatic system with the NOVADAQ SPY Fluorescence Imaging (Mississauga, Canada).

Subdermal dissection of lymphatics and venules will be carried out under a surgical microscope. Lymphatic vessels will be anastomosed to adjacent recipient venules to create the bypass between the lymphatic and the venous systems. In total, 1-5 anastomoses will be performed. This will require 1-5 incisions, each with a length of 2-3 cm.

Postoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required.

The surgery will be performed on an outpatient basis with no planned hospital stay.





Primary Outcome Measures :
  1. Extremity volume (v) [ Time Frame: Assessed preoperatively and 12-months postoperatively. ]
    Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.


Secondary Outcome Measures :
  1. Quality of life assessment tool for lymphedema of the limbs (LYMQOL). [ Time Frame: Assessed preoperatively and 12-months postoperatively. ]
    Quality of life assessment tool for lymphedema of the limbs.


Other Outcome Measures:
  1. Number of episodes of cellulitis (n / year) [ Time Frame: Patient estimate from the 12-months preoperatively compared with 12-months postoperatively. ]
    Number of episodes of cellulitis requiring antimicrobial therapy (n / year).

  2. Need for ongoing compression therapy (yes / no) [ Time Frame: Assessed preoperatively and 12-months postoperatively. ]
    Need for ongoing compression therapy as defined by the use of acute bandaging, compression garments, or manual compression therapy (yes / no).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683095


Contacts
Layout table for location contacts
Contact: Moein Momtazi, MD 613-737-8899 ext 73480 mmomtazi@toh.ca
Contact: Linden K Head, MD 613-805-4323 linden.head@gmail.com

Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Moein Momtazi, MD Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03683095     History of Changes
Other Study ID Numbers: 20180289-01H
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Lymphedema
Lymphovenous bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases