Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-26 @ 5:36 PM
Study NCT ID:
NCT03683095
Status:
WITHDRAWN
Last Update Posted:
2022-09-22
First Post:
2018-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Insufficient resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2018-09-16', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of episodes of cellulitis (n / year)', 'timeFrame': 'Patient estimate from the 12-months preoperatively compared with 12-months postoperatively.', 'description': 'Number of episodes of cellulitis requiring antimicrobial therapy (n / year).'}, {'measure': 'Need for ongoing compression therapy (yes / no)', 'timeFrame': 'Assessed preoperatively and 12-months postoperatively.', 'description': 'Need for ongoing compression therapy as defined by the use of acute bandaging, compression garments, or manual compression therapy (yes / no).'}], 'primaryOutcomes': [{'measure': 'Extremity volume (v)', 'timeFrame': 'Assessed preoperatively and 12-months postoperatively.', 'description': 'Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment tool for lymphedema of the limbs (LYMQOL).', 'timeFrame': 'Assessed preoperatively and 12-months postoperatively.', 'description': 'Quality of life assessment tool for lymphedema of the limbs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphedema', 'Lymphovenous bypass'], 'conditions': ['Lymph Leakage']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary 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.\n\nThe findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-70 years.\n2. Lymphedema of the upper or lower extremity.\n3. International Society of Lymphology Stage I-II.\n\nExclusion Criteria:\n\n1\\. Significant comorbidities that would preclude a patient from receiving a general anesthetic.'}, 'identificationModule': {'nctId': 'NCT03683095', 'briefTitle': 'Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema', 'orgStudyIdInfo': {'id': '20180289-01H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lymphovenous bypass', 'description': 'Patients with extremity lymphedema treated with lymphovenous bypass.', 'interventionNames': ['Procedure: Lymphovenous bypass']}], 'interventions': [{'name': 'Lymphovenous bypass', 'type': 'PROCEDURE', 'description': '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).\n\nSubdermal 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.\n\nPostoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required.\n\nThe surgery will be performed on an outpatient basis with no planned hospital stay.', 'armGroupLabels': ['Lymphovenous bypass']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Moein Momtazi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}