Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
- Conditions
- LymphedemaPerioperative/Postoperative ComplicationsVulvar Cancer
- Registration Number
- NCT00028951
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Fibrin sealant may decrease lymphedema following surgery to remove lymph nodes in the groin by helping to seal the lymphatic vessels. It is not yet known if fibrin sealant is effective in decreasing lymphedema following surgery to remove lymph nodes.
PURPOSE: Randomized phase III trial to determine the effectiveness of fibrin sealant in reducing lymphedema following surgical removal of lymph nodes in patients who have cancer of the vulva.
- Detailed Description
OBJECTIVES:
* Compare the incidence of lymphedema of the lower extremity after lymph node dissection in patients with vulvar malignancies treated with fibrin sealant vs standard care.
* Compare the frequency of surgical complications in patients treated with fibrin sealant vs standard care.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: After radical vulvectomy or hemivulvectomy and lymphadenectomy, patients receive fibrin sealant to surgical site.
* Arm II: After surgery, patients receive standard care for closure of surgical site.
Lymphedema is assessed at time of drain removal, at week 6, and then at months 3 and 6.
Patients are followed at week 6 and at months 3 and 6.
PROJECTED ACCRUAL: A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
- Secondary Outcome Measures
Name Time Method Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Trial Locations
- Locations (49)
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Fox Chase-Temple Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
🇺🇸Burlington, Vermont, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
🇺🇸Camden, New Jersey, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Southeast Gynecologic Oncology Associates
🇺🇸Knoxville, Tennessee, United States
UPMC Cancer Center at Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States