Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

Phase 3

Completed

• Conditions: Lymphedema; Perioperative/Postoperative Complications; Vulvar 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.

Study Timeline

• Study First Submitted: 2002-01-04
• Study Start: 2003-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-12
• Primary Completion: 2005-12
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

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)

Comprehensive Cancer Center at University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

MBCCOP - University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Evanston; 🇺🇸 Evanston, Illinois, United States

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