Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer

Incisional Hernia Clinical Trial

— VRAM  

Official title:

Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647569
• Other study ID #: VRAM M-20070240
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: September 6, 2013
• Start date: April 2008
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.

Exclusion Criteria:

• Pre or perioperative knowledge of disseminated malignancy

• Unable to follow the control program

• Known allergy to pig

• Compromised immune defense

• Artificial heart valve or recent (< 3 months) implanted foreign body

• Age < 18 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Pelvic Cancer

Intervention

Procedure:
• Mesh repair
A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.
• Conventional facial closure
The abdominal facia is closed with with continuous running suture

Locations

Country	Name	City	State
Denmark	Surgical Research Unit, Department of Surgery P, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Cook Biotech Incorporated

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incisional hernia formation determined by CT scan 1 year postoperative		1 year postoperative	No
Secondary	postoperative morbidity		30 days postoperative	Yes