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

University of Aarhus

Status and phase: Completed; Phase 3

Conditions: Pelvic Cancer; Incisional Hernia

Treatments: Procedure: Conventional facial closure; Procedure: Mesh repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00647569

VRAM M-20070240

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

A

Experimental group

Description:

No previous major abdominal surgery

Treatment:

Procedure: Mesh repair

Procedure: Conventional facial closure

B

Experimental group

Description:

Previous major abdominal surgery

Treatment:

Procedure: Mesh repair

Procedure: Conventional facial closure