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

Primary Purpose

Incisional Hernia, Pelvic Cancer

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Mesh repair
Conventional facial closure
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia focused on measuring vertical rectus abdominis musculocutaneus flap, mesh repair, salvage surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

No previous major abdominal surgery

Previous major abdominal surgery

Outcomes

Primary Outcome Measures

incisional hernia formation determined by CT scan 1 year postoperative

Secondary Outcome Measures

postoperative morbidity

Full Information

First Posted
March 26, 2008
Last Updated
September 6, 2013
Sponsor
University of Aarhus
Collaborators
Cook Biotech Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00647569
Brief Title
Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Cook Biotech Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Pelvic Cancer
Keywords
vertical rectus abdominis musculocutaneus flap, mesh repair, salvage surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
No previous major abdominal surgery
Arm Title
B
Arm Type
Experimental
Arm Description
Previous major abdominal surgery
Intervention Type
Procedure
Intervention Name(s)
Mesh repair
Other Intervention Name(s)
Surgisis Gold Hernia repair graft
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional facial closure
Intervention Description
The abdominal facia is closed with with continuous running suture
Primary Outcome Measure Information:
Title
incisional hernia formation determined by CT scan 1 year postoperative
Time Frame
1 year postoperative
Secondary Outcome Measure Information:
Title
postoperative morbidity
Time Frame
30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Christensen, M.D., Ph.d
Organizational Affiliation
Department of Surgery P, Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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