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

NCT ID: NCT00647569

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Incisional Hernia Pelvic Cancer

Keywords

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vertical rectus abdominis musculocutaneus flap mesh repair salvage surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

No previous major abdominal surgery

Group Type EXPERIMENTAL

Mesh repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

The abdominal facia is closed with with continuous running suture

B

Previous major abdominal surgery

Group Type EXPERIMENTAL

Mesh repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

The abdominal facia is closed with with continuous running suture

Interventions

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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.

Intervention Type PROCEDURE

Conventional facial closure

The abdominal facia is closed with with continuous running suture

Intervention Type PROCEDURE

Other Intervention Names

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Surgisis Gold Hernia repair graft

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Biotech Incorporated

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Christensen, M.D., Ph.d

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery P, Aarhus University Hospital, Denmark

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VRAM M-20070240

Identifier Type: -

Identifier Source: org_study_id