Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer - Full Text View

Sponsors and Collaborators:	University of Aarhus Cook Biotech Incorporated
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00647569

Purpose

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.

Condition	Intervention	Phase
Incisional Hernia Pelvic Cancer	Procedure: Mesh repair Procedure: Conventional facial closure	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hernia Surgery

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

incisional hernia formation determined by CT scan 1 year postoperative [ Time Frame: 1 year postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

postoperative morbidity [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental No previous major abdominal surgery	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. Procedure: Conventional facial closure The abdominal facia is closed with with continuous running suture
B: Experimental Previous major abdominal surgery	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. Procedure: Conventional facial closure The abdominal facia is closed with with continuous running suture

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647569

Contacts

Contact: Peter Christensen, M.D., Ph.D	+45 8949 7527	piz@webspeed.dk
Contact: Søren Laurberg, D.M.Sci	+45 8949 7715	OVL07SL@as.aaa.dk

Locations

Denmark
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital	Recruiting
Aarhus, Denmark, 8000
Contact: Peter Christensen +45 8949 7527 piz@webspeed.dk
Principal Investigator: Peter Christensen

Sponsors and Collaborators

University of Aarhus

Cook Biotech Incorporated

Investigators

Principal Investigator:

Peter Christensen, M.D., Ph.d

Department of Surgery P, Aarhus University Hospital, Denmark

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Peter Christensen, M.D., Ph.D )
Study ID Numbers:	VRAM M-20070240
Study First Received:	March 26, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00647569 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

vertical rectus abdominis musculocutaneus flap
mesh repair
salvage surgery

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Ventral
Pelvic Neoplasms

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Neoplasms
Neoplasms by Site
Hernia

Hernia, Abdominal
Hernia, Ventral
Pelvic Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009