Prevention of Parastomal Hernia by Primary Mesh Insertion

Status Terminated

Clinical Trial Summary

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00641342
Study type	Interventional
Source	University Hospital, Gentofte, Copenhagen
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	March 2007
Completion date	February 2015

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See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT06077318` - Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia
Completed	`NCT01380860` - Primary Prevention of Peristomial Hernias Via Parietal Prostheses	N/A
Completed	`NCT00908661` - Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia	N/A
Recruiting	`NCT04282473` - Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Completed	`NCT03792243` - Outcomes After Parastomal Hernia Repair
Recruiting	`NCT01955278` - Role of Prosthetic Mesh in Preventing Parastomal Hernias	Phase 3
Terminated	`NCT04966065` - Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
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Recruiting	`NCT03667287` - Stoma Hernia Intraperitoneal Full-Thickness Skin	N/A
Completed	`NCT01722565` - Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection	Phase 4
Completed	`NCT02368873` - the Use of a IPOM Mesh for Prevention of Parastomal Hernia	N/A
Completed	`NCT00917995` - Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh	Phase 2/Phase 3
Completed	`NCT02233465` - Treating Parastomal Hernia With a Mesh	Phase 1/Phase 2
Completed	`NCT01484743` - Risk Factors for Morbidity After Parastomal Hernia Repair
Completed	`NCT00509054` - Prevention of Parastomal Hernia With a Mesh	Phase 4
Completed	`NCT04187235` - Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia