Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection

Completed

• Conditions: Colostomy Stoma; Hernia
• Interventions: Device: funnel-shaped, intraperitoneal mesh placement

• Registration Number: NCT04793009
• Lead Sponsor: Walter Brunner

Brief Summary

This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2021-02-28
• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• elecitve abdominoperineal resection

Exclusion Criteria

• rejection of a retrospective data Analysis
• age under 18 years
• meshes other than the funnel-shaped mesh

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mesh group	funnel-shaped, intraperitoneal mesh placement	patients undergoing abdominoperineal resection with end colostomy and implantation of a prophylactic, funnel-shaped, intraperitoneal mesh

Primary Outcome Measures

Name	Time	Method
Occurrence of parastomal hernia	initial operation until an avarage of 3 years	clinical or radiological diagnosed parastomal hernia

Secondary Outcome Measures

Name	Time	Method
Reoperations due to parastomal hernia	initial operation until an avarage of 3 years	Reoperation due to problems caused by parastomal hernia
Mesh-associated complications	initial operation until an avarage of 3 years	any complications due to the mesh