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NCT04793009 Clinical Trial

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

Hernia Clinical Trial

Official title:
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04793009
Other study ID # CHIR2021WB
Secondary ID 2021-00120
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date February 28, 2021

Study information
Verified date March 2021
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date February 28, 2021
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• funnel-shaped, intraperitoneal mesh placement
Implantation of a prophylactic, 3D funnel-shaped, intraperitoneal, non-absorbable and synthetic mesh (Dyna Mesh IPST 2x15x15 cm™ and 3x16x16 cm™, FEG Textiltechnik, Aachen, Germany,)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Walter Brunner

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of parastomal hernia clinical or radiological diagnosed parastomal hernia initial operation until an avarage of 3 years
Secondary Reoperations due to parastomal hernia Reoperation due to problems caused by parastomal hernia initial operation until an avarage of 3 years
Secondary Mesh-associated complications any complications due to the mesh initial operation until an avarage of 3 years
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