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

Sponsor

Walter Brunner (Other)

Overall Status

Completed

CT.gov ID

NCT04793009

Collaborator

(none)

Enrollment

97.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hernia Colostomy Stoma	Device: funnel-shaped, intraperitoneal mesh placement

Study Design

Study Type:

Observational

Actual Enrollment :

76 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
mesh group patients undergoing abdominoperineal resection with end colostomy and implantation of a prophylactic, funnel-shaped, intraperitoneal mesh	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,)
no-mesh group patients undergoing abdominoperineal resection with end colostomy without implantation of a prophylactic, funnel-shaped, intraperitoneal mesh

Arm

Intervention/Treatment

mesh group

patients undergoing abdominoperineal resection with end colostomy and implantation of a prophylactic, funnel-shaped, intraperitoneal mesh

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,)

no-mesh group

patients undergoing abdominoperineal resection with end colostomy without implantation of a prophylactic, funnel-shaped, intraperitoneal mesh

Outcome Measures

Primary Outcome Measures

Occurrence of parastomal hernia [initial operation until an avarage of 3 years]
clinical or radiological diagnosed parastomal hernia

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

elecitve abdominoperineal resection

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Walter Brunner

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walter Brunner, Leitender Arzt kolorektale Chirurgie, Cantonal Hospital of St. Gallen

ClinicalTrials.gov Identifier:

NCT04793009

Other Study ID Numbers:

CHIR2021WB
2021-00120

First Posted:

Mar 11, 2021

Last Update Posted:

Mar 11, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hernia

Study Results

No Results Posted as of Mar 11, 2021