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

March 8, 2021 updated by: Walter Brunner

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving elective abdominoperineal resection between January 2013 and December 2018 at the Cantonal Hospital of St. Gallen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of parastomal hernia
Time Frame: initial operation until an avarage of 3 years
clinical or radiological diagnosed parastomal hernia
initial operation until an avarage of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperations due to parastomal hernia
Time Frame: initial operation until an avarage of 3 years
Reoperation due to problems caused by parastomal hernia
initial operation until an avarage of 3 years
Mesh-associated complications
Time Frame: initial operation until an avarage of 3 years
any complications due to the mesh
initial operation until an avarage of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Brunner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIR2021WB
  • 2021-00120 (Other Identifier: BASEC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be made available to researchers whose proposed use of the data has been approved.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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