NCT04793009

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

6 years

First QC Date

March 1, 2021

Last Update Submit

March 8, 2021

Conditions

HerniaColostomy Stoma

Outcome Measures

Primary Outcomes (1)

  • Occurrence of parastomal hernia

    clinical or radiological diagnosed parastomal hernia

    initial operation until an avarage of 3 years

Secondary Outcomes (2)

  • Reoperations due to parastomal hernia

    initial operation until an avarage of 3 years

  • Mesh-associated complications

    initial operation until an avarage of 3 years

Study Arms (2)

mesh group

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

Device: funnel-shaped, intraperitoneal mesh placement

no-mesh group

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

Interventions

funnel-shaped, intraperitoneal mesh placementDEVICE

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,)

mesh group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • elecitve abdominoperineal resection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ammann Y, Widmann B, Sparn M, Warschkow R, Weitzendorfer M, Brunner W. Prophylactic funnel mesh to prevent parastomal hernia in permanent end colostomy: A retrospective cohort study. Colorectal Dis. 2021 Oct;23(10):2627-2636. doi: 10.1111/codi.15817. Epub 2021 Sep 4.

    PMID: 34265151DERIVED

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Leitender Arzt kolorektale Chirurgie

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 11, 2021

Study Start

January 1, 2013

Primary Completion

December 31, 2018

Study Completion

February 28, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03