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

NCT ID: NCT04793009

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2021-02-28

Brief Summary

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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

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Conditions

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Hernia Colostomy Stoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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mesh group

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

funnel-shaped, intraperitoneal mesh placement

Intervention Type DEVICE

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

No interventions assigned to this group

Interventions

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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,)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* elecitve abdominoperineal resection

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walter Brunner

OTHER

Sponsor Role lead

Responsible Party

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Walter Brunner

Leitender Arzt kolorektale Chirurgie

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34265151 (View on PubMed)

Other Identifiers

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2021-00120

Identifier Type: OTHER

Identifier Source: secondary_id

CHIR2021WB

Identifier Type: -

Identifier Source: org_study_id

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