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

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

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Key information

Conditions

Hernia Colostomy Stoma Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

elecitve abdominoperineal resection

Exclusion criteria

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

Treatment and study plan

funnel-shaped, intraperitoneal mesh placement

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,)

Primary outcomes

Occurrence of parastomal hernia

Time frame: initial operation until an avarage of 3 years

clinical or radiological diagnosed parastomal hernia

Secondary outcomes

Reoperations due to parastomal hernia

Time frame: initial operation until an avarage of 3 years

Reoperation due to problems caused by parastomal hernia
Mesh-associated complications

Time frame: initial operation until an avarage of 3 years

any complications due to the mesh

Sponsors and collaborators

Lead sponsor

Walter Brunner

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2021
First posted: Mar 11, 2021
Registry last updated: Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed