Prevention of Parastomal Hernia by Primary Mesh Insertion

University Hospital, Gentofte, Copenhagen

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Parastomal Hernia

Treatments

Device: onlay mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT00641342

PMPC

Details and patient eligibility

About

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

Enrollment

198 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion criteria

ASA > 3
Acute surgery
Known immune deficiency
Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
Pregnancy
Known inflammatory bowel disease
Lack of written informed consent