Peristomal Mesh for Prophylaxis of Parastomal Hernia

University of Oslo (UIO)

Status and phase: Completed; Phase 3

Conditions: Hernia

Treatments: Device: Mesh in permanent colostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00496418

S-07203a

Details and patient eligibility

About

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

Full description

Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.

Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Condition with indication for establishing a permanent end-colostomy.

Exclusion criteria

• Age under 18
• ASA score above 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Prophylactic stoma mesh

Experimental group

Description:

Mesh

Treatment:

Device: Mesh in permanent colostomy

No mesh prophylaxis

Active Comparator group

Description:

No mesh

Treatment:

Device: Mesh in permanent colostomy