Peristomal Mesh for Prophylaxis of Parastomal Hernia

Hernia Clinical Trial

Official title:

Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496418
• Other study ID #: S-07203a
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: January 12, 2015
• Start date: July 2007
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age under 18

• ASA score above 3

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia

Intervention

Device:
• Mesh in permanent colostomy

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet HF	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parastomal hernia		at 3, 12, 24, 36 and 48 months	No
Secondary	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		4 years	No