Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia

Not Applicable

Completed

• Conditions: Parastomal Hernia
• Interventions: Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

• Registration Number: NCT00908661
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

Detailed Description

Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.

Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-05-25
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients with permanent ostomy and 1 years of life expectancy
• Signed informed consent

Exclusion Criteria

• Allergy to the compounds of the mesh
• Rejection of the patient
• Rejection of the surgeon
• Field of emergency
• Life expectancy < 1 year
• Prior meshes in the surgical site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic mesh	Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh	All patients will have a permanent ostomy and a randomisation with prophylactic mesh

Primary Outcome Measures

Name	Time	Method
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done	24 to 36 months after surgery

Secondary Outcome Measures

Name	Time	Method
Measuring the quality of life using the SF-36	Preoperative and at the end of the study

Trial Locations

Locations (1)

Hospital Universitari Valldhebron Research Institute; 🇪🇸 Barcelona, Spain