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Clinical Trials/NCT00908661
NCT00908661CompletedNot Applicable

Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country36 target enrollmentStarted: November 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Prophylactic mesh

Active Comparator

All patients will have a permanent ostomy and a randomisation with prophylactic mesh

Intervention: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh (Device)

without prophylactic mesh

No Intervention

All patients will have a permanent ostomy and a randomisation without prophylactic mesh

Outcomes

Primary Outcomes

If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done

Time Frame: 24 to 36 months after surgery

Secondary Outcomes

  • Measuring the quality of life using the SF-36(Preoperative and at the end of the study)

Investigators

Study Sites (1)

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