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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00908661
First received: May 25, 2009
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Parastomal Hernia
Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measuring the quality of life using the SF-36 [ Time Frame: Preoperative and at the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: November 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prophylactic mesh
All patients will have a permanent ostomy and a randomisation with prophylactic mesh
Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Other Name: PROCEED mesh
No Intervention: without prophylactic mesh
All patients will have a permanent ostomy and a randomisation without prophylactic mesh

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908661

Locations
Spain
Hospital Universitari Valldhebron Research Institute
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MANUEL LOPEZ-CANO, MD,PhD, Hospital Universitari Vall d'Hebron. Department of Surgery
ClinicalTrials.gov Identifier: NCT00908661     History of Changes
Other Study ID Numbers: PR(AG)116/2006
Study First Received: May 25, 2009
Last Updated: March 14, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Parastomal, hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical
Cellulose, Oxidized
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014