Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia - Full Text View

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:

MedlinePlus related topics: Hernia Ostomy

U.S. FDA Resources

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

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:

Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7.

Jänes A, Israelsson L, Cengiz Y. Preventing Parastomal Hernia with a Prosthetic Mesh: A 5-Year Follow-Up of a Randomized Study: Reply to Letter. World J Surg. 2009 Apr 19; [Epub ahead of print] No abstract available.

López-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

López-Cano M, Lozoya-Trujillo R, Quiroga S, Sánchez JL, Vallribera F, Martí M, Jiménez LM, Armengol-Carrasco M, Espín E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11.

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 May 23, 2013