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Completed

NCT Number: NCT00908661

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

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.

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Key information

Conditions

Parastomal Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Valldhebron Research Institute

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Device

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Other names: PROCEED mesh

Primary outcomes

  1. 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

  1. Measuring the quality of life using the SF-36

    Time frame: Preoperative and at the end of the study

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 27, 2009
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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