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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Parastomal Hernia

Treatments: Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00908661

PR(AG)116/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Prophylactic mesh

Active Comparator group

Description:

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

Treatment:

Device: Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

without prophylactic mesh

No Intervention group

Description:

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