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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908661

Enrollment

Registered

2009-05-27

Start date

2007-11-30

Completion date

2010-11-30

Last updated

2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parastomal Hernia

Keywords

Parastomal, hernia

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.

Interventions

DEVICELightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done	24 to 36 months after surgery

Secondary

Measure	Time frame
Measuring the quality of life using the SF-36	Preoperative and at the end of the study

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026