Use of a Mesh to Prevent Parastomal Hernia

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity

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Key information

Conditions

Parastomal Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
Aged over 18,
Charlson comorbidity index below 7
Elective surgery
Radical surgery

Exclusion criteria

Loop colostomies,
Emergency surgery,
Body mass index above 35 kg/sq.m.,
Palliative surgery,
Hepatic cirrhosis,
Severe COPD (requiring home oxygen treatment),
Corticoid treatment

Treatment and study plan

Mesh (Ultrapro ®)

Device

In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy

Other names: Ultrapro ®

Conventional sigmoid end colostomy

Procedure

Patients receiving conventional sigmoid end colostomy, without mesh

Primary outcomes

the reduction in the incidence of Parastomal Hernia after the mesh placement

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: Jun 6, 2008
Registry last updated: Sep 15, 2015

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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Completed