Use of a Mesh to Prevent Parastomal Hernia

Corporacion Parc Tauli

Status: Completed

Conditions: Parastomal Hernia

Treatments: Device: Mesh (Ultrapro ®); Procedure: Conventional sigmoid end colostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00691860

CSPT-SerraA-01

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

1

Experimental group

Description:

Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®

Treatment:

Procedure: Conventional sigmoid end colostomy

Device: Mesh (Ultrapro ®)

2

Other group

Description:

Patients receiving conventional sigmoid end colostomy, without mesh

Treatment:

Procedure: Conventional sigmoid end colostomy