NCT00691860

Use of a Mesh to Prevent Parastomal Hernia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
DEVICE	Mesh (Ultrapro ®)	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
PROCEDURE	Conventional sigmoid end colostomy	Patients receiving conventional sigmoid end colostomy, without mesh

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-01-01
• Completion: 2008-02-01
• First posted: 2008-06-06
• Last updated: 2015-09-15