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Clinical Trial Summary

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.


Clinical Trial Description

Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia. The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04749329
Study type Interventional
Source Azienda Sanitaria Locale Napoli 2 Nord
Contact Francesco Pizza, Md, PhD
Phone 3338275449
Email francesco_pizza@libero.it
Status Recruiting
Phase N/A
Start date August 1, 2024
Completion date August 1, 2024

See also
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