Hernia Prevention in Stomas

Incisional Hernia Clinical Trial

Official title: Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

Status Completed

Clinical Trial Summary

Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.

Clinical Trial Description

The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Parastomal Hernia

• NCT number: NCT00907842
• Study type: Interventional
• Source: Academisch Ziekenhuis Maastricht
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Completion date: April 2013