NCT00907842

Hernia Prevention in Stomas

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Marc Schreinemacher · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Incisional Hernia
• Parastomal Hernia

Interventions

Type	Name	Description
DEVICE	Parietex Parastomal Mesh	mesh placed intraperitoneally around the stoma

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-02-01
• Completion: 2013-04-01
• First posted: 2009-05-25
• Last updated: 2013-04-08

Locations

1 site across 1 country: Netherlands