Hernia Prevention in Stomas

Not Applicable

Completed

• Conditions: Incisional Hernia; Parastomal Hernia
• Interventions: Device: Parietex Parastomal Mesh

• Registration Number: NCT00907842
• Lead Sponsor: Marc Schreinemacher

Brief 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.

Study Timeline

• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Study Start: 2010-04
• Primary Completion: 2013-02
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult patients with a life expectancy of at least one year
• Temporary stoma formation
• Signed informed consent
• Elective surgery
• Clean-contaminated abdomen

Exclusion Criteria

• American Society of Anaesthesiologists (ASA) score IV or above
• Incapacitated adult or no signed informed consent
• Emergency procedure
• Contaminated or infected abdomen
• Residual intraperitoneal mesh
• Already injured part of the abdominal wall where the stoma will be sited
• Contraindication to laparoscopy
• Longterm use of corticosteroids and other immunosuppressive agents
• Current antibiotic therapy
• One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesh placement	Parietex Parastomal Mesh	-

Primary Outcome Measures

Name	Time	Method
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)	one year after placement
incisional herniation at the old stoma wound	two years

Secondary Outcome Measures

Name	Time	Method
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)	two years after placement

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands