Status:
COMPLETED
Hernia Prevention in Stomas
Lead Sponsor:
Marc Schreinemacher
Conditions:
Incisional Hernia
Parastomal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 a...
Eligibility Criteria
Inclusion
- Adult patients with a life expectancy of at least one year
- Temporary stoma formation
- Signed informed consent
- Elective surgery
- Clean-contaminated abdomen
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00907842
Start Date
April 1 2010
End Date
April 1 2013
Last Update
April 8 2013
Active Locations (1)
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1
Maastricht University Medical Centre
Maastricht, Netherlands, 6200 AZ