Status:
TERMINATED
Stoma Closure and Reinforcement Trial ll
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Becton, Dickinson and Company
Conditions:
Ileostomy - Stoma
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies wi...
Eligibility Criteria
Inclusion
- Age \> 18years.
- Patient is undergoing closure of loop ileostomy.
- Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy.
- Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery.
Exclusion
- Pre-existing systemic infection at the time of ileostomy takedown
- Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
- Previous abdominal hernia repair with mesh placement
- Concurrent surgical procedures in addition to closure of diverting loop ileostomy
- Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04916067
Start Date
December 1 2021
End Date
August 5 2024
Last Update
August 7 2024
Active Locations (1)
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1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756