Status:
COMPLETED
Stoma Closure and Reinforcement Trial
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Hitchcock Foundation
Conditions:
Colon Cancer
Rectal Cancer
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 left sided colon or rectal cancer 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
- On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone \>10mg/day)
- Previous abdominal hernia repair with mesh placement
- Concurrent 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 :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03750461
Start Date
January 1 2019
End Date
February 1 2023
Last Update
February 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756