Stoma Closure and Reinforcement Trial ll
Stopped early · Not applicable
Conditions studied: Ileostomy - Stoma, Inflammatory Bowel Diseases
In brief
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 will reduce the incidence of hernia formation. In this trial, the investigator will pilot a novel technique of monofilament bioresorbable mesh reinforcement of the abdominal wall defects that remain after closure of an ileostomy to evaluate for safety and begin to evaluate the effectiveness compared to standard techniques.
Key facts
- Study ID
- NCT04916067
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 8
- Starts
- 2021-12-01
- Expected to finish
- 2024-08-05
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Full record on ClinicalTrials.gov
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