Stoma Closure and Reinforcement Trial (SCAR)
Status
Conditions
Treatments
Details and patient eligibility
About
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 large pore monofilament polypropylene 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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