Stoma Closure and Reinforcement Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/5/2019 |
| Start Date: | January 1, 2019 |
| End Date: | December 1, 2021 |
| Contact: | Matthew Z Wilson, MD, Msc |
| Email: | Matthew.z.wilson@hitchcock.org |
| Phone: | 603-650-8113 |
Stoma Closure and Reinforcement (SCAR) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer Patients
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.
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.
Inclusion Criteria:
1. Age > 18years
2. Patient is undergoing closure of loop ileostomy
3. Patient has a diagnosis of left sided colon or rectal cancer treated with resection
and diverting loop ileostomy
4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate
for surgery
Exclusion Criteria:
1. Pre-existing systemic infection at the time of ileostomy takedown
2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder
3. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy,
or prednisone >10mg/day)
4. Previous abdominal hernia repair with mesh placement
5. Concurrent procedures in addition to closure of diverting loop ileostomy
6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring
exploratory laparotomy for closure)
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Phone: 603-650-8113
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