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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
Time Frame: 30 days
The incidence of wound occurrences (defined as superficial surgical site infection \[s-SSI\], deep surgical site infection \[d-SSI\], organ space surgical site infection \[O-SSI\], dehiscence, and seroma formation) at 30days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be compared to historical controls.
Number of Participants With Wound Occurrences
Time Frame: 30 days
Incidence of wound occurrences (defined as superficial surgical site infection \[s-SSI\], deep surgical site infection \[d-SSI\], organ space surgical site infection \[O-SSI\], dehiscence, and seroma formation) at 30 days, with particular attention to wound occurrences requiring procedural intervention, including but not limited to, operative debridement, radiographically guided drain placement, or excision of the mesh will be assessed.
Secondary Outcomes
- Preliminary Efficacy Based on Number of Participants With Hernia Formation(30 days, and then 6 months post procedure)
- Bowel Function After Mesh Implantation(2 years)
- Quality of Life After Mesh Implantation(2 years)
Investigators
Matthew Z. Wilson
Assistant Professor of Surgery
Dartmouth-Hitchcock Medical Center