Clinical trial NCT03750461: Stoma Closure and Reinforcement Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Ileostomy - Stoma
Keywords: ileostomy
hernia
rectal cancer
colon cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Hitchcock Foundation
First posted: 2018-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Wound Occurrences
timeFrame: 30 days
measure: Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
timeFrame: 30 days
Secondary outcomes:
measure: Preliminary Efficacy Based on Number of Participants With Hernia Formation
timeFrame: 30 days, and then 6 months post procedure
measure: Bowel Function After Mesh Implantation
timeFrame: 2 years
measure: Quality of Life After Mesh Implantation
timeFrame: 2 years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Matthew Z Wilson, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References: