Clinical trial NCT04916067: Stoma Closure and Reinforcement Trial ll
Official title: Stoma Closure and Reinforcement (SCAR)-II Trial: A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy - Stoma
Inflammatory Bowel Diseases
Keywords: ileostomy
hernia
inflammatory bowel disease
IBD
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Becton, Dickinson and Company
First posted: 2021-06-07
Enrollment: 7
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 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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18years.
2. Patient is undergoing closure of loop ileostomy.
3. Patient has a diagnosis of Inflammatory bowel disease 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. Previous abdominal hernia repair with mesh placement
4. Concurrent surgical procedures in addition to closure of diverting loop ileostomy
5. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)

Primary outcomes:
measure: Incidence of wound occurrences
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of hernia formation
timeFrame: 30 days, 6 months
measure: Quality of Life after mesh implantation
timeFrame: 30 days, 6 months
measure: Bowel Function after mesh implantation
timeFrame: 30 days, 6 months
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:
citation: Goldwag JL, Wilson LR, Ivatury SJ, Pauli EM, Tsapakos MJ, Wilson MZ. Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial. Contemp Clin Trials Commun. 2020 Jun 9;19:100582. doi: 10.1016/j.conctc.2020.100582. eCollection 2020 Sep.