Stoma Closure and Reinforcement Trial ll

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ileostomy - Stoma, Inflammatory Bowel Diseases

Intervention / Treatment
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* Device: Mesh Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18years. Patient is undergoing closure of loop ileostomy. Patient has a diagnosis of Inflammatory bowel disease 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 Previous abdominal hernia repair with mesh placement Concurrent surgical 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall | Device: Mesh Implantation<br>* Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound occurrences | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hernia formation | The incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and at 6 months from the date of ileostomy closure. | 30 days, 6 months | 
| Quality of Life after mesh implantation | Patient will be evaluated with regards to their quality of life outcomes the PROMIS SF 2.0, Ability to Participate in Social Roles and Activities, instrument at 30 days and 6 months from the date of ileostomy closure. | 30 days, 6 months | 
| Bowel Function after mesh implantation | Patient will be evaluated with regards to their bowel function using the Colorectal Functional Outcome (COREFO) instrument at 30 days and 6 months from the date of ileostomy closure. | 30 days, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, hernia, inflammatory bowel disease, IBD