Stoma Closure and Reinforcement Trial

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 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.

Official Title
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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

Conditions
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Colon Cancer, Rectal Cancer, Ileostomy - Stoma

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 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)

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 permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 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 | 
| Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary Efficacy Based on Number of Participants With Hernia Formation | Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination. | 30 days, and then 6 months post procedure | 
| Bowel Function After Mesh Implantation | Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function. | 2 years | 
| Quality of Life After Mesh Implantation | Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, hernia, rectal cancer, colon cancer