Stoma Closure and Reinforcement Trial

Not Applicable

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Intervention	Mesh Implantation	Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls	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	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 Outcome Measures

Name	Time	Method
Preliminary Efficacy Based on Number of Participants With Hernia Formation	30 days, and then 6 months post procedure	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.
Bowel Function After Mesh Implantation	2 years	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.
Quality of Life After Mesh Implantation	2 years	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