Stoma Closure and Reinforcement Trial

Dartmouth-Hitchcock Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Colon Cancer Rectal Cancer Ileostomy - Stoma

Interventions

Mesh ImplantationDEVICE

Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Quality of Life After Mesh Implantation

Data from ClinicalTrials.gov

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