Stoma Closure and Reinforcement Trial ll

Dartmouth-Hitchcock Medical Center7 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 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma Inflammatory Bowel Diseases

Interventions

Mesh ImplantationDEVICE

Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - 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 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)

Locations (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 30 days, 6 months

Data from ClinicalTrials.gov

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