Stoma Closure and Reinforcement Trial ll (SCAR-ll)

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

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 Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Diseases; Ileostomy - Stoma
• Intervention / Treatment: Device: Mesh Implantation

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Wound Occurrences	Number 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 Patient-Reported Outcome Measurement Information System Short Form (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. Data represents mean and standard deviation of the normalized scores. Range for PROMIS Physical Health Score is 16-68 with a higher score being a more positive view, healthy people score 50+ Range for PROMIS Mental Health Score is 21-68, with a higher score representing better functioning, health people score 50+	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. Scores range from 0-100 with lower scores meaning better function (0- No symptoms/ Normal function; 100- Maximum impairment/ worst bowel function)	30 days, 6 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Becton, Dickinson and Company
• Investigators: Principal Investigator: Matthew Z Wilson, MD, Msc, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• Goldwag JL, Wilson LR, Ivatury SJ, Pauli EM, Tsapakos MJ, Wilson MZ. Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial. Contemp Clin Trials Commun. 2020 Jun 9;19:100582. doi: 10.1016/j.conctc.2020.100582. eCollection 2020 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ileostomy; hernia; IBD; inflammatory bowel disease
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Signs and Symptoms; Hernia; Inflammatory Bowel Diseases
• Other Study ID Numbers: STUDY02000875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes