Stoma Closure and Reinforcement Trial ll

Inflammatory Bowel Diseases Clinical Trial

— SCAR-ll  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916067
• Other study ID #: STUDY02000875
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 15, 2025

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Matthew Z Wilson, MD, Msc
• Phone: 603-650-8113
• Email: Matthew.z.wilson[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ileostomy - Stoma
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Becton, Dickinson and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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
Secondary	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.	30 days, 6 months
Secondary	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.	30 days, 6 months