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Stoma Closure and Reinforcement Trial ll (SCAR-ll)

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ClinicalTrials.gov Identifier: NCT04916067
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : July 17, 2023
Sponsor:
Collaborator:
Becton, Dickinson and Company
Information provided by (Responsible Party):
Matthew Z. Wilson, Dartmouth-Hitchcock Medical Center

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Inflammatory Bowel Diseases Device: Mesh Implantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Modified Simon-Two Step. An initial cohort of 5 patients will be enrolled and treated sequentially with 30 day follow-up. If stopping criteria are not met, the cohort will be expanded to an additional 15 patients followed concurrently for the duration of the study period
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : June 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Scars

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of wound occurrences [ Time Frame: 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 :
  1. Incidence of hernia formation [ Time Frame: 30 days, 6 months ]
    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.

  2. Quality of Life after mesh implantation [ Time Frame: 30 days, 6 months ]
    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.

  3. Bowel Function after mesh implantation [ Time Frame: 30 days, 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916067


Contacts
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Contact: Matthew Z Wilson, MD, Msc 603-650-8113 Matthew.z.wilson@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Matthew Z Wilson, MD, MSc    603-650-8113    matthew.z.wilson@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Becton, Dickinson and Company
Investigators
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Principal Investigator: Matthew Z Wilson, MD, Msc Dartmouth-Hitchcock Medical Center
More Information
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Publications:

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Responsible Party: Matthew Z. Wilson, Assistant Professor of Surgery, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT04916067    
Other Study ID Numbers: STUDY02000875
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Matthew Z. Wilson, Dartmouth-Hitchcock Medical Center:
ileostomy
hernia
inflammatory bowel disease
IBD
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis