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Stoma Closure and Reinforcement Trial ll (SCAR-ll)

Primary Purpose

Ileostomy - Stoma, Inflammatory Bowel Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mesh Implantation
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ileostomy - Stoma focused on measuring ileostomy, hernia, inflammatory bowel disease, IBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dartmouth Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 1, 2021
Last Updated
July 14, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Becton, Dickinson and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04916067
Brief Title
Stoma Closure and Reinforcement Trial ll
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Becton, Dickinson and Company

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileostomy - Stoma, Inflammatory Bowel Diseases
Keywords
ileostomy, hernia, inflammatory bowel disease, IBD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall
Intervention Type
Device
Intervention Name(s)
Mesh Implantation
Intervention Description
Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation
Primary Outcome Measure Information:
Title
Incidence of wound occurrences
Description
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 Outcome Measure Information:
Title
Incidence of hernia formation
Description
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
Title
Quality of Life after mesh implantation
Description
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
Title
Bowel Function after mesh implantation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18years. Patient is undergoing closure of loop ileostomy. Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery. Exclusion Criteria: Pre-existing systemic infection at the time of ileostomy takedown Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder Previous abdominal hernia repair with mesh placement Concurrent surgical procedures in addition to closure of diverting loop ileostomy Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Z Wilson, MD, Msc
Phone
603-650-8113
Email
Matthew.z.wilson@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Z Wilson, MD, Msc
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Z Wilson, MD, MSc
Phone
603-650-8113
Email
matthew.z.wilson@hitchcock.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32577580
Citation
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.
Results Reference
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Stoma Closure and Reinforcement Trial ll

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