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Stoma Closure and Reinforcement Trial (SCAR)

Primary Purpose

Colon Cancer, Rectal Cancer, Ileostomy - Stoma

Status
Completed
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 Colon Cancer focused on measuring ileostomy, hernia, rectal cancer, colon cancer

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 left sided colon or rectal cancer 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. On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone >10mg/day)
  4. Previous abdominal hernia repair with mesh placement
  5. Concurrent procedures in addition to closure of diverting loop ileostomy
  6. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)

Sites / Locations

  • Dartmouth Hitchcock Medical Center

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

Number of Participants With 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.
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
The 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 30days, 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 compared to historical controls.

Secondary Outcome Measures

Preliminary Efficacy Based on Number of Participants With Hernia Formation
Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.
Bowel Function After Mesh Implantation
Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.
Quality of Life After Mesh Implantation
Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life

Full Information

First Posted
November 13, 2018
Last Updated
February 20, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Hitchcock Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03750461
Brief Title
Stoma Closure and Reinforcement Trial
Acronym
SCAR
Official Title
Stoma Closure and Reinforcement (SCAR) Trial - A Single Center Pilot Study of the Safety of a Mesh Reinforcement of Ileostomy Closure to Prevent Hernia Formation in Left Sided Colon and Rectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Hitchcock Foundation

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 large pore monofilament polypropylene 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
Colon Cancer, Rectal Cancer, Ileostomy - Stoma
Keywords
ileostomy, hernia, rectal cancer, colon cancer

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 (Actual)

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 permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation
Primary Outcome Measure Information:
Title
Number of Participants With 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
Title
Number of Participants With Wound Occurrences in Current Study Compared to Historical Controls
Description
The 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 30days, 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 compared to historical controls.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Preliminary Efficacy Based on Number of Participants With Hernia Formation
Description
Evaluation of the incidence of hernia formation at the ileostomy site on a prospective basis at 30 days and 6 month intervals thereafter until two years from the date of ileostomy closure using computed tomography and clinical examination.
Time Frame
30 days, and then 6 months post procedure
Title
Bowel Function After Mesh Implantation
Description
Patient will be evaluated with regards to their bowel function outcomes utilizing the Colorectal Function Outcome (COREFO) instrument to evaluate bowel function. Score range is 0-100, Higher score indicates worse bowel function.
Time Frame
2 years
Title
Quality of Life After Mesh Implantation
Description
Patient will be evaluated with regards to their quality of life outcomes utilizing the Promis SF 2.0 8a Ability to Participate in Social Roles and Activities instrument. Score range is 0-40, Higher scores represents better quality of life
Time Frame
2 years

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 left sided colon or rectal cancer 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 On current immunosuppression (anti-tumor necrosis factor (TNF) agents, chemotherapy, or prednisone >10mg/day) Previous abdominal hernia repair with mesh placement Concurrent 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)
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

12. IPD Sharing Statement

Plan to Share IPD
No

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Stoma Closure and Reinforcement Trial

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