Stoma Closure and Reinforcement Trial (SCAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Colon Cancer; Ileostomy - Stoma
• Intervention / Treatment: Device: Mesh Implantation

• Study Type: Interventional
• Enrollment (Actual): 20
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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 permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days, and then 6 months post procedure
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.	2 years
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	2 years

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Hitchcock Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ileostomy; rectal cancer; hernia; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: D18101

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