Stoma Closure and Reinforcement Trial

Rectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750461
• Other study ID #: D18101
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2023
• Est. primary completion date: January 30, 2021
• 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 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)

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Ileostomy - Stoma
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Mesh Implantation
Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement 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	Hitchcock Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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