Stoma Closure and Reinforcement Trial ll

Not Applicable

Terminated

• Conditions: Inflammatory Bowel Diseases; Ileostomy - Stoma
• Interventions: Device: Mesh Implantation

• Registration Number: NCT04916067
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-07
• Study Start: 2021-12-01
• Status Verified: 2024-08
• Primary Completion: 2024-08-05
• Study Completion: 2024-08-05
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Mesh Implantation	Patients undergoing mesh implantation during ileostomy closure to reinforce the abdominal wall

Primary Outcome Measures

Name	Time	Method
Incidence of wound occurrences	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

Name	Time	Method
Quality of Life after mesh implantation	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.
Bowel Function after mesh implantation	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.
Incidence of hernia formation	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.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States