Stoma Closure and Reinforcement Trial ll (SCAR-ll)

Dartmouth Health

Status: Terminated

Conditions: Ileostomy - Stoma; Inflammatory Bowel Diseases

Treatments: Device: Mesh Implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04916067

STUDY02000875

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Device: Mesh Implantation