Stoma Closure and Reinforcement Trial ll

Last updated: August 5, 2024
Sponsor: Dartmouth-Hitchcock Medical Center
Overall Status: Terminated

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

Mesh Implantation

Clinical Study ID

NCT04916067
STUDY02000875
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anddiverting loop ileostomy.

  4. Patient has been evaluated by a qualified surgeon and found to be a suitablecandidate for surgery.

Exclusion

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. thoserequiring exploratory laparotomy for closure)

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: Mesh Implantation
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
August 05, 2024

Connect with a study center

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

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