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Studies

Interventional Recruiting

NCT04510558 on ClinicalTrials.gov

Reducing the Incidence of Incisional Hernia After Stoma Closure Using a Prophylactic Mesh

Official title: Reducing the Incidence of Incisional Hernia After Stoma Closure Using a PROphylactic MESH: a Single-blinded Randomized Controlled Trial (PROMESH TRIAL).

  • Sponsor: Geneva General Hospital
  • Enrollment: 72 (Estimated)
  • Study start: 2021-05-01 (Actual)
  • Primary completion: 2024-05-01 (Estimated)
  • Study completion: 2024-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Patients will be recruited during the preoperative consultation. Patients will be given written information related to the study and will sign an informed consent form. Investigators will be contacted and perform randomization using the RedCap (Research Electronic Data Capture) software system on a 1:1 allocation ratio between study groups. The surgery planning form will be forwarded to the investigators, which will indicate if a mesh should be added or not to the stoma closure procedure.
  • Masking: Single (Participant)
  • PrimaryPurpose: Prevention

Brief Summary

Background:

Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure.

Methods/Design:

The study will be a randomized controlled single-blinded monocentric study determining the 1-year incidence of incisional hernia in cancer patients undergoing ileostomy or colostomy closure with or without prophylactic non-absorbable mesh applied in the sublay position.

Discussion:

Prevention of incisional hernia at site of stoma closure will lead to an improvement in patients' quality of life and generating savings for healthcare systems. To date, no randomized controlled trial assessing the effect of prophylactic mesh applied during stoma closure on the prevention of incisional hernia has been published. With the present randomized controlled trial, we expect to demonstrate that the application of a prophylactic mesh reduces the one-year incidence of incisional hernia at site of stoma closure.

Conditions

  • Incisional Hernia

Intervention / Treatment

  • Device: Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position
  • Procedure: Stoma closure without mesh

Primary Outcome Measures

  • Incidence of incisional hernia at site of stoma at one year after closure (At one year after stoma closure)
    The presence or not of an incisional hernia will be assessed clinically by a specialist in general surgery and radiologically by computed tomography realized in the setting of cancer followup. The investigator performing the 1-year follow-up and the radiologist interpreting the CTscan will be blinded for the study group. Patients diagnosed with incisional hernia and/or reoperated for a complication related to stoma closure and/or mesh will be considered as treatment failure.

Countries

Switzerland

Locations and Investigators

  • University Hospitals of Geneva, Geneva, Switzerland (Recruiting)
    • Nicolas Buchs, MD, PD
    • Vaihere Delaune, MD-PhD

Study Officials