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Clinical Trials/NCT06533839
NCT06533839
Not yet recruiting
Not Applicable

Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)

Consorci Sanitari Integral1 site in 1 country58 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parastomal Hernia
Sponsor
Consorci Sanitari Integral
Enrollment
58
Locations
1
Primary Endpoint
Postoperative parastomal hernia prevention
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.

Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.

The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
August 1, 2029
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing a definitive colostomy confection
  • Terminal colostomy confection
  • ASA index III or inferior
  • Patients who have given legat authorization to participate in the study

Exclusion Criteria

  • Lateral colostomy or a colostomy that will be removed posteriorly

Outcomes

Primary Outcomes

Postoperative parastomal hernia prevention

Time Frame: up to one year post-intervention

proportion of Postoperative parastomal hernias

Secondary Outcomes

  • morbidity(up to one year post-intervention)
  • Postoperative parastomal hernia prevention(5 years after surgery)
  • readmissions for complications(up to one year post-intervention)

Study Sites (1)

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