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