Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh

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.

NCT Number	NCT06533839
Lead Sponsor	Consorci Sanitari Integral
Conditions	Parastomal Hernia
Enrollment	58 participants
Start Date	2024-08-01
Primary Completion	2026-08-01 (estimated)
Study Completion	2029-08-01 (estimated)
Updated on ClinicalTrials.gov	2024-08-01