NCT06533839

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Consorci Sanitari Integral · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
PROCEDURE	Permanent colostomy	A long-term (permanent) colostomy will be performed in the diseased colon or rectum.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2029-08-01
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

1 site across 1 country: Spain