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

Not Applicable

Not yet recruiting

• Conditions: Parastomal Hernia
• Interventions: Procedure: Permanent colostomy

• Registration Number: NCT06533839
• Lead Sponsor: Consorci Sanitari Integral

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study Start: 2024-08-01
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPST mesh placement	Permanent colostomy	A three-dimensional, funnel-shaped mesh will be used.
No mesh	Permanent colostomy	No mesh will be applied.

Primary Outcome Measures

Name	Time	Method
Postoperative parastomal hernia prevention	up to one year post-intervention	proportion of Postoperative parastomal hernias

Secondary Outcome Measures

Name	Time	Method
morbidity	up to one year post-intervention	Comprehensive Complication Index (CCI) 20
Postoperative parastomal hernia prevention	5 years after surgery	proportion of Postoperative parastomal hernias
readmissions for complications	up to one year post-intervention	proportion of hospital readmissions

Trial Locations

Locations (1)

Hospital Sant Joan Despí Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain