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

Consorci Sanitari Integral

Status: Not yet enrolling

Conditions: Parastomal Hernia

Treatments: Procedure: Permanent colostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06533839

24/20

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

IPST mesh placement

Experimental group

Description:

A three-dimensional, funnel-shaped mesh will be used.

Treatment:

Procedure: Permanent colostomy

No mesh

Active Comparator group

Description:

No mesh will be applied.

Treatment:

Procedure: Permanent colostomy