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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorci Sanitari Integral

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Lateral colostomy or a colostomy that will be removed posteriorly

Trial design

Treatments tested in this trial

  • Permanent colostomy

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators