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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Permanent colostomy
Procedure/SurgeryA long-term (permanent) colostomy will be performed in the diseased colon or rectum.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative parastomal hernia prevention
proportion of Postoperative parastomal hernias
Secondary outcomes
Postoperative parastomal hernia prevention
proportion of Postoperative parastomal hernias
readmissions for complications
proportion of hospital readmissions
morbidity
Comprehensive Complication Index (CCI) 20
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: