Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Permanent colostomy.
- Who it may be relevant to
- Registry conditions: Parastomal Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)
Overview
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.
Interventions
- Procedure Permanent colostomy
A long-term (permanent) colostomy will be performed in the diseased colon or rectum.
Primary outcome measures
- Postoperative parastomal hernia prevention [Time frame: up to one year post-intervention]
Secondary outcome measures (3)
- Postoperative parastomal hernia prevention [Time frame: 5 years after surgery]
- readmissions for complications [Time frame: up to one year post-intervention]
- morbidity [Time frame: up to one year post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Sant Joan Despí Moisès Broggi — Sant Joan Despí
Identifiers
NCT: NCT06533839 · 24/20