Hospital Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970, Spain
NCT Number: NCT06533839
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Sant Joan Despí, Barcelona, 08970, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A long-term (permanent) colostomy will be performed in the diseased colon or rectum.
Time frame: up to one year post-intervention
proportion of Postoperative parastomal hernias
Time frame: 5 years after surgery
proportion of Postoperative parastomal hernias
Time frame: up to one year post-intervention
proportion of hospital readmissions
Time frame: up to one year post-intervention
Comprehensive Complication Index (CCI) 20
Contact information is provided by the study sponsor or research team.
Consorci Sanitari Integral
Other
Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)
Acronym: PREVEMAC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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