Parastomal Hernia
Conditions
Keywords
Parastomal hernia, end colostomy, prophylactic mesh
Brief summary
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
PROCEDUREPermanent colostomy
A long-term (permanent) colostomy will be performed in the diseased colon or rectum.
Sponsors
Consorci Sanitari Integral
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blinded
Intervention model description
Multicentric randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative parastomal hernia prevention | up to one year post-intervention | proportion of Postoperative parastomal hernias |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative parastomal hernia prevention | 5 years after surgery | proportion of Postoperative parastomal hernias |
| readmissions for complications | up to one year post-intervention | proportion of hospital readmissions |
| morbidity | up to one year post-intervention | Comprehensive Complication Index (CCI) 20 |
Countries
Spain
Contacts
Primary ContactLaura Sobrerroca Porras, MD
Outcome results
None listed