Parastomal Hernia
Conditions
Keywords
Parastomal hernia, wound infection, stoma care.
Brief summary
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.
Detailed description
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes. A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection. Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis. Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.
Interventions
PROCEDUREProphylactic mesh
A low weigth partly absorbable mesh in a subaly posistion
Sponsors
Sundsvall Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical need of an enterostoma
Exclusion criteria
* Patients denies inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound infection,mesh infection, parastomal hernia. | Within five years |
Secondary
| Measure | Time frame |
|---|---|
| Fistula formation, stenosis,pain. | Within five years |
Countries
Sweden
Outcome results
None listed