Parastomal Hernia, Terminal Colostomy
Conditions
Keywords
strattice, colostomy, parastomal hernia
Brief summary
In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases. To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception. Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.
Interventions
DEVICEstrattice
use of a strattice
PROCEDURENo strattice
no use of a strattice
Sponsors
LifeCell
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requiring a colorectal surgery with a terminal colostomy * Elective or emergency surgery
Exclusion criteria
* Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI. * Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability. * Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs * Is pregnant, or lactating. * Allergic to any porcine or collagen products. * survival \< 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of parastomal hernia | postoperative month 6 | the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the pain | 2 years after the surgery | The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery |
| the postoperative morbidity | postoperative month 1 | the postoperative morbidity will be assessed with the Dindo Clavien classification |
| the parastomal hernia rate | postoperative year 1 | The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination |
| the quality of life | 2 years after the surgery | The quality of life will be assessed with the STOMA QoL form, the 12-Item Short Form Health Survey (SF12) and the Carolina comfort scale at 1 month, 6 months, 1 year and 2 years after the surgery |
Countries
France
Outcome results
None listed