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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
use of a strattice
no use of a strattice
Amiens Universitary Hospital
Amiens, France
Amiens university hospital
Amiens, France
Beauvais hospital
Beauvais, France
Caen hospital
Caen, France
Claude Huriet Hospital
Lille, France
Lariboisiere Hospital
Paris, France
Charles Nicolle Hospital
Rouen, France
rate of parastomal hernia
the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan
Time frame: postoperative month 6
evaluation of the pain
The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery
Time frame: 2 years after the surgery
the postoperative morbidity
the postoperative morbidity will be assessed with the Dindo Clavien classification
Time frame: postoperative month 1
the parastomal hernia rate
The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
Time frame: postoperative year 1
the quality of life
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
Time frame: 2 years after the surgery
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