Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01461-44 | Other Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LifeCell | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strattice | Experimental | a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception |
|
| No strattice | Placebo Comparator | the colostomy is not reinforced with a mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| strattice | Device | use of a strattice |
| |
| No strattice |
| Measure | Description | Time Frame |
|---|---|---|
| rate of parastomal hernia | the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan | postoperative month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years after the surgery |
| the postoperative morbidity | the postoperative morbidity will be assessed with the Dindo Clavien classification |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| jean marc regimbeau, MD, PhD | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens Universitary Hospital | Amiens | France | ||||
| Amiens university hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24238119 | Background | Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12. | |
| 24210147 | Background | Lee L, Saleem A, Landry T, Latimer E, Chaudhury P, Feldman LS. Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer. J Am Coll Surg. 2014 Jan;218(1):82-91. doi: 10.1016/j.jamcollsurg.2013.09.015. Epub 2013 Sep 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
no use of a strattice |
|
| postoperative month 1 |
| the parastomal hernia rate | The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination | 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 | 2 years after the surgery |
| Amiens |
| France |
| Beauvais hospital | Beauvais | France |
| Caen hospital | Caen | France |
| Claude Huriet Hospital | Lille | France |
| Lariboisiere Hospital | Paris | France |
| Charles Nicolle Hospital | Rouen | France |
| 3374759 | Background | Swann JM, Turek FW. Transfer from long to short days reduces the frequency of pulsatile luteinizing hormone release in intact but not in castrated male golden hamsters. Neuroendocrinology. 1988 Apr;47(4):343-9. doi: 10.1159/000124935. |