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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00620-49 | Other Identifier | ANSM | |
| 2015/29 | Other Identifier | CPP Nord Ouest II |
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| Name | Class |
|---|---|
| Centre Hospitalier de Beauvais | OTHER |
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During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue.
Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no bridge device | Experimental | After the ileostomy creation, no bridge device was placed. |
|
| bridge device | Active Comparator | A bridge device was placed after the stoma creation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bridge device | Device |
| ||
| no bridge device |
| Measure | Description | Time Frame |
|---|---|---|
| absence of postoperative morbidity | the primary outcome is a composite score. The complication is considered as present if the patient experienced at least one of the following events: surgical site infection (either superficial, deep or distant); a parastomal irritation; a stomal necrosis; parastomal hernia; a stoma stenosis; a stoma prolapsus or a stoma leakage. The primary endpoint is evaluated by a nurse devoted to stoma care according to an open label. | two months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| difficulty of the stoma conception | the difficulty was assessed by the surgeon thanks to a score ranging from 1 to 10. | at the end of the surgery |
| the reoperation rate | the reoperation rate is defined as the number of reoperation one month after the colorectal surgery |
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Inclusion Criteria:
Exclusion Criteria:
Peroperative exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles SABBAGH | CHU Amiens Picardie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Rouen | Rouen | France | 76000 | France | ||
| Amiens Universitary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17667498 | Background | Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024. | |
| 17011918 | Background | Sagap I, Remzi FH, Hammel JP, Fazio VW. Factors associated with failure in managing pelvic sepsis after ileal pouch-anal anastomosis (IPAA)--a multivariate analysis. Surgery. 2006 Oct;140(4):691-703; discussion 703-4. doi: 10.1016/j.surg.2006.07.015. |
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|
| postoperative month one |
| the mortality rate | the mortality rate is defined as the number of deaths one month after the surgery | postoperative month one |
| the postoperative morbidity | the postoperative morbidity is defined according the Clavien - Dindo classification and corresponds to the number of patients with a postoperative outcome | postoperative month one |
| the specific quality of life | the quality of life is assessed with the STOMA QoL form at Baseline, 2, 6 months after the surgery and one year after the surgery | postoperative year one |
| the rate of stoma closure | the rate of stoma closure is defined as the number of patients for whom the stoma was closed 6 months after the colorectal surgery. | 6 months after the surgical procedure |
| the rate of anastomotic fistula | the rate of anastomotic fistula is defined as the number of anastomotic fistula after the colorectal surgery. | 2 months after the colorectal surgery |
| Amiens |
| France |
| Beauvais hospital | Beauvais | France |
| 21997816 | Background | Panis Y, Maggiori L, Caranhac G, Bretagnol F, Vicaut E. Mortality after colorectal cancer surgery: a French survey of more than 84,000 patients. Ann Surg. 2011 Nov;254(5):738-43; discussion 743-4. doi: 10.1097/SLA.0b013e31823604ac. |
| 23095627 | Background | Oberkofler CE, Rickenbacher A, Raptis DA, Lehmann K, Villiger P, Buchli C, Grieder F, Gelpke H, Decurtins M, Tempia-Caliera AA, Demartines N, Hahnloser D, Clavien PA, Breitenstein S. A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg. 2012 Nov;256(5):819-26; discussion 826-7. doi: 10.1097/SLA.0b013e31827324ba. |
| 17672873 | Background | Cottam J, Richards K, Hasted A, Blackman A. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery. Colorectal Dis. 2007 Nov;9(9):834-8. doi: 10.1111/j.1463-1318.2007.01213.x. Epub 2007 Aug 2. |
| 40131588 | Derived | Sabbagh C, Mauvais F, Demouron M, Browet F, Tartar L, Hariz H, Bridoux V, Tuech JJ, Diouf M, Regimbeau JM. Is a bridge (rod) necessary for loop ileostomy? A phase II randomized control trial. Tech Coloproctol. 2025 Mar 25;29(1):87. doi: 10.1007/s10151-025-03132-4. |