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The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.
The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma. | 30 days, one year and five years. |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation within 30 days of initial surgery. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients operated for rectal cancer in whom low anteriror resection with or without preoperative adjuvant treatment was the planned treatment, who did not have any intraoperative adverse events and who had accepted participation.
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| Name | Affiliation | Role |
|---|---|---|
| Rune Sjödahl, MD, PhD | Department of Surgery, Linköping University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Linköping University Hospital | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17667498 | Result | 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. | |
| 22889325 | Derived | Floodeen H, Hallbook O, Rutegard J, Sjodahl R, Matthiessen P. Early and late symptomatic anastomotic leakage following low anterior resection of the rectum for cancer: are they different entities? Colorectal Dis. 2013 Mar;15(3):334-40. doi: 10.1111/j.1463-1318.2012.03195.x. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 19594606 | Derived | Matthiessen P, Lindgren R, Hallbook O, Rutegard J, Sjodahl R; Rectal Cancer Trial on Defunctioning Stoma Study Group. Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection for rectal cancer. Colorectal Dis. 2010 Jul;12(7 Online):e82-7. doi: 10.1111/j.1463-1318.2009.01938.x. Epub 2009 Jul 7. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |