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Rectal Cancer Trial On Defunctioning Stoma

NCT ID: NCT00636948

Last Updated: 2008-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Absence of intraoperative adverse events according to the study protocol and the operating surgeon.

Exclusion Criteria

* Presence of intraoperative adverse events according to the study protocol and the operating surgeon.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rectal Cancer Trial on Defunctioning Stoma Study Group

OTHER

Sponsor Role lead

Responsible Party

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Department of Surgery, Örebro University Hospital

Principal Investigators

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Rune Sjödahl, MD, PhD

Role: STUDY_CHAIR

Department of Surgery, Linköping University Hospital

Locations

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Department of Surgery, Linköping University Hospital

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 17667498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22889325 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19594606 (View on PubMed)

Other Identifiers

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Dnr 99039

Identifier Type: -

Identifier Source: org_study_id

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