NCT00636948

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

Enrollment Period

5.5 years

First QC Date

February 11, 2008

Last Update Submit

March 10, 2008

Conditions

Rectal Cancer

Keywords

Rectal cancer surgerySymptomatic anastomotic leakageDefunctioning stomaTME surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Reoperation within 30 days of initial surgery.

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • Presence of intraoperative adverse events according to the study protocol and the operating surgeon.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Linköping University Hospital

Linköping, 581 85, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 17667498RESULT

  • 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.

    PMID: 22889325DERIVED

  • 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.

    PMID: 19594606DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Rune Sjödahl, MD, PhD

    Department of Surgery, Linköping University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2008

First Posted

March 17, 2008

Study Start

December 1, 1999

Primary Completion

June 1, 2005

Last Updated

March 17, 2008

Record last verified: 2008-03

Locations

SE(1)