NCT00399009

Brief Summary

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.

Trial Health

57
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Trial Health Score

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

Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

June 9, 2008

Status Verified

June 1, 2008

Enrollment Period

3.8 years

First QC Date

November 13, 2006

Last Update Submit

June 5, 2008

Conditions

Anastomotic LeakRectal Cancer

Keywords

Circular stapling devicesanastomotic leakanastomotic dehiscencerectal cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical anastomotic leak

Interventions

AutoSuture Premium Plus CEEA/Ethicon Proximate ILSDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Anterior resection for Rectal Cancer
  • Informed consent

You may not qualify if:

  • Can not give informed consent
  • Patient can not be followed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • Folkesson J, Brown SS, Gunnarsson U, Pahlman L. Randomised multicentre trial of circular stapling devices. Int J Colorectal Dis. 2012 Feb;27(2):227-32. doi: 10.1007/s00384-011-1307-4. Epub 2011 Sep 10.

    PMID: 21909698DERIVED

MeSH Terms

Conditions

Anastomotic LeakRectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Joakim Folkesson, M.D Ph.D.

    Uppsala University

    PRINCIPAL INVESTIGATOR

  • Lars Påhlman, Professor M.D. Ph.D.

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

January 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

June 9, 2008

Record last verified: 2008-06

Locations

SE(1)