Back to resultsComparative Study of Circular Stapling Instruments
Primary Purpose
Anastomotic Leak, Rectal Cancer
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
AutoSuture Premium Plus CEEA/Ethicon Proximate ILS
Sponsored by
About this trial
This is an interventional treatment trial for Anastomotic Leak focused on measuring Circular stapling devices, anastomotic leak, anastomotic dehiscence, rectal cancer
Eligibility Criteria
Inclusion Criteria:
- Age over 18
- Anterior resection for Rectal Cancer
- Informed consent
Exclusion Criteria:
- Can not give informed consent
- Patient can not be followed
Sites / Locations
- Uppsala University Hospital
Outcomes
Primary Outcome Measures
Clinical anastomotic leak
Secondary Outcome Measures
Full Information
NCT ID
NCT00399009
First Posted
November 13, 2006
Last Updated
June 5, 2008
Sponsor
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00399009
Brief Title
Comparative Study of Circular Stapling Instruments
Official Title
Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak, Rectal Cancer
Keywords
Circular stapling devices, anastomotic leak, anastomotic dehiscence, rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
880 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
AutoSuture Premium Plus CEEA/Ethicon Proximate ILS
Primary Outcome Measure Information:
Title
Clinical anastomotic leak
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18
Anterior resection for Rectal Cancer
Informed consent
Exclusion Criteria:
Can not give informed consent
Patient can not be followed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joakim Folkesson, M.D Ph.D.
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Påhlman, Professor M.D. Ph.D.
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21909698
Citation
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.
Results Reference
derived
Learn more about this trial
Comparative Study of Circular Stapling Instruments
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