- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399009
Comparative Study of Circular Stapling Instruments
June 5, 2008 updated by: Uppsala University Hospital
Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
880
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden, 751 85
- Uppsala University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age over 18
- Anterior resection for Rectal Cancer
- Informed consent
Exclusion Criteria:
- Can not give informed consent
- Patient can not be followed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical anastomotic leak
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joakim Folkesson, M.D Ph.D., Uppsala University
- Principal Investigator: Lars Påhlman, Professor M.D. Ph.D., Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
November 13, 2006
First Submitted That Met QC Criteria
November 13, 2006
First Posted (Estimate)
November 14, 2006
Study Record Updates
Last Update Posted (Estimate)
June 9, 2008
Last Update Submitted That Met QC Criteria
June 5, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ups03-130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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