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Comparative Study of Circular Stapling Instruments

This study has been terminated.
(One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399009
First Posted: November 14, 2006
Last Update Posted: June 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Uppsala University Hospital
  Purpose
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.

Condition Intervention
Anastomotic Leak Rectal Cancer Device: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Clinical anastomotic leak

Estimated Enrollment: 880
Study Start Date: January 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399009


Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University Hospital
Investigators
Principal Investigator: Joakim Folkesson, M.D Ph.D. Uppsala University
Principal Investigator: Lars Påhlman, Professor M.D. Ph.D. Uppsala University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00399009     History of Changes
Other Study ID Numbers: Ups03-130
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: June 9, 2008
Last Verified: June 2008

Keywords provided by Uppsala University Hospital:
Circular stapling devices
anastomotic leak
anastomotic dehiscence
rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Anastomotic Leak
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes