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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(One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.)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:
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT00399009
First received: November 13, 2006
Last updated: June 5, 2008
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Uppsala University Hospital

Additional 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
Study First Received: November 13, 2006
Last Updated: June 5, 2008
Health Authority: Sweden: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013