Comparative Study of Circular Stapling Instruments

• Sponsor: Uppsala University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00399009
• Collaborator: (none)
• Enrollment: 880
• Location: 1
• Duration (Months): 46
• Patients Per Site Per Month: 19.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anastomotic Leak; Rectal Cancer	Device: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 880 participants
• 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.
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. Clinical anastomotic leak []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00399009
• Other Study ID Numbers: Ups03-130
• First Posted: Nov 14, 2006
• Last Update Posted: Jun 9, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Circular stapling devices; anastomotic leak; anastomotic dehiscence; rectal cancer
• Additional relevant MeSH terms: Rectal Neoplasms; Anastomotic Leak

Study Results

No Results Posted as of Jun 9, 2008