Comparative Study of Circular Stapling Instruments

Not Applicable

Terminated

• Conditions: Anastomotic Leak; Rectal Cancer

• Registration Number: NCT00399009
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-05
• Last Update Posted: 2008-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 880

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical anastomotic leak

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden