NCT00399009

Comparative Study of Circular Stapling Instruments

Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Uppsala University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anastomotic Leak
• Rectal Cancer

Interventions

Type	Name	Description
DEVICE	AutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-11-14
• Last updated: 2008-06-09

Locations

1 site across 1 country: Sweden