Comparative Study of Circular Stapling Instruments

Uppsala University Hospital

Status: Terminated

Conditions: Rectal Cancer; Anastomotic Leak

Treatments: Device: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Study type: Interventional

Funder types: Other

Identifiers

NCT00399009

Ups03-130

Details and patient eligibility

About

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.

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18
• Anterior resection for Rectal Cancer
• Informed consent

Exclusion criteria

• Can not give informed consent
• Patient can not be followed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)