Comparative Study of Circular Stapling Instruments
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ClinicalTrials.gov Identifier: NCT00399009
Recruitment Status :
(One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.)
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
Anastomotic LeakRectal Cancer
Device: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS
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