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Randomized controlled trial of pelvic calcium alginate following rectal cancer surgery. BJS 2010; 97: 479-484.

Published: 12th February 2010

Authors: L. Maggiori, E. Rullier, C. Meyer, G. Portier, J. L. Faucheron, Y. Panis et al.

Background

The aim of this randomized controlled trial was to assess the possible benefit of using a new haemostatic agent (Hémoionic®) in the pelvic cavity in sphincter‐saving surgery for rectal cancer.

Method

Eighty‐five patients undergoing elective sphincter‐saving rectal resection for cancer were randomized into Hémoionic® (41 patients) and control (44) groups. In both groups, a pelvic suction drain was left in place for as long as the daily output exceeded 20 ml. The primary endpoint was volume of fluid collected by the suction drain; secondary endpoints were duration of drainage, and postoperative mortality and morbidity rates.

Results

The mean total drainage volume was significantly lower in the Hémoionic® group (453 ml versus 758 ml in control group; P = 0·031). There was no significant difference between groups in duration of drainage and morbidity. The mortality rate was four of 41 in the Hémoionic® group and one of 44 in the control group (P = 0·192).

Conclusion

Hémoionic® may reduce the drainage volume after sphincter‐saving surgery for rectal cancer, but offers no clinical advantage. Registration number: ISRCTN79721331 (http://www.isrctn.org). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

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