Randomized controlled trial of pelvic calcium alginate following rectal cancer surgery

Abstract

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. Methods: 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). © 2010 British Journal of Surgery Society Ltd.