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 Hémoioni 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).
