Randomized controlled trial of pelvic calcium alginate following rectal cancer surgery.
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).


CONCLUSIONS
Hémoionic may reduce the drainage volume after sphincter-saving surgery for rectal cancer, but offers no clinical advantage.


BACKGROUND
ISRCTN79721331 (http://www.isrctn.org).
Department of Colorectal Surgery, Pôle des Maladies de l'Appareil Digestif, Beaujon Hospital, Assistance Publique-Hôpitaux de Paris, Clichy, France.
L
L
Maggiori
E
E
Rullier
C
C
Meyer
G
G
Portier
J L
JL
Faucheron
Y
Y
Panis
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000464:Alginates / Q000008:administration & dosage* / Q000191:economics; D015992:Body Mass Index; D003365:Costs and Cost Analysis; D020723:Glucuronic Acid / Q000008:administration & dosage / Q000191:economics; D006490:Hemostatics / Q000008:administration & dosage* / Q000191:economics; D006603:Hexuronic Acids / Q000008:administration & dosage / Q000191:economics; D006801:Humans; D008875:Middle Aged; D011182:Postoperative Care / Q000191:economics / Q000379:methods; D012004:Rectal Neoplasms / Q000191:economics / Q000401:mortality / Q000601:surgery*; D013396:Suction / Q000191:economics / Q000379:methods
D000464:Alginates; D006490:Hemostatics; D006603:Hexuronic Acids; D020723:Glucuronic Acid