Background: The aim of this randomized controlled trial was to assess the possible benefit of using a

new haemostatic agent (Hemoionic) 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 Hemoionic (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 Hemoionic 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 Hemoionic group and one of 44 in the

control group (P = 0·192).

Conclusion: Hemoionic may reduce the drainage volume after sphincter-saving surgery for rectal

cancer, but offers no clinical advantage.

Introduction

Sphincter-saving surgery for rectal cancer is associated with high rates of pelvic collection and anastomotic leakage. A recent randomized study demonstrated the benefit of a temporary stoma in reducing symptomatic leakage1. Similarly, a large prospective study suggested that pelvic drainage may reduce symptomatic anastomotic leakage2, although this is controversial3–5. Many surgeons use a temporary stoma and drainage for low pelvic anastomoses. Despite these measures, the rate of leakage remains at between 5 and 18 per cent, leading to significant

morbidity, prolonged hospital stay, poorer function9,10 and  a higher rate of local recurrence11,12.

Hemoionic (Brothier, Nanterre, France), a new haemostatic agent based on calcium alginate, has been developed recently. Its use in the sacral cavity after proctectomy might reduce postoperative collections and the need for prolonged postoperative drainage. This

randomized study assessed the possible benefit of Hemoionic in sphincter-saving surgery for rectal cancer with special reference to reducing pelvic fluid collection.

Methods

This multicentre, randomized parallel-group trial was carried out in 11 general or digestive surgery centres in France. This study was planned in accordance with the CONSORT statement13, and approved by the French ethics committee (Comite Consultatif de Protection des Personnes dans la Recherche Biomedicale) and French drug administration (Agence Fran¸caise de Securit

e Sanitaire des Produits de Sante). The trial received approval from the regional and hospital-based research ethics committees of all participating centres.

Discussion

This randomized study demonstrated that Hemoionic reduces postoperative drainage volume and may decrease the duration of drainage in patients undergoing elective rectal resection for cancer. The mortality rate was non significantly higher in the Hemoionic group, but the lack

of statistical difference may represent a type II error owing

to small sample size.

An all-inclusive definition of anastomotic leakage was used, comprising clinically significant leaks and asymptomatic radiological leaks. The anastomotic leakage  rate of 21 per cent compares favourably with recent findings1,2,17 – 19. The Dutch total mesorectal excision trial reported an overall leakage rate of 12 per cent, but included only clinically significant leakage2.

In sphincter-saving surgery for rectal cancer, reducing postoperative fluid and blood pelvic effusion could be relevant to clinical practice. First, decreasing the duration of drainage could lead to a shorter hospital stay. Second, reducing the volume of pelvic drainage might be beneficial in terms of anastomotic leakage rate and pelvic abscess.

However, neither hospital stay nor anastomotic leakage was decreased with use of Hemoionic in this study.

Alginates have long been known to have haemostatic properties20. The basis of these effects is the formation of a hydrophilic gel, from the ion exchange reaction between calcium of the alginate filaments and sodium in blood and exudate. In a sodium-rich environment, calcium alginate induces rapid release of free calcium ions, providing one of the essential factors in the clotting cascade (factor IV)21. It has been investigated widely and shown to be non-toxic and non-allergenic with little or no local tissue reaction22. Alginate dressings have been used successfully to accelerate human skin-graft site healing21 and to help wound cicatrization14.

The intention-to-treat analysis in this study showed a significant reduction in pelvic drainage volume with the use of Hemoionic. The per-protocol analysis (three patients excluded) demonstrated a significant decrease in the duration of pelvic drainage in the Hemoionic group.

However, there is little to support its routine use and the increased mortality, although possibly unrelated, is of concern.