OP18 Surgical prevention of anastomotic recurrence by excluding mesentery in Crohn’s disease: The SuPREMe-CD study

Abstract

Background Most patients with Crohn's disease (CD) experience disease recurrence after resection. Recently, a new antimesenteric, functional end-to-end, handsewn ileocolic anastomosis (Kono-S) has been described, showing a significant reduction in endoscopic recurrence (ER) score and surgical recurrence (SR) rate. The aim of this trial was to provide randomized controlled data comparing Kono-S anastomosis to stapled ileocolic side-to-side anastomosis. Methods A randomised controlled trial was conducted at a tertiary referral institution, enrolling and randomising (1:1) to undergo either the ''Kono group'' or the ''Conventional group'', consecutive CD patients needing surgery. The primary endpoint was ER (Rutgeerts score i2) at 6 months, while secondary endpoints were clinical recurrence (CR) at 12 and 24 months, ER at 18 months and SR at 24 months. Short-term outcomes and postoperative complications were also recorded. Postoperative treatment was established on the basis of the patient's risk profile. A sample size of 70 patients (35 in each group) was considered necessary to demonstrate a reduction > 30% in ER at 6 months in the Kono group, when assuming a 60% ER expected rate in the control group. Chi squared, t test and ANOVA binary logistic regressions were performed. Results Seventy- nine CD patients were enrolled and randomized in Kono group (n = 36) or Conventional group (n = 43). At 6 months, 8 patients in the Kono group (22.2%) and 27 in the Conventional group (62.8%) had ER (p<0.01; OR 5.91) (mean Rutgeerts score at 6 months 0.92 + 1.05 and 2.06 + 1.31, respectively, p<0.01). Furthermore, severe postoperative ER (Rutgeerts score i3) was found in 13.8% of the Kono group vs 34.8% in the of Conventional group (p = 0.03; OR 3.32). The CR rate was 8% in the Kono group vs 18% in the Conventional group (p = 0.2) at 12 months and 18% vs 30.2% at 24 months (p = 0.04, OR 3.47). Only 2 patients in the Conventional group and none in the Kono group experienced a SR at 24 months (p = NS). At binary logistic regression, the Kono-S anastomosis was the only variable significantly associated with the reduced risk of ER (OR 0.19, p<0.01). As regards postoperative outcomes, there were no differences between the two groups in terms of operating time, days to canalization, length of postoperative stay and complications (p = N.S.). Conclusions There was a significant reduction of the postoperative endoscopic recurrence rate with the novel technique, without concerns about safety. The Kono-S anastomosis could be considered the new recommended surgical technique in CD.