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

Abstract

Abstract Background Recently, a new antimesenteric, functional end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn’s disease (CD).This trial aimed to provide randomised controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis. Methods Randomised controlled trial at a tertiary referral institution, enrolling and randomising to undergo either the ‘Kono group’ or the ‘Conventional group’, all CD subjects needing surgery. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months and surgical recurrence (SR) after 24 months. Also, short-term outcomes and postoperative complications were recorded. A sample size of 70 patients (35 in each group) was considered necessary to demonstrate a reduction >30% in endoscopic recurrence at 6 months follow-up in the Kono group when assuming a 60% endoscopic recurrence expected rate in the control group. Results 79 CD patients were enrolled and randomised in the Kono group (36) or Conventional group (43) (Table 1). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER (p < 0.001; OR 5.91). A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono vs. 34.8% of Conventional group (p = 0.03; OR 3.32). CR rate was 8% in the Kono group vs. 18% in the Conventional group after 12 months (p = 0.2) and 18% vs. 30.2% after 24 months (p = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group vs. 4.6% in the Conventional group (p = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (HR 0.36, p = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, p < 0.001). About postoperative outcomes, there were no differences between Kono and Conventional groups in terms of surgery duration (p = 0.8), days to gas (p = 0.4) or stool canalisation (p = 0.8) and postoperative stay (p = 0.3). Infections (included wound infection) were found in 4 subjects in the Kono group (13.7%) vs. 6 patients (16.6%) in the Conventional group (p = 0.749). Conclusion This is the first RCT comparing Kono-S anastomosis vs. standard anastomosis in CD, which found a significant reduction of postoperative endoscopic recurrence rate by using the novel technique, without concerns about safety. The Kono-S anastomosis could be considered the new recommended surgical technique in CD. ClinicalTrial.gov NCT02631967.