OP20 Postoperative endoscopic recurrence after resection of Crohn’s terminal ileitis with Kono-S or side-to-side functional end anastomosis: results of a Multicenter Prospective Randomized Trial

Abstract

Abstract Background A novel anastomosis (Kono-S) was described in 2003 in Crohn’s disease. Subsequent observations have suggested that this anastomosis is associated with lower endoscopic and surgical recurrence rates. The purpose of this study was to compare the endoscopic recurrence between the Kono-S and the side-to-side functional end anastomosis at 3-6 months after resection of Crohn’s terminal ileitis. Methods This was a prospective multi-center randomized trial conducted at eight international centers. Patients with Crohn’s terminal ileitis requiring elective ileocecal resection were randomized to a Kono-S (Group1) or a side-to-side functional end (Group2) anastomosis (Image1). Patients were discharged on no biologicals. Exclusion criteria included age (<18), pregnancy, recurrent or multisite Crohn’s disease, and need of postoperative treatment with biologicals. Data were collected prior to and during surgery, daily after surgery until discharge, at 30 days post-op, and at 3-6 months colonoscopy. Participating surgeons were instructed in the Kono-S technique through videos. Disease clinical activity was measured by Harvey Bradshaw Index (HBI). Endoscopic remission/recurrence was graded with the modified Rutgeerts score: endoscopic remission was defined as a Rutgeerts score of 0, 1, or 2a, and a Rutgeerts score of 2b or higher was considered a recurrence. All study sites had Institutional Review Board approval, ClinicalTrial.gov # NCT03256240. Results We enrolled 288 Crohn’s patients (50.7% female) with a median age of 34 (18-81). 154 patients were randomized to Group 1 (Kono-S) and 134 to Group 2 (Side-to-Side). 30 days follow-up was completed on 278 (96.9%) patients. The Kono-S group had a higher percentage of past smokers (57 vs.30, p = 0.007) and current smokers (33 vs.12, p = 0.004). The mean operative time was 22 minutes longer in the Kono-S group (154 vs.132 minutes; p = 0.386). There was no mortality. 233 (81%) patients underwent a colonoscopy at 3-6 months. There was no significant difference between the two groups in terms of endoscopic recurrence (p = 0.883) and HBI (p = 0.109) or in recurrence-free survival (Log Rank Mantel-Cox test p = 0.256) (Table 1). On multivariable analysis, current smokers had significantly higher odds for endoscopic recurrence at 3-6 months (OR= 2.80, [95% CI =1.10 - 6.92], p = 0.029). Conclusion Kono-S and Side-to-side anastomoses have similar endoscopic recurrence rates at 3-6 months. Independently of surgical techniques, smokers had a significantly higher rate of endoscopic recurrence at 3-6 months after surgery.