P522 Kono-S anastomosis reduces endoscopic and surgical post-operative recurrence in Crohn’s disease. The SuPREMe-CD Trial Update.
Luglio, G.(1)*;Rispo, A.(2);Tropeano, F.P.(3);Giglio, M.C.(4);Cricrì, M.(4);Imperatore, N.(5);De Sire, R.(4);Guarino, A.D.(4);Bucci, L.(6);Castiglione, F.(4);De Palma, G.D.(4);
(1)University of Naples Federico II, Department of Public Health - Surgical Endoscopy Unit, Napoli, Italy;(2)University of Naples Federico II, Department of Clinical Medicine and Surgery - Gastroenterology Unit, Naples, Italy;(3)University of Naples Federico II, Department of Advanced Biomedical Sciences, Naples, Italy;(4)University of Naples Federico II, Department of Clinical Medicine and Surgery, Naples, Italy;(5)Ospedale Santa Maria delle Grazie Pozzuoli, Department of Medicine, Pozzuoli, Italy;(6)University of Naples Federico II, Department of Clinical Medicine and Surgery, Naples, Italy;
Background
Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence (ER) and surgical recurrence (SR) rate in Crohn’s disease (CD). This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and conventional stapled ileocolic side-to-side anastomosis.
Methods
Randomized controlled trial (RCT) at a tertiary referral centre. The primary endpoint is ER rate (Rutgeerts score > i2) after 6 months and surgical recurrence at 60 months. Secondary endpoints are clinical recurrence (CR) rate after 24 and 36 months, and SR after 24 and 36 months. Statistics was performed by using standard analyses. Furthermore, a sample size able to consent the detection of a reduction >30% in total endoscopic recurrence (when assuming a 60% to 65% ER expected rate in the control group and a 30% in the case group) was calculated; to allow a 10% drop-out of patients, 36 patients per group were needed (72 patients in the entire population).
Results
A total of 119 CD patients were included in the study. In all, 51 ileocolic CD patients were randomized in the Kono group and 68 in the conventional side-to-side group.
At 6 months, 17 (33.3%) patients in the Kono group and 51 (75%) patients in the conventional group presented an ER (Rutgeerts score>i2) at colonoscopy (p<0.001). A severe post-operative ER (Rutgeerts score>i3) was found in 8 (15.7%) patients in the Kono group versus 23 (33.8%) patients in the conventional group (p=0.03).
At 24 months, CR rate was 19.6% in the Kono group versus 30.9% in the conventional group (p=0.2), while SR rate was 0% in the Kono group versus 4.4% (3 patients) in the standard group (p=0.2).
At 36 months, CR rate was 19.6% in the Kono-s group versus 33.8% in the conventional group (p=0.1). At 36 months, no patients (0%) in the Kono group experienced SR, while 6 patients (8.8%) in the conventional group did (p=0.03).
Furthermore, when considering a median follow-up of 54 (42-60) months at interim analysis of SR, the difference between the two groups was confirmed to be significant (0% vs 8.8%; p=0.02).
Conclusion
This is the first RCT comparing Kono-S anastomosis and conventional side-to-side anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and surgical recurrence rates, no safety issues, and a favourable trend for lower clinical recurrence rate in patients who underwent Kono-S anastomosis compared to the conventional side-to-side anastomosis.