P587 SuPREMe-CD Study: surgical prevention of anastomotic recurrence by excluding mesentery in Crohn’s disease—preliminary results and trial protocol
G. Luglio*, M. C. Giglio, A. Rispo, R. Peltrini, M. Sacco, V. Sollazzo, C. Bucci, E. Spadarella, F. Terracciano, G. D. De Palma, L. Bucci
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
Around 70%–80% of patients with Crohn’s disease (CD) require surgeries in their lifetime. New drugs have reduced recurrences; nevertheless, the fact that disease in most of CD patients appear at the anastomotic site emphasises the importance of surgical approach. Anastomosis configuration has not been demonstrated as a risk factor for recurrence. Kono  described a new antimesenteric functional end-to-end hand-sewn ileocolic anastomosis. They highlight how anastomotic recurrences always arise at the mesenteric side and speculate that factors such as devascularisation, denervation, and faecal stasis may have a causative role. The authors show a reduction in endoscopic surgical recurrence rate, but their data are not randomised, and the control group is represented by an historical cohort. The aim of this trial is to provide randomised controlled data to compare Kono anastomosis vs the stapled ileocolic side-to-side anastomosis.
This is an ongoing randomised trial, performed at a tertiary referral institution. All consecutive patients (age 18–75) with primary or recurrent ileocolic CD with an indication for surgery are being enrolled. Patients are being randomised to undergo either the ‘Kono group’ or the ‘Conventional group’, using a PC-based randomised model. In total, 8 non-randomised patients underwent Kono anastomosis before trial beginning to assess general safety and feasibility. A sample size of 140 patients is considered necessary to demonstrate a 25% reduction in endoscopic recurrence at 6-month follow-up. Chi-squared test will be used to analyse dichotomous variables, and T-Student and ANOVA will be used for continuous variables. Further univariate and multivariate analysis will be performed with SPSS software. The trial has been approved by the local Ethic Committee (n° 211/15) and is under registration on ClinicalTrial.gov.
In the study, 8 non-randomised patients underwent Kono anastomosis with no anastomotic leak or major morbidity. Median length of stay was 5 days. Endoscopic 6-month evaluation showed no recurrence in 4 patients and a Rutgeerts 2 recurrence in 1 patient. Trial primary endpoint is the endoscopic recurrence score and surgical recurrence rate; endoscopic examination will be performed 6 months after surgery, and preliminary results will be revealed at 2-year median follow-up. Patients will be further follow-up to 5 years. Secondary endpoint is the assessment of short-term outcomes and postoperative complications.
Preliminary non-randomised data on Kono anastomosis are encouraging. Trial will assess if Kono anastomosis is able to significantly reduce endoscopic and surgical recurrences after ileocolic resection for CD.
 A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn’s disease. Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.