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Oral presentations: Scientific session 5: Cartels in IBD (Part 1) (2020)

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

G. Luglio, A. Rispo, N. Imperatore, A. Amendola, F.P. Tropeano, R. Peltrini, F. Castiglione, G.D. De Palma, L. Bucci

Department of Clinical Medicine, Gastroenterology and Surgery, Federico II University of Naples, 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 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.