Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial

Ann Surg. 2020 Aug;272(2):210-217. doi: 10.1097/SLA.0000000000003821.


Objective: This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.

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 disease (CD).

Methods: Randomized controlled trial (RCT) at a tertiary referral institution. 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.

Results: In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 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 (hazard ratio 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). There were no differences in postoperative outcomes.

Conclusions: This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety ID NCT02631967.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anastomosis, Surgical / adverse effects*
  • Anastomosis, Surgical / methods
  • Colectomy / methods*
  • Colon / surgery
  • Crohn Disease / diagnosis
  • Crohn Disease / surgery*
  • Endoscopy / adverse effects*
  • Endoscopy / methods
  • Female
  • Follow-Up Studies
  • Humans
  • Ileum / surgery
  • Logistic Models
  • Male
  • Mesentery / pathology*
  • Middle Aged
  • Postoperative Complications / epidemiology
  • Postoperative Complications / physiopathology
  • Proportional Hazards Models
  • Recurrence
  • Risk Assessment
  • Secondary Prevention / methods*
  • Severity of Illness Index
  • Tertiary Care Centers
  • Treatment Outcome

Associated data