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

Abstract

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 issues. ClinicalTrials.gov ID NCT02631967.

The role of Kono‐S anastomosis and mesenteric resection in reducing recurrence after surgery for Crohn’s disease: a systematic review

“…Participant characteristics are given in Table 2. For the analysis involving the Kono‐S anastomosis, the studies involving a comparator included end‐to‐end [15] or side‐to‐side anastomoses [32] or both [8]. For the analysis involving mesenteric excision, the comparator was preservation of the mesentery (division of the mesentery flush with the intestine).…”

“…Endoscopic recurrence was significantly lower in the Kono‐S group compared to the standard anastomosis group. Results from the RCT [32] showed a mean Rutgeerts score of i,1.05 ± 1.06 at 18 months for the Kono‐S group compared with i,2.30 ± 1.32 in the conventional group. A Rutgeerts score of above i,2, indicating a higher risk of symptomatic recurrence, was seen in 9/36 patients (25%) after a Kono‐S anastomosis compared with 29/43 (67.4%) in the conventional anastomosis group.…”

Localization of recurrent lesions following ileocolic resection for Crohn's disease

“…Shimada N et al reported that the 5-year surgery-free survival rate at the site of anastomosis in patients who underwent Kono-S anastomosis (95%) was signi cantly higher as compared to those who received an end-to-end anastomosis procedure (81.3%; p<0.001) [11]. Furthermore, in the rst randomized clinical trial to compare Kono-S and conventional side-to-side anastomosis procedures in CD patients, Luglio G et al reported results demonstrating a signi cant reduction in postoperative endoscopic and clinical recurrence rates for patients who underwent Kono-S anastomosis [12].…”

Localization of recurrent lesions following ileocolic resection for Crohn's disease

“…With this technique, the supporting column prevents distortion and keeps the intestinal tract in the anastomosis region straight, which also makes endoscopic examination and balloon dilatation following surgery easier to perform. Shimada N et al reported that the 5-year surgery-free survival rate at the site of anastomosis in patients who underwent Kono-S anastomosis (95%) was signi cantly higher as compared to those who received an end-to-end anastomosis procedure (81.3%; p<0.001) [11]. Furthermore, in the rst randomized clinical trial to compare Kono-S and conventional side-to-side anastomosis procedures in CD patients, Luglio G et al reported results demonstrating a signi cant reduction in postoperative endoscopic and clinical recurrence rates for patients who underwent Kono-S anastomosis [12].…”