SuPREMe-CD
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Clinical Question
Does the Kono-S anastomosis reduce endoscopic or clinical recurrence compared to a conventional stapled side-to-side anastomosis following ileocolic resection for Crohn’s disease?
Bottom Line
The SuPREMe-CD trial demonstrated that Kono-S anastomosis significantly reduced endoscopic recurrence at 6 and 18 months, and clinical recurrence at 24 months, compared to conventional stapled side-to-side anastomosis in patients undergoing ileocolic resection for Crohn’s disease. The Kono-S technique was also associated with better bowel-related quality of life and social functioning at long-term follow-up.
Major Points
The SuPREMe-CD trial is the first randomized controlled trial comparing Kono-S and stapled side-to-side anastomosis after ileocolic resection in Crohn’s disease. Among 79 patients, the Kono-S group had lower rates of endoscopic recurrence at 6 months (22% vs. 63%) and 18 months (25% vs. 67%), as well as lower clinical recurrence at 24 months (11% vs. 30%). No significant differences in surgical recurrence or postoperative complications were observed. A follow-up quality-of-life analysis showed Kono-S was associated with improved bowel symptom and social function scores on the IBDQ at a mean of 54 months post-op.
Guidelines
- ECCO guidelines recommend stapled side-to-side anastomosis as standard but acknowledge emerging data on Kono-S technique.
- Long-term monitoring post-ileocolic resection should include endoscopic surveillance due to high recurrence risk.
Design
- Phase II, open-label, randomized controlled trial
- N=79 adult patients with primary or recurrent ileocolic Crohn’s disease
- Single center: University of Naples Federico II
- Randomization: 1:1 to Kono-S or conventional side-to-side anastomosis
- Follow-up: 24 months (clinical), 18 months (endoscopic), 54 months (QoL)
- Primary endpoint: Endoscopic recurrence (Rutgeerts ≥i2) at 6 months
- Secondary endpoints: Endoscopic recurrence at 18 months, clinical recurrence at 12 and 24 months, surgical recurrence, quality of life
Population
Inclusion Criteria
- Adults aged 18–75
- Medically refractory, stricturing, or penetrating ileocolic Crohn’s disease
- Undergoing ileocolic resection
Exclusion Criteria
- Presence of ostomy
- Contraindications to endoscopy
- Pregnancy or refusal of consent
Baseline Characteristics
- Median age: 34 (Kono) vs. 43 (conventional)
- Disease behavior: ~44% fistulizing, ~40% stricturing in both groups
- Prior surgery: 52% (Kono) vs. 65% (conventional)
- Smoking: ~30% in both groups
- Laparoscopy used in ~50% of cases
Interventions
- Kono-S anastomosis: Handsewn, antimesenteric, functional end-to-end with central supporting column
- Conventional: Stapled side-to-side anastomosis using linear GIA
- All patients received 1-month course of metronidazole
- Medical therapy post-op individualized based on clinical judgment
Outcomes
Primary Outcome
- Endoscopic recurrence at 6 months (Rutgeerts ≥i2)
- 22.2% (Kono) vs. 62.8% (Conventional), p<0.001
Secondary Outcomes
- Endoscopic recurrence at 18 months
- 25% (Kono) vs. 67.4% (Conventional), p<0.001
- Clinical recurrence (CDAI >200)
- 24 months: 11.1% (Kono) vs. 30.2% (Conventional), p=0.04
- Surgical recurrence
- 0% (Kono) vs. 4.6% (Conventional), p=NS
- Quality of Life (mean follow-up 54 months)
- Higher IBDQ bowel symptom (56.3 vs. 50.7) and social function (26.5 vs. 23.5) scores with Kono-S
- Kono-S independently associated with improved QoL on multivariable analysis
- Postoperative complications
- Similar between groups; no significant difference in abscess, ileus, or wound infection
Criticisms
- Single-center design limits generalizability.
- Blinding not possible due to surgical technique.
- Lack of standardization in postoperative medical therapy.
- QoL analysis did not include preoperative baseline scores.
Funding
- Study registered at ClinicalTrials.gov (NCT02631967)
- No conflicts of interest reported
Further Reading
- Cricrì M, et al. Impact of Kono‐S anastomosis on quality of life after ileocolic resection in Crohn's. Colorectal Dis. 2024;26(7):1428–1436. [1](https://doi.org/10.1111/codi.17073)