A UK trial will test whether changing how surgeons cut and reconnect the bowel during Crohn’s disease surgery can halve the rate of disease recurrence at the anastomosis site. Crohn’s disease causes chronic inflammation of the digestive tract, often requiring surgery to remove damaged sections of the bowel. Even after successful surgery, the disease returns at the surgical join in up to 50% of patients within a year. The MEErKAT trial compares two surgical techniques—the Kono-S anastomosis and standard anastomosis—combined with either radical or close removal of the mesentery (the fatty tissue attached to the bowel), to see which combination best prevents recurrence. If the trial succeeds, it could establish a new surgical standard for Crohn’s disease, reducing the need for repeat operations, long-term medication, and hospital admissions. The trial also includes a mechanistic substudy to understand *where* and *why* recurrence happens, using mucosal tattoos and immune cell analysis. This could reveal whether recurrence originates from the mesentery or the bowel wall itself, guiding future treatments. The results will directly inform NHS surgical practice within three years.
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DESIGN Multicentre, superiority, 2×2 factorial, randomized, open-label trial with a minimum one-year follow-up. SETTING 12 UK NHS hospitals. POPULATION People undergoing ileocaecal resection for primary/recurrent Crohn’s disease where an anastomosis is carried out. Post operative medical treatment will be in line with the recommendations from the BSG guidelines. INTERVENTIONS Participants will be randomised (1:1:1:1) to one of four groups: (1) Kono-S + radical mesenteric resection; (2) Kono-S + close mesenteric resection; (3) Standard anastomosis + radical mesenteric resection; (4) Standard anastomosis + close mesenteric resection. A mechanistic component will determine in those that develop endoscopic recurrence, the locality and mechanism of that recurrence. OUTCOMES. Primary outcome Time to endoscopic recurrence (after a minimum of 12 months and maximum of 3 years follow-up) using Rutgeert’s score (>/=i2). Secondary outcomes 1. Incidence of severe endoscopic recurrence (Rutgeert’s score >/=i3); 2. Symptomatic recurrence at 12 months and at the end of the trial; 3. Time to recurrence for all groups; 4. Surgical recurrence at a minimum of 12 months and a maximum of three years; 5. Radiological and surgical anastomotic leak as defined by the latest consensus; 6. Other complications for each intervention; 7. Mesenteric disease activity index. Mechanistic outcomes 1. Locality of recurrence 2. Degree and anastomotic locality of peripheral blood mucosal and/or mesenteric fibrocytes and immune factors especially T cell clonality. SAMPLE SIZE We require 308 patients (77 per group; 154 per group for the factorial design) for 90% power; 5% (two-sided) significance, reduction in 1-year endoscopic recurrence from 50% to 30% (hazard ratio 0.515), 104 recurrences, surgeon effects (12 sites, 2 surgeons, ICC 0.01) and 5% attrition. PROJECT TIMETABLE M1-8 set-up; M9-20 internal RCT pilot, M21 stop/go assessment, M21-38 RCT main trial recruitment, M39-50 follow-up only; M51-56: closedown and analysis. ELIGIBILITY CRITERIA People aged 18-75 years with Crohn’s Disease who have been clinically assessed as appropriate for ileocaecal resection and anastomosis. Exclusion criteria include those with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation; undergoing stoma formation; contraindication to subsequent colonoscopy; inability to consent, pregnancy. MECHANISTIC SUBSTUDY The locality of recurrence will be investigated using endoscopic assessment of mucosa relative to mucosal tattoos placed at the time of operation. The degree and anastomotic locality of different fibrocytes and immune cells, focussing on mucosal T cell clonality and exhaustion, especially T cells with CD8 gene expression, will be compared before and after each intervention utilising flow cytometry, multiplex PCR and sequencing and qPCR. COMPLEMENTARY SKILLS Clinical, methodological, statistical, immunological skills + patient experience.
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