Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis

Condition(s) studied

Investigational drug(s) / intervention(s)

side-to-side functional end anastomosis: type of anastomosis

Kono-S analstomosis: antimesenteric anastomosis

Study summary

This study proposes a randomized prospective study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.

Eligibility

Primary outcome measure(s)

• Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery — 3-6 months after surgery
  Endoscopic remission with a modified Rutgeerts score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. Endoscopic remission is defined as a modified Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.
• Number of subjects with surgical recurrence at 60 months — 60 months after surgery
  Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
• Number of subjects with surgical recurrence at 120 months — 120 months after surgery
  Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
• Mucosal Healing GHS — 60 months after surgery
  Mucosal Healing from colonoscopy biopsies using the modified Global Histology Activity Score (Modified) score between the groups. Global Histology Activity Score (GHAS) is a widely used tool that grades biopsies of the ileum and colonic segments. The score has 8 domains and includes the presence of architectural changes, degree of chronic, neutrophilic and eosinophilic inflammatory infiltration in lamina propria, presence of intraepithelial neutrophils, epithelial damage, mucosal defects, presence of granulomas, and the extent of inflammation (proportion of biopsy specimens affected). Each domain is scored independently, and the total score is the sum of all individual scores, ranging from 2 (being the lowest meaning no histological activity) to 16 (being the highest meaning high histological disease activity).
• Mucosal Healing IBD-DCA — 60 months after surgery
  Mucosal Healing from colonoscopy biopsies using The Inflammatory Bowel Disease-Distribution, Chronicity, Activity \[IBD-DCA\] score between the groups. The score is validated and has 3 domains: 1) Distribution of the disease; 2) Chronicity of the disease; and 3) Activity of the disease. Each domain of the IBD-DCA is scored as one of 0 (normal), 1 (mild), or 2 (moderate to severe) based on the presence of established histological findings and the domains are separately reported. Distribution \[D\] 0=Normal 1. \< 50% of tissue affected per same biopsy site 2. ≥ 50% of tissue affected per same biopsy site Chronic features \[C\] 0=Normal 1=Crypt distortion and/or mild lymphoplasmacytosis 2=Marked lymphoplasmacytosis and/or marked basal plasmacytosis Activity features \[A\] 0=Normal 1. Two or more neutrophils in lamina propria in one high-power field \[HPF\] and/or intraepithelial neutrophils \[any number\] 2. Crypt abscesses, erosions, ulcers
• Surgical Pathology Margins — at surgery
  Histological evaluation of the surgical pathology margin evaluation for presence or absence of disease

Trial sites (15)

More Weill Medical College of Cornell University trials in Italy

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