Study Comparing Kono-S and Side-to-Side Anastomosis for Crohn's Disease
This study is comparing two surgical techniques, the Kono-S anastomosis and the side-to-side functional end anastomosis, for people with Crohn's disease affecting the small intestine (ileitis) or both the small and large intestines (ileocolitis) who need surgery. Researchers want to see which technique leads to fewer recurrences of Crohn's disease after surgery. You could be eligible if you are 18 to 90 years old, male or female, and have Crohn's ileitis or ileocolitis requiring initial surgery. The study will look at how well each surgery prevents Crohn's disease from coming back, measured by endoscopy (a procedure to look inside your digestive tract) 3 to 6 months after surgery, and by how many people need another surgery for Crohn's disease up to 10 years later. The current status of this study is unclear.
- Study design
- This is a multi-center, randomized study comparing two surgical techniques. It plans to enroll 600 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for endoscopic remission between 3 and 6 months after surgery, and for surgical recurrence at 60 months and 120 months after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
At a glance
Conditions
Where it's being run
15 sites across 13 statesStudy leadership
- Fabrizio Michelassi, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
- Koianka Trencheva, Dr.PH,BSN,MS · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
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What this trial measures
- Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery3-6 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 months60 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 months120 months after surgery
Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
- Mucosal Healing GHS60 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-DCA60 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 Marginsat surgery
Histological evaluation of the surgical pathology margin evaluation for presence or absence of disease