Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
Sponsored by Weill Medical College of Cornell University
About this study
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.
Study Aim: * The primary aim of this study is to compare the postoperative recurrence of CD using the modified Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2) and surgical recurrence rate at 60 and 120 months between the groups. Evaluate histologic features in surgical specimen collected at the index surgery as predictors for endoscopic, clinical, and surgical recurrence after ileocecal resection for CD. To evaluate the histological mucosal healing at 60 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2) using Global Histology Activity Score and The Inflammatory Bowel Disease-Distribution, Chronicity, Activity \[IBD-DCA\] score. * The secondary aim is to …
Where this study is enrolling
- I'm interested
Weill Cornell Medical College
New York, New York
Who can participate
Inclusion criteria
- ✓1. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
- ✓2. Age of 18 years and older, male and female
- ✓3. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
- ✓4. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.
Exclusion criteria
- ✕1. Patients under 18 years of age
- ✕2. Patients with recurrent Crohn's
- ✕3. Pregnant patients
- ✕4. Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the time of surgery.
- ✕5. Patients with Crohn's disease extending to the cecum and ascending colon
- ✕6. Patients who will need preventive postoperative medical treatment
- ✕7. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.
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Trial data sourced from ClinicalTrials.gov.