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

Summary

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Description

Study Aim: The primary aim of this study is to compare the post-operative recurrence of CD using the Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2). The secondary aim is to evaluate the post-operative recurrence of CD ...

Study Aim: The primary aim of this study is to compare the post-operative recurrence of CD using the Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2). The secondary aim is to evaluate the post-operative recurrence of CD using the Rutgeerts score at 12-18 months, surgical recurrence rate at 60 months between the groups. Methods Design: This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring initial resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis. Patients will be randomized into two Groups: Group 1: Kono-S anastomosis vs. Group 2: side-to-side functional end anastomosis. The purpose of this study is to compare the post-operative recurrence of Crohn's disease between Kono-S procedure and the side-to-side functional end anastomosis. In any intestine surgery, after the sick portion of the bowel is removed, the intestinal tract is restored by reconnecting the healthy ends together. The new connecting line is called anastomosis, and could be created in a variety ways by the surgeon. This study will compare two different intestinal connections called Kono-S anastomosis and the traditional side-to-side functional end anastomosis. Initial studies have demonstrated that the Kono-S anastomosis has prevented endoscopic evidence of the post-operative recurrence of Crohn's disease at greater rates than the traditional side-to-side functional end anastomosis. Follow up: Patients will be discharged on no prophylactic treatments and they will be followed post- operatively at 3 to 6 and 12 to 18 months with a colonoscopy to assess for endoscopic recurrence. The mucosa will be graded with the Rutgeerts score for post-operative recurrence. All colonoscopies are part of the standard treatment. All patients will have also standard 30 days follow up, 3 to 6 months, 12 months, and up to 60 months follow up. Follow up Care: Patients with a Rutgeerts score at 3 months of: 0, 1 or 2a will be followed prospectively without introducing medical treatment. above >2a will initiate medical therapy for Crohn's disease should the patient's symptoms warrant colonoscopic evaluation earlier than three months; this will be done at the gastroenterologist's discretion. This is a standard of care Colonoscopic images (still color photos acceptable) will be shown to a gastroenterologist blinded to the goal of the study for determination of the Rutgeerts score. Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will be recorded before procedure (baseline), 3 to 6 and 12-18 months, and at 60 months post procedure.

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