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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    88
  • sponsor
    Weill Medical College of Cornell University
Updated on 14 April 2022
tumor necrosis factor
tumor necrosis factor alpha
tumour necrosis
ileitis
ileocolitis

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.

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 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.

Details
Condition Crohn's Disease
Treatment side-to-side functional end anastomosis, Kono-S analstomosis
Clinical Study IdentifierNCT03256240
SponsorWeill Medical College of Cornell University
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection
Age of 18 years and older, male and female
All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
The patients can be on any medications coming into surgery, including prior antitumor necrosis factor(TNF) therapy

Exclusion Criteria

Patients under 18 years of age
Patients with recurrent Crohn's
Pregnant patients
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
Patients with Crohn's disease extending to the cecum and ascending colon
Patients who will need preventive postoperative medical treatment
Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation
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