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

Aim of the study:

To compare the post-operative recurrence of Crohn's disease using Rutgeert score at three
months between Kono-S procedure and the side-to-side functional end anastomosis.

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. There is no evidence which of these
commonly-used treatments is better because more information is needed. The purpose of this
study is to find this by doing this study.

Follow up: Patients will be discharged on no prophylactic treatments and they will be
followed post- operatively at 3to 6 and 12 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.

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 (movie preferable, still color photos acceptable) will be shown to a
gastroenterologist blinded to the goal of the study for determination of the Rutgeerts score.
The patients will then undergo a subsequent colonoscopy at one year from surgery for
reassessment of the anastomosis.

Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will be
recorded before procedure (baseline), 3to 6 and 12 months post procedure.

Inclusion Criteria:

1. Patients with Crohn's ileitis or ileocolitis age 18 or older requiring surgical
resection.

nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according
to the Vienna classification)

2. 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 pregnant patients and 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.

3. Subjects who do not speak English