Prospective Randomized Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis in the Prevention of Post-operative Recurrence of Crohn's Disease

Weill Medical College of Cornell University

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 postoperative 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) 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-sid…

Eligibility

Age range: 18–90 years
Sex: All
Healthy volunteers: No

Detailed criteria

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-contiguou…

Interventions

Other
side-to-side functional end anastomosis
type of anastomosis
Other
Kono-S analstomosis
antimesenteric anastomosis

Locations (15)

Massachusetts General Hospital
Boston, Massachusetts
Weill Cornell Medical College
New York, New York
kivanova@med.cornell.edu 646-962-2342
University of Oklahoma
Oklahoma City, Oklahoma
Baylor Scott & White Research Institute
Dallas, Texas
Baylor College of Medicine
Houston, Texas
University of Washington Medical Center
Seattle, Washington