Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT03256240

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

Led by Weill Medical College of Cornell University · Updated on 2026-05-14

600

Participants Needed

15

Research Sites

1190 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

C

Crohn's and Colitis Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection
  • Age 18 years or older, male and female
  • All Crohn's disease types included: nonpenetrating (B1), stricturing (B2), and penetrating (B3) per Vienna classification
  • Patients may be on any medications prior to surgery, including anti-TNF therapy
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Patients with recurrent Crohn's disease
  • Pregnant patients
  • Patients with more than one non-contiguous site of active disease requiring multiple resections or bowel-sparing procedures
  • Patients with Crohn's disease extending to the cecum and ascending colon
  • Patients needing preventive postoperative medical treatment
  • Patients requiring a change of surgical procedure during intraoperative evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Terminated

2

Weill Cornell Medical College

New York, New York, United States, 10065

Actively Recruiting

3

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73112

Terminated

4

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75204

Terminated

5

Baylor College of Medicine

Houston, Texas, United States, 77030

Terminated

6

University of Washington Medical Center

Seattle, Washington, United States, 98195

Terminated

7

University Clinics Gasthuisberg Herestraat

Leuven, Belgium, 3000

Actively Recruiting

8

Helsinki University Hospital

Helsinki, Helsinki, Finland, 00029

Terminated

9

Universitätsklinik Würzburg

Würzburg, Wurzburg, Germany, D-97080

Actively Recruiting

10

Charité Campus Benjamin Franklin

Berlin, Germany, 12203

Actively Recruiting

11

Theresien Hospital and St. Hedwigs Clinic gGmbH

Mannheim, Germany, 68165

Actively Recruiting

12

Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, Italy, 50134

Actively Recruiting

13

Humanitas University Hospital

Rozzano, Milan, Italy, 20089

Actively Recruiting

14

Policlinico University Hospital

Naples, Italy

Actively Recruiting

15

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain, 08035

Terminated

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Research Team

K

Koianka Trencheva, Dr.PH,BSN,MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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