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

Who is this study for? Adult patients with Crohn's Disease
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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 anti- tumor necrosis factor(TNF) therapy.

Locations
United States
Massachusetts
Massachusetts General Hospital
TERMINATED
Boston
New York
Weill Cornell Medical College
RECRUITING
New York
Oklahoma
University of Oklahoma
TERMINATED
Oklahoma City
Texas
Baylor Scott & White Research Institute
TERMINATED
Dallas
Baylor College of Medicine
TERMINATED
Houston
Washington
University of Washington Medical Center
TERMINATED
Seattle
Other Locations
Belgium
University Clinics Gasthuisberg Herestraat
RECRUITING
Leuven
Finland
Helsinki University Hospital
TERMINATED
Helsinki
Germany
Charité Campus Benjamin Franklin
RECRUITING
Berlin
Theresien Hospital and St. Hedwigs Clinic gGmbH
RECRUITING
Mannheim
Universitätsklinik Würzburg
RECRUITING
Würzburg
Italy
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Policlinico University Hospital
RECRUITING
Naples
Humanitas University Hospital
RECRUITING
Rozzano
Spain
Hospital Universitario Vall d'Hebron
TERMINATED
Barcelona
Contact Information
Primary
Koianka Trencheva, Dr.PH,BSN,MS
kivanova@med.cornell.edu
646-962-2342
Time Frame
Start Date: 2014-03-12
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 550
Treatments
Active_comparator: side-to-side functional end anastomosis
side-to-side functional end anastomosis creation
Active_comparator: Kono-S
antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: Crohn's and Colitis Foundation

This content was sourced from clinicaltrials.gov

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