What this study is
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.
What's being tested
- side-to-side functional end anastomosis
Intervention · OTHER
type of anastomosis
- Kono-S analstomosis
Intervention · OTHER
antimesenteric anastomosis
Study details
- Official title
- 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
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Crohn's Disease
- Enrolling
- 600 people
- Starts
- 2014-03-12
- Est. completion
- 2036-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (15)
8 openWeill Cornell Medical College
New York, New York, United States
- Koiana Ivanova Trencheva, BSN,M.S. · Contact646-962-2342kivanova@med.cornell.edu
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
TerminatedUniversity of Oklahoma
Oklahoma City, Oklahoma, United States
TerminatedBaylor Scott & White Research Institute
Dallas, Texas, United States
TerminatedBaylor College of Medicine
Houston, Texas, United States
TerminatedUniversity of Washington Medical Center
Seattle, Washington, United States
Terminated
9 sites outside the US
University Clinics Gasthuisberg Herestraat
Leuven, Belgium
- Isabelle Terrasson · Contact+32 16 34 08 37isabelle.terrasson@uzleuven.be
- Andre D' Hoore, MD · Contact+32 16 34 08 37andre.dhoore@uzleuven.be
- Andre D' Hoore, MD · Principal investigator
RecruitingUniversitätsklinik Würzburg
Würzburg, Wurzburg, Germany
- Sven Flemming, MD · ContactFlemming_S@ukw.de
- Sven Flemming, MD · Principal investigator
RecruitingCharité Campus Benjamin Franklin
Berlin, Germany
- Swantje Malinka, MD · Contactswantje.malinka@charite.de
- Richard Mertens, MD · Contactrichard.mertens@charite.de
RecruitingTheresien Hospital and St. Hedwigs Clinic gGmbH
Mannheim, Germany
- Peter Kienle,, MD · Contact0049621 / 424-4252,p.kienle@theresienkrankenhaus.de
- Kirsten Staiger · Contact(0621) 424-5809K.Staiger@theresienkrankenhaus.de
- Peter Kienle,, MD · Principal investigator
RecruitingAzienda Ospedaliero-Universitaria Careggi
Florence, Florence, Italy
- Stefano Scaringi, MD · Contactstefano.scaringi@unifi.it
- Stefano Scaringi, MD · Principal investigator
RecruitingHumanitas University Hospital
Rozzano, Milan, Italy
- Annalisa Maroli, PhD · Contact39 02 82247776annalisa.maroli@cancercenter.humanitas.it
- Antonino Spinelli, MD · Contact39 02 82247776antonino.spinelli@hunimed.eu
- Antonino Spinelli · Principal investigator
RecruitingPoliclinico University Hospital
Naples, Italy
- Gaetano Luglio, MD · Contactgaetano.luglio@unina.it
- Francesca Tropeano · Contactfpt.tropeano@gmail.com
RecruitingHelsinki University Hospital
Helsinki, Helsinki, Finland
TerminatedHospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain
Terminated
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 1303013645
Principal investigator
Fabrizio Michelassi, MD
Weill Medical College of Cornell University
Principal investigator
Koianka Trencheva, Dr.PH,BSN,MS
Weill Medical College of Cornell University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.