RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2014-03-12
Study Completion:2033-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03256240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
  2. 2. Age of 18 years and older, male and female
  3. 3. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
  4. 4. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.
  1. 1. Patients under 18 years of age
  2. 2. Patients with recurrent Crohn's
  3. 3. Pregnant patients
  4. 4. 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.
  5. 5. Patients with Crohn's disease extending to the cecum and ascending colon
  6. 6. Patients who will need preventive postoperative medical treatment
  7. 7. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

Contacts and Locations

Study Contact

Koianka Trencheva, Dr.PH,BSN,MS
CONTACT
646-962-2342
kivanova@med.cornell.edu

Principal Investigator

Fabrizio Michelassi, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Koianka Trencheva, Dr.PH,BSN,MS
STUDY_DIRECTOR
Weill Medical College of Cornell University

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Weill Cornell Medical College
New York, New York, 10065
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73112
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Fabrizio Michelassi, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
  • Koianka Trencheva, Dr.PH,BSN,MS, STUDY_DIRECTOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-03-12
Study Completion Date2033-12-31

Study Record Updates

Study Start Date2014-03-12
Study Completion Date2033-12-31

Terms related to this study

Keywords Provided by Researchers

  • Crohn's recurrence

Additional Relevant MeSH Terms

  • Crohn's Disease