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

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.

Conditions

Crohn's Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

New York

Weill Cornell Medical College, New York, New York, United States, 10065

Oklahoma City

University of Oklahoma, Oklahoma City, Oklahoma, United States, 73112

Dallas

Baylor Scott & White Research Institute, Dallas, Texas, United States, 75204

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Seattle

University of Washington Medical Center, Seattle, Washington, United States, 98195

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 1. Patients under 18 years of age
  • 2. Patients with recurrent Crohn's
  • 3. Pregnant patients
  • 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. Patients with Crohn's disease extending to the cecum and ascending colon
  • 6. Patients who will need preventive postoperative medical treatment
  • 7. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2033-12-31