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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with Crohn's ileitis or ileocolitis age 18 or older requiring surgical resection. nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification) 2. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.

Exclusion Criteria:

1. Patients under 18 years of age 2. Patients with recurrent Crohn's pregnant patients and 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. 3. Subjects who do not speak English

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03256240
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Fabrizio Michelassi, MD
Principal Investigator Affiliation Weill Medical College of Cornell University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOtherOtherOther
Overall Status Recruiting
Countries Belgium, Germany, Italy, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

Aim of the study: To compare the post-operative recurrence of Crohn's disease using Rutgeert score at three months between Kono-S procedure and the side-to-side functional end anastomosis. Methods Design: This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring initial resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis. Patients will be randomized into two Groups: Group 1: Kono-S anastomosis vs.#46; Group 2: side-to-side functional end anastomosis. The purpose of this study is to compare the post-operative recurrence of Crohn's disease between Kono-S procedure and the side-to-side functional end anastomosis. In any intestine surgery, after the sick portion of the bowel is removed, the intestinal tract is restored by reconnecting the healthy ends together. The new connecting line is called anastomosis, and could be created in a variety ways by the surgeon. This study will compare two different intestinal connections called Kono-S anastomosis and the traditional side-to-side functional end anastomosis. Initial studies have demonstrated that the Kono-S anastomosis has prevented endoscopic evidence of the post-operative recurrence of Crohn's disease at greater rates than the traditional side-to-side functional end anastomosis. There is no evidence which of these commonly-used treatments is better because more information is needed. The purpose of this study is to find this by doing this study. Follow up: Patients will be discharged on no prophylactic treatments and they will be followed post- operatively at 3to 6 and 12 months with a colonoscopy to assess for endoscopic recurrence. The mucosa will be graded with the Rutgeerts score for post-operative recurrence. All colonoscopies are part of the standard treatment. All patients will have also standard 30 days follow up. Follow up Care: Patients with a Rutgeerts score at 3 months of:

  • - 0, 1 or 2a will be followed prospectively without introducing medical treatment.
  • - above >2a will initiate medical therapy for Crohn's disease - should the patient's symptoms warrant colonoscopic evaluation earlier than three months; this will be done at the gastroenterologist's discretion.
This is a standard of care Colonoscopic images (movie preferable, still color photos acceptable) will be shown to a gastroenterologist blinded to the goal of the study for determination of the Rutgeerts score. The patients will then undergo a subsequent colonoscopy at one year from surgery for reassessment of the anastomosis. Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will be recorded before procedure (baseline), 3to 6 and 12 months post procedure.

Arms & Interventions

Arms

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

Interventions

Other: - side-to-side functional end anastomosis

type of anastomosis

Other: - Kono-S analstomosis

antimesenteric anastomosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Caitlin Stafford

CSTAFFORD2@PARTNERS.ORG

617-643-7869

Weill Cornell Medical College, New York, New York

Status

Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

Site Contact

Koiana Ivanova Trencheva, BSN,M.S.

kivanova@med.cornell.edu

646-962-2342

University of Washington Medical Center, Seattle, Washington

Status

Terminated

Address

University of Washington Medical Center

Seattle, Washington, 98195

International Sites

Leuven, Belgium

Status

Recruiting

Address

University Clinics Gasthuisberg Herestraat

Leuven, , 3000

Site Contact

Isabelle Terrasson

isabelle.terrasson@uzleuven.be

+32 16 34 08 37

Mannheim, Germany

Status

Recruiting

Address

Theresien Hospital and St. Hedwigs Clinic gGmbH

Mannheim, , 68165

Site Contact

Peter Kienle,, MD

p.kienle@theresienkrankenhaus.de

0049621 / 424-4252,

Humanitas University Hospital, Rozzano, Milan, Italy

Status

Not yet recruiting

Address

Humanitas University Hospital

Rozzano, Milan, 20089

Site Contact

Annalisa Maroli, PhD

annalisa.maroli@cancercenter.humanitas.it

39 02 82247776

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