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

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ClinicalTrials.gov Identifier: NCT03256240
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : March 16, 2021
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Other: side-to-side functional end anastomosis Other: Kono-S analstomosis Not Applicable

Detailed Description:

Study Aim:

  • The primary aim of this study is to compare the post-operative recurrence of CD using the Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and side-to-side functional end anastomosis (Group2).
  • The secondary aim is to evaluate the post-operative recurrence of CD using the Rutgeerts score at 12-18 months, surgical recurrence rate at 60 months between the groups.

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. 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.

Follow up: Patients will be discharged on no prophylactic treatments and they will be followed post- operatively at 3 to 6 and 12 to 18 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, 3 to 6 months, 12 months, and up to 60 months 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 (still color photos acceptable) will be shown to a gastroenterologist blinded to the goal of the study for determination of the Rutgeerts score.

Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will be recorded before procedure (baseline), 3 to 6 and 12-18 months, and at 60 months post procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 12, 2014
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Active Comparator: side-to-side functional end anastomosis
side-to-side functional end anastomosis creation
Other: side-to-side functional end anastomosis
type of anastomosis

Active Comparator: Kono-S
antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
Other: Kono-S analstomosis
antimesenteric anastomosis




Primary Outcome Measures :
  1. Post-operative remission of Crohn's disease between 3 and 6 months after surgery [ Time Frame: 3-6 months after surgery ]
    Endoscopic remission with a Rutgeert score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis.


Secondary Outcome Measures :
  1. Post-operative remission of Crohn's disease between 12 and 18 months after surgery [ Time Frame: 12-18 months after surgery ]
    Endoscopic remission with a Rutgeert score at 12 to 18 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis.

  2. Number of subjects with surgical recurrence at 60 months [ Time Frame: 60 months ]

Other Outcome Measures:
  1. Clinical disease activity measured by Harvey Bradshaw Index [ Time Frame: up to 60 months ]
    Harvey Bradshaw Index is a marker of clinical disease activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256240


Contacts
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Contact: Koiana Trencheva, BSN,M.S. 646-962-2342 kivanova@med.cornell.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Terminated
Boston, Massachusetts, United States, 02114
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Koiana Ivanova Trencheva, BSN,M.S.    646-962-2342    kivanova@med.cornell.edu   
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75204
Contact: Katerina Wells, MD         
Contact: Katalin Martits-Chalangari, MD       KATALIN.MARTITSCHALANGARI@BSWHealth.org   
United States, Washington
University of Washington Medical Center Terminated
Seattle, Washington, United States, 98195
Belgium
University Clinics Gasthuisberg Herestraat Recruiting
Leuven, Belgium, 3000
Contact: Isabelle Terrasson    +32 16 34 08 37    isabelle.terrasson@uzleuven.be   
Contact: Andre D' Hoore, MD    +32 16 34 08 37    andre.dhoore@uzleuven.be   
Principal Investigator: Andre D' Hoore, MD         
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Gisele Aaltonen, MD, PhD       gisele.aaltonen@helsinki.fi   
Germany
Theresien Hospital and St. Hedwigs Clinic gGmbH Recruiting
Mannheim, Germany, 68165
Contact: Peter Kienle,, MD    0049621 / 424-4252,    p.kienle@theresienkrankenhaus.de   
Contact: Kirsten Staiger    (0621) 424-5809    K.Staiger@theresienkrankenhaus.de   
Principal Investigator: Peter Kienle,, MD         
Italy
Humanitas University Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Annalisa Maroli, PhD    39 02 82247776    annalisa.maroli@cancercenter.humanitas.it   
Contact: Antonino Spinelli, MD    39 02 82247776    antonino.spinelli@hunimed.eu   
Principal Investigator: Antonino Spinelli         
Policlinico University Hospital Recruiting
Naples, Italy
Contact: Gaetano Luglio, MD       gaetano.luglio@unina.it   
Contact: Francesca Tropeano       fpt.tropeano@gmail.com   
Sponsors and Collaborators
Weill Medical College of Cornell University
Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Fabrizio Michelassi, MD Weill Medical College of Cornell University
Publications:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03256240    
Other Study ID Numbers: 1303013645
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Crohn's recurrence
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases