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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 : August 1, 2018
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 21, 2017
Last Update Posted Date August 1, 2018
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03256240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
endoscopic remission [ Time Frame: 12 months ]
Endoscopic remission with a Rutgeert score at 12 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 16, 2017)
Harvey Bradshaw Index [ Time Frame: up to 12 months ]
marker of clinical disease activity
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
Official Title  ICMJE 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
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.
Detailed Description

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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Other: side-to-side functional end anastomosis
    type of anastomosis
  • Other: Kono-S analstomosis
    antimesenteric anastomosis
Study Arms  ICMJE
  • Active Comparator: side-to-side functional end anastomosis
    side-to-side functional end anastomosis creation
    Intervention: Other: side-to-side functional end anastomosis
  • Active Comparator: Kono-S
    antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
    Intervention: Other: Kono-S analstomosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2017)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Koiana Trencheva, BSN,M.S. 646-962-2342 kivanova@med.cornell.edu
Contact: Malinka Velcheva 646-962-2394 mav2022@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03256240
Other Study ID Numbers  ICMJE 1303013645
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE University of Washington
Investigators  ICMJE
Principal Investigator: Fabrizio Michelassi, MD Weill Medical College of Cornell University
Principal Investigator: Alessandro Fichera, MD University of Washington
PRS Account Weill Medical College of Cornell University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP