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
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Other: side-to-side functional end anastomosis Other: Kono-S analstomosis||Not Applicable|
- 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|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)|
|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|
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
- 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.
- 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.
- Number of subjects with surgical recurrence at 60 months [ Time Frame: 60 months ]
- Clinical disease activity measured by Harvey Bradshaw Index [ Time Frame: up to 60 months ]Harvey Bradshaw Index is a marker of clinical disease activity
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
|Contact: Koiana Trencheva, BSN,M.S.||firstname.lastname@example.org|
|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 email@example.com|
|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|
|University Clinics Gasthuisberg Herestraat||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Isabelle Terrasson +32 16 34 08 37 firstname.lastname@example.org|
|Contact: Andre D' Hoore, MD +32 16 34 08 37 email@example.com|
|Principal Investigator: Andre D' Hoore, MD|
|Helsinki University Hospital||Recruiting|
|Helsinki, Finland, 00029|
|Contact: Gisele Aaltonen, MD, PhD firstname.lastname@example.org|
|Theresien Hospital and St. Hedwigs Clinic gGmbH||Recruiting|
|Mannheim, Germany, 68165|
|Contact: Peter Kienle,, MD 0049621 / 424-4252, email@example.com|
|Contact: Kirsten Staiger (0621) 424-5809 K.Staiger@theresienkrankenhaus.de|
|Principal Investigator: Peter Kienle,, MD|
|Humanitas University Hospital||Recruiting|
|Rozzano, Milan, Italy, 20089|
|Contact: Annalisa Maroli, PhD 39 02 82247776 firstname.lastname@example.org|
|Contact: Antonino Spinelli, MD 39 02 82247776 email@example.com|
|Principal Investigator: Antonino Spinelli|
|Policlinico University Hospital||Recruiting|
|Contact: Gaetano Luglio, MD firstname.lastname@example.org|
|Contact: Francesca Tropeano email@example.com|
|Principal Investigator:||Fabrizio Michelassi, MD||Weill Medical College of Cornell University|