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

NCT03256240 | Recruiting

• 1 other identifier: 1303013645
• Study Type: interventional
• Target: 600
• Locations: 6 countries
• Sites: 15

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.

Conditions

Crohn's Disease

Keywords

Crohn's recurrence

Outcome Measures

Primary Outcomes (3)

• Post-operative remission of Crohn's disease between 3 and 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. Endoscopic remission is defined as a Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.

  3-6 months after surgery

• Number of subjects with surgical recurrence at 60 months

  Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.

  60 months after surgery

• Number of subjects with surgical recurrence at 120 months

  Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.

  120 months after surgery

Secondary Outcomes (13)

• Post-operative remission of Crohn's disease between 12 and 18 months, at 60-, and 120 months after surgery

  12-18, 60, and 120 months after surgery

• Work Productivity and Activity Impairment (WPAI) due to Crohn's disease

  up to 120 months

• Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire for Crohn's disease(10 questions)

  up to 120 months

• Clinical disease activity measured by Harvey Bradshaw Index

  up to 120 months

• Time to surgical recurrence between Group1 and Group2

  up to 120 months

Study Arms (2)

side-to-side functional end anastomosis

ACTIVE COMPARATOR

side-to-side functional end anastomosis creation

Other: side-to-side functional end anastomosis

Kono-S

ACTIVE COMPARATOR

antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis

Other: Kono-S analstomosis

Interventions

side-to-side functional end anastomosis OTHER

type of anastomosis

side-to-side functional end anastomosis

Kono-S analstomosis OTHER

antimesenteric anastomosis

Kono-S

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
• Age of 18 years and older, male and female
• All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
• The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (15)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

TERMINATED

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73112, United States

TERMINATED

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

TERMINATED

Baylor College of Medicine

Houston, Texas, 77030, United States

TERMINATED

University of Washington Medical Center

Seattle, Washington, 98195, United States

TERMINATED

University Clinics Gasthuisberg Herestraat

Leuven, 3000, Belgium

RECRUITING

Helsinki University Hospital

Helsinki, Helsinki, 00029, Finland

TERMINATED

Universitätsklinik Würzburg

Würzburg, Wurzburg, D-97080, Germany

RECRUITING

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Theresien Hospital and St. Hedwigs Clinic gGmbH

Mannheim, 68165, Germany

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, 50134, Italy

RECRUITING

Humanitas University Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Policlinico University Hospital

Naples, Italy

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

TERMINATED

Related Publications (2)

• Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.

  PMID: 21471760 BACKGROUND

• Kono T, Fichera A. Kono-S anastomosis for Crohn's disease: narrative - a video vignette. Colorectal Dis. 2014 Oct;16(10):833. doi: 10.1111/codi.12722. No abstract available.

  PMID: 25040294 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Fabrizio Michelassi, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Koianka Trencheva, Dr.PH,BSN,MS

  Weill Medical College of Cornell University

  STUDY DIRECTOR

Central Study Contacts

Koianka Trencheva, Dr.PH,BSN,MS

CONTACT

646-962-2342; kivanova@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 21, 2017
• Study Start: March 12, 2014
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): December 31, 2033
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

DE (3); IT (3); FI (1); BE (1); US (6); ES (1)