Recruiting

Kono-S vs. Side-to-side

Sponsor:

Weill Medical College of Cornell University

Code:

NCT03256240

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

side-to-side functional end anastomosis

Kono-S analstomosis

Study Details

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

Study ID

NCT03256240

Start date

Mar 12, 2014

Status verified date

May, 2026

Completion date

Dec 31, 2036

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

side-to-side functional end anastomosis

type of anastomosis

Kono-S analstomosis

antimesenteric anastomosis

Primary outcome measure

  • Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery [ Time Frame: 3-6 months after surgery ]
  • Number of subjects with surgical recurrence at 60 months [ Time Frame: 60 months after surgery ]
  • Number of subjects with surgical recurrence at 120 months [ Time Frame: 120 months after surgery ]
  • Mucosal Healing GHS [ Time Frame: 60 months after surgery ]
  • Mucosal Healing IBD-DCA [ Time Frame: 60 months after surgery ]
  • Surgical Pathology Margins [ Time Frame: at surgery ]

Central Contacts and Locations

Central contacts

Koianka Trencheva, Dr.PH,BSN,MS

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

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Koiana Ivanova Trencheva, BSN,M.S.

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

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Crohn's recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-14.