Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis (NCT03256240) | Clinical Trial Compass
RecruitingNot Applicable
Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
United States, Belgium, Finland600 participantsStarted 2014-03-12
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Patients under 18 years of age
. Patients with recurrent Crohn's
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery
Timeframe: 3-6 months after surgery
2
Number of subjects with surgical recurrence at 60 months
Timeframe: 60 months after surgery
3
Number of subjects with surgical recurrence at 120 months
Timeframe: 120 months after surgery
4
Mucosal Healing GHS
Timeframe: 60 months after surgery
5
Mucosal Healing IBD-DCA
Timeframe: 60 months after surgery
6
Surgical Pathology Margins
Timeframe: at surgery
Trial details
NCT IDNCT03256240
SponsorWeill Medical College of Cornell University
. 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.