NCT03256240 · Weill Medical College of Cornell University
Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
What this study is about
This study proposes a randomly assigned forward-looking study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomly assigned forward-looking trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomly assigned to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.
View original scientific description
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.
Interventions
OTHER
side-to-side functional end anastomosis
type of anastomosis
OTHER
Kono-S analstomosis
antimesenteric anastomosis
Primary outcome measures
Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery
Time frame: 3-6 months after surgery
Endoscopic remission with a modified Rutgeerts 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 modified Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.
Number of subjects with surgical recurrence at 60 months
Time frame: 60 months after surgery
Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
Number of subjects with surgical recurrence at 120 months
Time frame: 120 months after surgery
Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
Mucosal Healing GHS
Time frame: 60 months after surgery
Mucosal Healing from colonoscopy biopsies using the modified Global Histology Activity Score (Modified) score between the groups. Global Histology Activity Score (GHAS) is a widely used tool that grades biopsies of the ileum and colonic segments. The score has 8 domains and includes the presence of architectural changes, degree of chronic, neutrophilic and eosinophilic inflammatory infiltration in lamina propria, presence of intraepithelial neutrophils, epithelial damage, mucosal defects, presence of granulomas, and the extent of inflammation (proportion of biopsy specimens affected). Each domain is scored independently, and the total score is the sum of all individual scores, ranging from 2 (being the lowest meaning no histological activity) to 16 (being the highest meaning high histological disease activity).
Mucosal Healing IBD-DCA
Time frame: 60 months after surgery
Mucosal Healing from colonoscopy biopsies using The Inflammatory Bowel Disease-Distribution, Chronicity, Activity \[IBD-DCA\] score between the groups. The score is validated and has 3 domains: 1) Distribution of the disease; 2) Chronicity of the disease; and 3) Activity of the disease. Each domain of the IBD-DCA is scored as one of 0 (normal), 1 (mild), or 2 (moderate to severe) based on the presence of established histological findings and the domains are separately reported. Distribution \[D\] 0=Normal 1. \< 50% of tissue affected per same biopsy site 2. ≥ 50% of tissue affected per same biopsy site Chronic features \[C\] 0=Normal 1=Crypt distortion and/or mild lymphoplasmacytosis 2=Marked lymphoplasmacytosis and/or marked basal plasmacytosis Activity features \[A\] 0=Normal 1. Two or more neutrophils in lamina propria in one high-power field \[HPF\] and/or intraepithelial neutrophils \[any number\] 2. Crypt abscesses, erosions, ulcers
Surgical Pathology Margins
Time frame: at surgery
Histological evaluation of the surgical pathology margin evaluation for presence or absence of disease
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Boston, Massachusetts
- New York, New York
- Oklahoma City, Oklahoma
- Dallas, Texas
- Houston, Texas
- Seattle, Washington
Collaborators
Crohn's and Colitis Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations