An interventional study of side-to-side functional end anastomosis and Kono-S analstomosis in Crohn's Disease, sponsored by Weill Medical College of Cornell University. Recruiting at 15 sites in 6 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention
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.
Study Aim:
Methods
Design: This will be a multi-center randomized prospective trial with 500 subjects. 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 (control group).
The purpose of this study is to compare the postoperative recurrence of Crohn's disease between the Kono-S procedure and the side-to-side functional end anastomosis and to evaluate the surgical recurrence rate at 60 and 120 months between the groups.
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 of 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, 12 to 18, 60-, and 120 months with a colonoscopy to assess for endoscopic recurrence. The mucosa will be graded with the modified Rutgeerts score for postoperative recurrence. All colonoscopies are part of the standard treatment. All patients will have also standard 30 days, 3 to 6, 12 to 18, 24, 36-, 48-, 60-, 72-, 84-, 96-, 108-, and 120 months follow-ups by phone call, through medical records, or during the postoperative clinic visit.
Follow-up Care: Patients with a Rutgeerts score at 3-to-6 months of:
Exclusion Criteria:
side-to-side functional end anastomosis creation
Other: side-to-side functional end anastomosis
antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
Other: Kono-S analstomosis
type of anastomosis
antimesenteric anastomosis
Post-operative endoscopic remission of Crohn's disease between 3 and 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.
Time frame: 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.
Time frame: 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.
Time frame: 120 months after surgery
Mucosal Healing GHS
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).
Time frame: 60 months after surgery
Mucosal Healing IBD-DCA
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
Time frame: 60 months after surgery
Surgical Pathology Margins
Histological evaluation of the surgical pathology margin evaluation for presence or absence of disease
Time frame: at surgery
Post-operative endoscopic remission of Crohn's disease between 12 and 18 months, at 60-, and 120 months after surgery
Endoscopic remission with a modified Rutgeerts score at 12 to 18, 60-, and 120 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. An endoscopic Rutgeerts score of 2b or higher will be considered a recurrence.
Time frame: 12-18, 60, and 120 months after surgery
Work Productivity and Activity Impairment (WPAI) due to Crohn's disease
Work Productivity and Activity Impairment (WPAI) is a validated 6-item questionnaire that measures the amount of absenteeism and presenteeism due to CD during and activity impairment the 7 days prior to administration. It consists of 6 questions with the following domains: 1) employment status; 2) hours missed due to CD; 3) hours missed due to other reasons; 4) hours actually worked; 5) the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and 6) the degree to which CD affected regular activities from 0 (no effect) to 10 maximum impairment ). All six question' domains will be reported and compared between the groups. Between the groups and within patients, changes will be evaluated. The mean score annual variability in each domain will be evaluated.
Time frame: up to 120 months
Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire for Crohn's disease(10 questions)
Validated questionnaire to evaluate the quality of life in IBD patients. The short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item shortened version of the original IBDQ, which was 32 items. Measures quality of life as measured in four domains, bowel symptoms, emotional health, systemic systems, and social function. SIBDQ score ranges between 10 and 70 points. QUOL is considered to be slightly (60-70 points), moderately (45-60 points), or severely impaired (10-45 points). In our study, the cut-off for relevant impairment of QUOL \< 60 points.
Time frame: up to 120 months
Clinical disease activity measured by Harvey Bradshaw Index
Harvey Bradshaw Index is a marker of clinical disease activity. The following score grading system will be used to determine the clinical disease activity: Remission \< 5 Mild disease 5-7 Moderate disease 8-16 Severe disease \>16
Time frame: up to 120 months
Time to surgical recurrence between Group1 and Group2
Time to surgical recurrence between Group1 and Group2 measured in months from the index surgery
Time frame: up to 120 months
Focus Group
Patient Focus Groups from national and international study sites to evaluate patient's perspectives on surgical treatment, patients' goals of surgical treatment, and surgical treatment's personal and social impacts, patient perspective on nutrition, long-term psychosocial impact and nutrition challenges, and caregiver perspective on surgical treatment.
Time frame: up to 120 months
Medication therapy type
Medication therapy for Crohn's disease after the index surgery. We will monitor the type of medications patients receive after surgery. The following five types of medications will be recorded: Biologics, Immunosuppressants, Corticosteroids, Anti-Inflammatory, and Antibiotics.
Time frame: up to 120 months
Readmission rates between Group1 and Group2
Number of readmission due to Crohn's disease after the index surgery
Time frame: up to 120 months
Mortality rate
Number of patient expired after the index surgery
Time frame: up to 120 months
The Brief Illness Perception Questionnaire
The Brief Illness Perception Questionnaire, (a 9-item questionnaire) score with the nine items rated on a scale from 0 (minimum) to 10 (maximum), with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores of all eight items, with a possible range of 0-80. Higher scores indicate worse illness perception.
Time frame: up to 120 months
Postoperative Morbidity
Postoperative morbidity is defined as any deviation from the normal postoperative recovery course occurring within 30 days after surgery, as documented in daily in-hospital checks, clinical documentation records, imaging, laboratory results, interventional notes, or surgeon assessment, and presented as a binary outcome- "Yes" or "No".
Time frame: within 30 days after surgery
Postoperative Morbidity
Postoperative morbidity is defined as any deviation from the normal postoperative recovery course occurring up to 120 months after surgery, as documented in daily in-hospital checks, clinical documentation records, imaging, laboratory results, interventional notes, or surgeon assessment, and presented as a binary outcome- "Yes" or "No".
Time frame: up to 120 months
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Weill Medical College of Cornell University