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Kono-S vs Side-to-Side Anastomosis for Crohn's Disease

N/A
Recruiting
Led By Fabrizio Michelassi, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection
Age of 18 years and older, male and female
Must not have
Patients with Crohn's disease extending to the cecum and ascending colon
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two types of surgery for Crohn's patients. The first type is the Kono-S anastomosis and the second is the standard side-to-side anastomosis.

Who is the study for?
Adults with any type of Crohn's disease needing initial surgery for ileitis or ileocolitis can join. They must be over 18 and can have had any treatment, including anti-TNF therapy. Not eligible if under 18, pregnant, have recurrent Crohn's, multiple active sites requiring more surgeries, disease extending to the cecum/ascending colon, or need a different surgery during operation.
What is being tested?
This study compares two surgical techniques in patients with Crohn's: Kono-S anastomosis versus side-to-side functional end anastomosis. It is randomized and prospective across multiple centers to see which method is better after resection in those with ileitis or ileocolitis.
What are the potential side effects?
Potential side effects are not specified but may include typical risks associated with intestinal surgery such as infection, bleeding, pain at the incision site, bowel obstruction due to scar tissue formation (adhesions), and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need surgery for my Crohn's affecting the ileum or both the ileum and colon.
Select...
I am 18 years old or older.
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I need surgery for my Crohn's affecting the ileum or both the ileum and colon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My Crohn's disease affects my cecum and ascending colon.
Select...
I need surgery in more than one area due to my disease spreading.
Select...
I am under 18 years old.
Select...
My Crohn's disease has come back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-18, 60, and 120 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-18, 60, and 120 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with surgical recurrence at 120 months
Number of subjects with surgical recurrence at 60 months
Post-operative remission of Crohn's disease between 3 and 6 months after surgery
Secondary study objectives
Clinical disease activity measured by Harvey Bradshaw Index
Focus Group
Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire for Crohn's disease(10 questions)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Kono-SActive Control1 Intervention
antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
Group II: side-to-side functional end anastomosisActive Control1 Intervention
side-to-side functional end anastomosis creation

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,346 Total Patients Enrolled
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
27,088 Total Patients Enrolled
Koianka Trencheva, Dr.PH,BSN,MSStudy DirectorWeill Medical College of Cornell University
Fabrizio Michelassi, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Kono-S analstomosis Clinical Trial Eligibility Overview. Trial Name: NCT03256240 — N/A
Crohn's Disease Research Study Groups: Kono-S, side-to-side functional end anastomosis
Crohn's Disease Clinical Trial 2023: Kono-S analstomosis Highlights & Side Effects. Trial Name: NCT03256240 — N/A
Kono-S analstomosis 2023 Treatment Timeline for Medical Study. Trial Name: NCT03256240 — N/A
~21 spots leftby Jul 2025
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