Overseen byFabrizio Michelassi, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Weill Medical College of Cornell University
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.
Eligibility Criteria
This trial is for adults with Crohn's ileitis or ileocolitis who need surgery. It includes those previously in a related trial and all disease types (B1, B2, B3). Patients on any preoperative medication are eligible.Inclusion Criteria
I need surgery for my Crohn's affecting the ileum or ileum and colon.
Treatment Details
The study compares two surgical techniques for Crohn's Disease: Kono-S anastomosis (KSa) and side-to-side anastomosis (SSa), focusing on their effects on gut bacteria and the immune system within the intestines.
2Treatment groups
Experimental Treatment
Active Control
Group I: Kono-S anastomosis (KSa)Experimental Treatment1 Intervention
Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis
Group II: side-to-side anastomosis (SSa)Active Control1 Intervention
Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis
Find a clinic near you
Research locations nearbySelect from list below to view details:
Weill Cornell Medical CenterNew York, NY
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
Crohn's & Colitis Foundation of America, Inc.Collaborator