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Procedure

Surgical Techniques for Crohn's Disease

N/A
Waitlist Available
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/ileocolitis requiring surgical resection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 month, 12-18 month and 60 month post-surgery endoscopy.
Awards & highlights
No Placebo-Only Group

Summary

This trial compares how 2 gut surgery procedures affect bacteria & immune system in the gut, hypothesizing differences.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated, potential side effects may include typical risks associated with intestinal surgery such as infection, bleeding, pain at the incision site, and complications related to bowel function.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 month, 12-18 month and 60 month post-surgery endoscopy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 month, 12-18 month and 60 month post-surgery endoscopy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in composition of the microbiome between treatment groups
Changes in the immune cell environment between treatment groups

Awards & Highlights

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

Trial Design

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 Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,085 Previous Clinical Trials
1,147,242 Total Patients Enrolled
Crohn's & Colitis Foundation of America, Inc.UNKNOWN
Fabrizio Michelassi, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
400 Total Patients Enrolled
~53 spots leftby Dec 2033
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