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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 month, 12-18 month and 60 month post-surgery endoscopy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in composition of the microbiome between treatment groups

Changes in the immune cell environment between treatment groups

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,215 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this trial at present?

"The information on clinicaltrials.gov indicates that this trial has ceased patient recruitment; the initial post was published on December 1st 2023 and last updated November 17th 2023. Fortunately, there are presently 269 other trials actively searching for participants to join their study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

2024. "Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06146335.

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