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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-18, 60, and 120 months after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-18, 60, and 120 months after surgery

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

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

Primary outcome measures

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 outcome measures

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,128 Total Patients Enrolled

Crohn's and Colitis FoundationOTHER

43 Previous Clinical Trials

27,497 Total Patients Enrolled

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

Frequently Asked Questions

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

How many centers are managing the execution of this clinical trial?

"Currently, 4 different medical sites are running this research project which can be found in Oklahoma City, New york and Dallas. Patients should select the most convenient clinic to them as a way of minimizing travel requirements if they choose to participate."

Answered by AI

Does this research trial accept participants below the age of 65?

"For this clinical trial, the acceptable age range for participants is over 18 years but under 90 years."

Answered by AI

What is the capacity of this research project?

"Affirmative. Clinicaltrials.gov's information suggests that this research trial is currently recruiting for 88 participants from 4 different medical locations since its first post on March 12th 2014, and most recently updated on March 24th 2022."

Answered by AI

Will I qualify to partake in this trial?

"Patients aged between 18 and 90 who suffer from ileocolitis can submit their application to this clinical trial, which is seeking a total of 88 participants."

Answered by AI

Have any new participants been enrolled in this research project recently?

"According to the latest clinicaltrials.gov data, this trial is open for enrolment and has been since March 12th 2014 (with a most recent update on March 24th 2022)."

Answered by AI

Recent research and studies

Colorectal DiseaseJournal

Kono-s Anastomosis for Crohn's Disease: Narrative - a Video Vignette

Kono, T., and A. Fichera. 2014. “Kono-s Anastomosis for Crohn's Disease: Narrative - a Video Vignette”. Colorectal Disease. Wiley. doi:10.1111/codi.12722.

Diseases of the Colon & RectumJournal

A New Antimesenteric Functional End-to-end Handsewn Anastomosis: Surgical Prevention of Anastomotic Recurrence in Crohn's Disease

Kono, Toru, Toshifumi Ashida, Yoshiaki Ebisawa, Naoyuki Chisato, Kotaro Okamoto, Hidetoshi Katsuno, Kotaro Maeda, Mikihiro Fujiya, Yutaka Kohgo, and Hiroyuki Furukawa. 2011. “A New Antimesenteric Functional End-to-end Handsewn Anastomosis: Surgical Prevention of Anastomotic Recurrence in Crohn's Disease”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/dcr.0b013e318208b90f.

clinicaltrials.govStudy

Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis

2014. "Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03256240.