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NCT03256240 · ClinicalTrials.gov registry record · NA
Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
A NA study of Crohn's Disease, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- NA
- Development phase
- 600
- Enrollment target
- 15
- Study locations
NCT03256240: Recruiting NA study of Crohn's Disease, sponsored by Weill Medical College of Cornell University.
NCT03256240 is a NA study of Crohn's Disease that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 600 participants, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (75% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03256240, a NA study of Crohn's Disease, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study proposes a randomized prospective study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.
Primary Outcome
Endoscopic remission with a modified Rutgeerts score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. Endoscopic remission is defined as a modified Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.
Conditions Studied
Interventions
- OTHER side-to-side functional end anastomosis
- OTHER Kono-S analstomosis
Study Locations (15)
Other
- University Clinics Gasthuisberg Herestraat - Leuven
- Charité Campus Benjamin Franklin - Berlin
- Theresien Hospital and St. Hedwigs Clinic gGmbH - Mannheim
- Policlinico University Hospital - Naples
Texas
- Baylor Scott & White Research Institute - Dallas
- Baylor College of Medicine - Houston
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Weill Cornell Medical College - New York
Oklahoma
- University of Oklahoma - Oklahoma City
Washington
- University of Washington Medical Center - Seattle
Helsinki
- Helsinki University Hospital - Helsinki
Wurzburg
- Universitätsklinik Würzburg - Würzburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2014-03-12 |
| Est. Completion | 2033-12-31 |
| Phase | NA |
What NCT03256240 shows while recruiting
NCT03256240 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which side-to-side functional end anastomosis is the first listed.
NCT03256240 lists 15 locations in 11 states (Other, Texas, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03256240 about?
NCT03256240 is a clinical study titled "Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis". This study proposes a randomized prospective study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomized prospective trial. Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized to undergo either the Kon...
What is the current status of trial NCT03256240?
This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2014-03-12. Estimated completion is 2033-12-31.
What conditions does trial NCT03256240 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT03256240?
The interventions under investigation include: side-to-side functional end anastomosis (OTHER), Kono-S analstomosis (OTHER).
Who is sponsoring clinical trial NCT03256240?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03256240 being conducted?
This trial has 15 study locations across Massachusetts, New York, Oklahoma, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03256240's enrollment target sits among peer trials
600 22nd of 105 higher than 84 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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