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NCT04578392 · ClinicalTrials.gov registry record · NA
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
A NA study of Crohn Disease, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 181
- Enrollment target
- 7
- Study locations
NCT04578392: Recruiting NA study of Crohn Disease, sponsored by The Cleveland Clinic.
NCT04578392 is a NA study of Crohn Disease that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 181 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (11% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04578392, a NA study of Crohn Disease, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 181 participants
- Enrollment target
- 7
- Study locations
Study Summary
Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years
Primary Outcome
Endoscopic recurrence is define as a Rutgeert score \>2 at the time of colonoscopy The score is attributed directly, by selecting the appropriate degree - 5 degrees, from i0 (lowest) to i4 highest, with single-choice selection menu. Rutgeerts score is only be used for evaluation of post-surgical recurrences at ileocolic anastomosis level.
Conditions Studied
Interventions
- PROCEDURE high ligation of ileocolic artery
- PROCEDURE mesenteric sparing
Study Locations (7)
California
- Cedars-Sinai Hospital System - Los Angeles
- Stanford University School of Medicine - Stanford
Florida
- Cleveland Clinic Florida - Weston
Ohio
- Cleveland Clinic - Cleveland
Ontario
- Mt. Sinai - Toronto
Milano
- Humanitas - Rozzano
Middlesex
- St Mark's Hospital and Academic Institution - Harrow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT04578392 shows while recruiting
NCT04578392 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which high ligation of ileocolic artery is the first listed.
NCT04578392 lists 7 locations in 6 states (California, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT04578392 about?
NCT04578392 is a clinical study titled "MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)". Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6...
What is the current status of trial NCT04578392?
This trial is currently recruiting. It is a NA study. The enrollment target is 181 participants. The study started on 2020-07-28. Estimated completion is 2027-12-31.
What conditions does trial NCT04578392 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT04578392?
The interventions under investigation include: high ligation of ileocolic artery (PROCEDURE), mesenteric sparing (PROCEDURE).
Who is sponsoring clinical trial NCT04578392?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04578392 being conducted?
This trial has 7 study locations across California, Florida, Ohio, Ontario, Milano. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04578392's enrollment target sits among peer trials
181 22nd of 71 higher than 50 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn 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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