NCT04578392Terminated
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Reason given: PI left Cleveland Clinic
Brief summary (registry, in English)
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
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 1 Oct 2020
- Start date
- 28 Jul 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Crohn's disease
- NCT number
- NCT04578392
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing repeat ileocolic resection
- Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection.
- Clinically significant medical conditions within the six months before surgery: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
Other illness
- Patients with >30 cm of terminal ileal disease
- Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve
- Specific exclusions; Evidence of hepatitis B, C, or HIV
- History of cancer including melanoma (with the exception of localized skin cancers)
Age
- Patients less than 18 years of age
Other
- Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy
- Emergent indication for an operation
- Pregnant or breast feeding.
- Inability to follow up at respective sites for the primary endpoint
Who the study is looking for
- Males and females 18-65 years of age.
- Isolated ileocolic Crohn's disease of <30 cm in length
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
- Ability to comply with protocol
- Competent and able to provide written informed consent
- Medically refractory disease or inability to tolerate ongoing medical therapy
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mt. Sinai | Toronto | Canada | Unknown status |
| St Mark's Hospital and Academic Institution | Harrow | United Kingdom | Unknown status |
| Humanitas | Rozzano | Italy | Unknown status |
| Cleveland Clinic | Cleveland | United States | Unknown status |
| Cedars-Sinai Hospital System | Los Angeles | United States | Unknown status |
| Stanford University School of Medicine | Stanford | United States | Unknown status |
| Cleveland Clinic Florida | Weston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.