Comparing two surgical techniques for Crohn's disease
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
NA · The Cleveland Clinic · NCT04578392
This study is testing two different surgical methods for people with severe Crohn's disease to see which one helps reduce the chances of the disease coming back after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 181 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Drugs / interventions | vedolizumab, ustekinumab |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT04578392 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two surgical techniques for patients with medically refractory terminal ileal Crohn's disease: high ligation of the ileocolic artery versus mesenteric sparing ileocolic resection. Patients will be randomized based on their risk of post-operative recurrence, and the primary endpoint will be the rate of endoscopic recurrence at six months post-surgery. The study will also assess secondary endpoints at one and five years after the procedure. Conducted as a multicenter international study, it seeks to understand the role of the mesentery in disease recurrence following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with isolated ileocolic Crohn's disease less than 30 cm in length who have not responded to medical therapy.
Not a fit: Patients under 18, those with extensive disease or requiring additional surgical interventions, or those undergoing repeat ileocolic resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with Crohn's disease.
How similar studies have performed: Other studies have indicated the importance of surgical technique in managing Crohn's disease, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria:Inability to give informed consent. * Patients less than 18 years of age * 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. * 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 * Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy * 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. * Specific exclusions; Evidence of hepatitis B, C, or HIV * History of cancer including melanoma (with the exception of localized skin cancers) * Emergent indication for an operation * Pregnant or breast feeding. * History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity * Inability to follow up at respective sites for the primary endpoint
Where this trial is running
Los Angeles, California and 6 other locations
- Cedars-Sinai Hospital System — Los Angeles, California, United States (RECRUITING)
- Stanford University School of Medicine — Stanford, California, United States (RECRUITING)
- Cleveland Clinic Florida — Weston, Florida, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- Mt. Sinai — Toronto, Ontario, Canada (RECRUITING)
- Humanitas — Rozzano, Milano, Italy (RECRUITING)
- St Mark's Hospital and Academic Institution — Harrow, Middlesex, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Amy Lightner, MD — The Cleveland Clinic
- Study coordinator: Allison Bayles, AA
- Email: ibdstemcelltherapy@ccf.org
- Phone: 216-444-0887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, ileocolic resection, Crohn's disease