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NCT04578392: SPARES
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
NA trial testing high ligation of ileocolic artery in Crohn Disease in 13 participants. Terminated before completion.
31 December 2023
Quick facts
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 28 July 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 7 locations across Italy, Canada, United States, United Kingdom |
Drugs / interventions tested
- high ligation of ileocolic artery
- mesenteric sparing
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
Sponsor
The Cleveland Clinic
Who can join
Adults 18 to 65, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Management of Post-Operative Crohn's Disease: Knowns and Unknowns.
Spertino M, Gabbiadini R, Dal Buono A, Busacca A, et al · · 2024 · cited 4× · PMID 38673573 · DOI 10.3390/jcm13082300 -
Intriguing Role of the Mesentery in Ileocolic Crohn's Disease.
Turri G, Carvello M, Ben David N, Spinelli A. · · 2022 · cited 3× · PMID 35966976 · DOI 10.1055/s-0042-1743590 -
To cut or not to cut? Extended mesenteric excision during intestinal resection does not impact the postoperative recurrence nor the postoperative complications in Crohn's disease: a systematic review and meta-analysis.
Topala M, Martinekova P, Rancz A, Veres DS, et al · · 2025 · cited 2× · PMID 40057619 · DOI 10.1007/s10151-025-03110-w -
Effect of extensive mesenteric excision on primary ileocolic resection outcomes in Crohn's disease patients: a systematic review with meta-analysis.
Martínez-Pérez A, Schena CA, Pellino G, Martínez-López E, et al · · 2025 · PMID 41329358 · DOI 10.1007/s00384-025-05043-0
Verify or expand the search:
- PubMed search for NCT04578392
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04578392 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04578392.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing