Clinical Trial

Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy

Study acronym: COLERICA II
Not Yet Recruiting
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Summary
Background Acute cholecystitis (sudden gallbladder inflammation, usually due to gallstones) is a highly frequent surgical emergency. For patients with moderate disease (Grade II, according to the international Tokyo Guidelines 2018), current standards recommend performing keyhole surgery (early laparoscopic cholecystectomy) within 72 hours of admission or up to 10 days from symptom onset. While the surgical timing is well-defined, care management before, during, and after surgery varies greatly. Standardised care pathways called RICA (Rehabilitación Multimodal en Cirugía del Adulto), which align with global Enhanced Recovery After Surgery (ERAS) protocols, use evidence-based steps to protect body function, reduce pain without heavy opioid use, and help patients walk and eat sooner. Although highly successful in planned surgeries, there is very little specific data or standard pathways regarding the application of these recovery protocols in urgent, complex cases like Grade II acute cholecystitis. Purpose The main objective of this study is to evaluate the clinical efficiency and safety of implementing a standardized RICA perioperative care pathway in patients with Grade II acute cholecystitis undergoing early laparoscopic cholecystectomy, comparing them against a historical control group treated under conventional care. Description This single-centre, non-randomised interventional study uses a quasi-experimental, before-after design at the University Hospital of Igualada. The study will contrast two separate groups of adult patients aged between 18 and 85 years: * A historical control cohort (retrospective phase, 2023-2025) consisting of patients who received conventional, non-standardised care. * An intervention cohort (prospective phase, 2026-2029) consisting of patients treated strictly according to the new multidisciplinary RICA protocol. The study aims to demonstrate that standardising care reduces the total postoperative length of hospital stay (measured in hours) without increasing surgical complications or unplanned readmissions. All clinical variables, including patient risks, surgical difficulty scales, complications up to 90 days, and protocol compliance rates, will be securely managed using an institutional REDCap database.
Trial Details
NCT Number NCT07695922
Lead Sponsor Hospital d'Igualada
Collaborators: Consorci Sanitari de l'Anoia
Conditions Cholecystitis, Acute, Cholecystectomy, Laparoscopic, Enhanced Recovery After Surgery
Enrollment 146 participants
Start Date 2026-07-10
Primary Completion 2029-02-28 (estimated)
Study Completion 2029-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-10