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NOT YET RECRUITING
NCT07695922
NA

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

Sponsor: Hospital d'Igualada

View on ClinicalTrials.gov

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.

Official title: A Single-Centre, Non-Randomised Interventional Study for the Implementation of the Enhanced Recovery After Surgery (RICA) Guidelines in Patients With Tokyo Guidelines 2018 Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2026-07-10

Completion Date

2029-04-01

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

OTHER

RICA Perioperative Care Pathway

A standardized, multidisciplinary, evidence-based clinical pathway designed to optimize perioperative recovery for patients undergoing emergency laparoscopic cholecystectomy for Grade II acute cholecystitis. The intervention replaces conventional practitioner-dependent care with a highly structured time-matrix protocol including: preoperative point-of-care ultrasound (POCUS), frailty screening, restricted fasting windows, strict glycaemic control (\<180 mg/dL), and antimicrobial stewardship; intraoperative goal-directed fluid therapy, mandatory core normothermia maintenance, restricted use of routine abdominal drains/catheters, and opioid-sparing multimodal analgesia (abdominal wall blocks); and postoperative early mobilization (within 8 hours), early oral intake (within 6 to 8 hours), and standardized multi-professional discharge criteria checking.

Locations (1)

Hospital Universitari d'Igualada

Igualada, Barcelona, Spain