Not Yet RecruitingNot Applicable

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

Spain146 participantsStarted 2026-07-10

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 to 85 years, inclusive. * Confirmed diagnosis of Grade II (moderate) acute cholecystitis based on the Tokyo Guidelines 2018 (TG18) criteria. * Patients scheduled for laparoscopic cholecystectomy within 72 hours of hospital admission and up to 10 days from symptom onset. * American Society of Anesthesiologists (ASA) physical status classification of I, II, or III. Exclusion Criteria: * Ongoing therapeutic anticoagulation or dual antiplatelet therapy that cannot be safely suspended or modified for surgery. * Concurrent advanced chronic liver disease (Child-Pugh class B or C), severe acute biliary pancreatitis, or associated complex biliary tract pathology. * Active SARS-CoV-2 (COVID-19) infection confirmed by polymerase chain reaction (PCR). * Refusal or inability to provide written informed consent for the prospective phase of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Length of Hospital Stay

Timeframe: From the time of surgery completion up to formal hospital discharge (estimated up to 90 days postoperatively).

Trial details

NCT IDNCT07695922

SponsorHospital d'Igualada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-28

Contact for this trial

Cesar Alejandro Anaya Romo, MD

+34680523403 aanaya@csa.cat

View on ClinicalTrials.gov More Cholecystitis, Acute trials