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.
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.
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.
Parallel
RICA Perioperative Care Pathway
Other interventionA 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.
Postoperative Length of Hospital Stay
The total duration of hospitalisation calculated in hours, measured from the exact time of the completion of the laparoscopic cholecystectomy (skin closure) until the exact time of formal hospital discharge.
Postoperative Morbidity Rate
Incidence and severity of complications occurring after surgery, graded according to the international Clavien-Dindo classification. The primary safety focus will be on significant complications classified as Grade II or higher (Clavien-Dindo $\\ge$ II), which include infections requiring specific antimicrobial therapies, leaks, or collections requiring intervention.
Unplanned Hospital Readmission Rate
The percentage of patients requiring any unplanned or emergency hospital readmission related to the primary surgical condition, surgical site complications (such as intra-abdominal collections, surgical site infections, or biliary leaks), or systemic medical complications secondary to the intervention.
RICA Protocol Adherence Index
An institutional compliance score calculated as the percentage of implemented RICA protocol care items successfully fulfilled for each patient out of the total applicable items across the preoperative, intraoperative, and postoperative care matrix (expressed as a continuous scale from 0% to 100%).
Click on the lead sponsor to view all of their trials.
Hospital d'Igualada
Lead sponsor
Consorci Sanitari de l'Anoia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
