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

NCT07695922 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Cholecystitis, Acute
  • Cholecystectomy, Laparoscopic
  • Enhanced Recovery After Surgery

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.

Sponsors & Collaborators

  • Consorci Sanitari de l'Anoia

    collaborator OTHER
  • Hospital d'Igualada

    lead OTHER

Principal Investigators

  • Cesar Alejandro Anaya Romo, MD · Consorci Sanitari de l'Anoia

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2029-02-28
Completion
2029-04-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695922 on ClinicalTrials.gov