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

NCT07695922 | Not Yet Recruiting

• 1 other identifier: CSA-4-2026-AC
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute cholecystitis; Laparoscopic cholecystectomy; Enhanced recovery after surgery; Clinical pathways; Perioperative care; Emergency surgery; Tokyo Guidelines; Length of hospital stay; Quasi-experimental study

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Postoperative Morbidity Rate

  Up to 90 days postoperatively.

• Unplanned Hospital Readmission Rate

  Up to 90 days post-discharge.

• RICA Protocol Adherence Index

  From hospital admission up to formal hospital discharge (estimated up to 7 days).

Study Arms (2)

RICA Pathway

EXPERIMENTAL

Prospective cohort of patients diagnosed with Tokyo Guidelines 2018 (TG18) Grade II acute cholecystitis managed prospectively between March 2026 and February 2029. Participants in this arm undergo early laparoscopic cholecystectomy within 72 hours of admission and are treated strictly according to the institutional multidisciplinary RICA (Rehabilitación Multimodal en Cirugía del Adulto) pathway. This evidence-based care bundle integrates pre-emptive frailty screening, restricted fasting windows, targeted point-of-care ultrasound (POCUS), strict perioperative glycaemic control (\< 180 mg/dL), intraoperative goal-directed fluid therapy, mandatory maintenance of core normothermia, systematic avoidance of routine abdominal drains, and opioid-sparing multimodal analgesia (including abdominal wall blocks). Postoperative care dictates early mobilisation within 8 hours and early oral intake within 6 to 8 hours of surgery.

Other: RICA Perioperative Care Pathway

Conventional Care

NO INTERVENTION

Retrospective historical control cohort comprising patients diagnosed with Tokyo Guidelines 2018 (TG18) Grade II acute cholecystitis who underwent early laparoscopic cholecystectomy at the same institution between January 2023 and December 2025. Participants in this arm were managed under conventional, non-standardised perioperative care practices prior to the formal clinical implementation of the RICA pathway. Clinical decisions regarding preoperative fasting duration, intraoperative fluid management, routine placement of abdominal drains, nasogastric tubes, or urinary catheters, types of intraoperative analgesia (including reliance on systemic opioids), and milestones for postoperative mobilization and oral intake progression were dependent on individual practitioner preference and standard ward routines.

Interventions

RICA Perioperative Care Pathway OTHER

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.

RICA Pathway

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Anoia: collaborator
• Hospital d'Igualada: lead

Study Sites (1)

Hospital Universitari d'Igualada

Igualada, Barcelona, 08700, Spain

Location

Related Publications (31)

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Related Links

• Acalovschi M. The Growing Global Burden of Gallstone Disease. World Gastroenterology Organisation, 2012. Review article on the global epidemiology of gallstone disease.
• Grupo Español de Rehabilitación Multimodal (GERM). Protocolos Zaragoza: Colecistitis Aguda Complicada (K81). Working group protocol, updated October 2022.
• Working Group. Vía Clínica de Recuperación Intensificada en Cirugía del Adulto (RICA). Spanish Ministry of Health, 2021. National enhanced recovery clinical pathway.
• Dindo D. The Clavien-Dindo Classification of Surgical Complications. In: Treatment of Postoperative Complications After Digestive Surgery. Springer, London, 2014.
• ERAS Society. ERAS Guidelines. Official website of the ERAS Society listing enhanced recovery clinical guidelines by surgical specialty.

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Cesar Alejandro Anaya Romo, MD

  Consorci Sanitari de l'Anoia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Alejandro Anaya Romo, MD

CONTACT

+34680523403; aanaya@csa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: While the clinical study is fundamentally open-label due to the practical nature of implementing a care pathway intervention (preventing the blinding of participants, care providers, and operating surgeons), an independent blinding protocol has been established for data analysis. The data analyst is a professional biostatistician from the institution's research department who has no involvement in the clinical management of the patients, patient recruitment, or database management. To ensure robust outcome assessment, a strict split-functional data segregation model is applied. All clinical variables recorded in the institutional REDCap database are fully pseudo-anonymised by the Principal Investigator before the analytical phase. The biostatistician will conduct the multivariable regression analyses and propensity score matching working exclusively with this de-identified data matrix.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employs a quasi-experimental, sequential before-after design, structured clinically as a non-randomised parallel cohort model. Due to the nature of implementing an institutional care pathway, allocation is non-randomised and chronologically driven. Participants are assigned to one of two distinct parallel groups based on their date of admission: a retrospective historical control group (January 2023 to December 2025) managed under conventional surgical care, or a prospective intervention group (March 2026 to February 2029) managed strictly under the multi-professional RICA pathway. To control for the inherent lack of randomisation and mitigate potential period-related confounding factors between both cohorts, a rigorous Propensity Score Matching (PSM) sensitivity analysis (1:1 ratio) will be executed to balance baseline demographics and surgical risk profiles.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)