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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis, Acute; Cholecystectomy, Laparoscopic; Enhanced Recovery After Surgery
• Intervention / Treatment: Other: RICA Perioperative Care Pathway

Detailed Description

Introduction and Clinical Framework

Acute cholecystitis constitutes one of the most prevalent acute surgical conditions managed within emergency departments across Europe. Epidemiological indicators highlight a rising incidence, particularly within the population over 65 years of age. While cholelithiasis affects approximately 10% to 15% of the general adult population, up to 40% of these individuals experience stone-related complications, with acute cholecystitis serving as the primary clinical manifestation in a substantial proportion of symptomatic cases.

The Tokyo Guidelines 2018 (TG18) represent the international gold standard for the diagnosis and severity stratification of this condition. Grade II (moderate) acute cholecystitis is characterised by marked local inflammation that complicates direct surgical management. Diagnostic features for Grade II include a marked leukocytosis (white blood cell count greater than 18,000/mm³), a tender palpable mass in the right upper abdominal quadrant, or a duration of clinical symptoms exceeding 72 hours. It also encompasses advanced local inflammatory findings confirmed via diagnostic imaging, such as gangrenous, emphysematous, or pericolecystic abscess formations, hepatic abscesses, or biliary peritonitis.

The seminal multi-centre randomised controlled trial (ACDC study) established the clinical superiority of early laparoscopic cholecystectomy over conservative management followed by delayed elective surgery, showing significant reductions in patient morbidity, hospital stay, and resource utilization. Current consensus guidelines from the World Society of Emergency Surgery (WSES) define early cholecystectomy as an intervention performed within 7 days of hospital admission or up to 10 days from the onset of clinical symptoms. While the technical advantages of early surgery in Grade II cases are recognised-offering a viable laparoscopic window before tissue fibrosis sets in-there is a critical lack of standardized perioperative management frameworks tailored specifically for this urgent, moderately severe cohort, as most general Enhanced Recovery After Surgery (ERAS) data originates from elective colorectal or mild (Grade I) cholecystitis pathways.

Study Objectives and Hypotheses

The primary objective of this study is to evaluate the clinical efficiency and recovery optimization of an institutional RICA protocol implementation for TG18 Grade II acute cholecystitis managed via early laparoscopic cholecystectomy. The core hypothesis is that the systematic and multi-professional standardisation of care will significantly reduce the postoperative length of hospital stay (measured precisely in hours) without increasing overall 90-day postoperative morbidity or unplanned hospital readmissions.

The secondary objectives are:

1. To compare baseline characteristics and clinical outcomes between the intervention group and historical controls to assess protocol impact.
2. To monitor perioperative morbidity by tracking the incidence and severity of surgical complications using the Clavien-Dindo classification up to 90 days postoperatively.
3. To determine the rate and underlying causes of unplanned hospital readmissions within a 90-day postoperative window.

Methodology and Work Plan

This investigation employs a quasi-experimental, single-centre, before-after cohort design conducted at the University Hospital of Igualada (Catalonia, Spain). The study architecture is divided into two sequential chronological periods:

• The Retrospective Phase (Historical Control Group, January 2023 - December 2025): Medical records of consecutive patients matching the inclusion criteria who underwent conventional surgical and perioperative care will be reviewed to establish a robust baseline.
• The Prospective Phase (Intervention Group, March 2026 - February 2029): Consecutive patients will be prospectively enrolled, providing written informed consent, and managed strictly in accordance with the multidisciplinary RICA care matrix.

The project timeline dictates a one-week formal introduction to brief and align the departments of General Surgery, Anaesthesiology, and Emergency and Wards Nursing, alongside the deployment of the REDCap data infrastructure. The inclusion and data capture phase spans 36 months, followed by a 6-month data cleaning, 90-day follow-up completion, and final statistical analysis phase. The final 6 months are dedicated to scientific manuscript preparation following the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) statement guidelines.

The RICA Perioperative Care Matrix

The active intervention evaluated in this study replaces conventional practitioner-dependent management with a highly structured, time-sequenced multimodal care pathway involving surgeons, anaesthetists, and specialised nursing staff. The protocol is structured as follows:

1. Preoperative Stage: Includes point-of-care ultrasound (POCUS) clinical assessment; systematic evaluation of surgical risk and patient frailty using validated clinical frailty scores; strict glycaemic control aiming to maintain blood glucose below 180 mg/dL; targeted antimicrobial prophylaxis governed by hospital antibiotic stewardship guidelines (PROA); active thermal management using forced-air warming blankets for vulnerable or frail individuals; and targeted patient education detailing early recovery objectives.
2. Intraoperative Stage: Use of the surgical safety checklist; routine advanced monitoring; execution of standard or subtotal laparoscopic cholecystectomy (documenting fenestrated or reconstituted approaches, or conversion to open surgery); rapid sequence anaesthetic induction; controlled hyperoxia ($FiO_2$ 0.6 to 0.8); goal-directed fluid therapy (utilising non-invasive advanced haemodynamic monitoring systems like Clearsight) or weight-adjusted restrictive fluid administration (3-5 mL/kg/h); mandatory core normothermia maintenance; strict restriction of routine nasogastric tubes, urinary catheters, or abdominal drainage placement; and the mandatory application of opioid-sparing multimodal analgesia via local wound infiltration or Transversus Abdominis Plane (TAP) blocks.
3. Immediate Postoperative Stage (Day 0): Continued active warming; oxygen therapy adjusted to blood oxygen saturation; multimodal non-opioid analgesia restricting morphic rescue doses; restrictive fluid maintenance; early mobilization protocol requiring sitting within 2 hours and active ambulation within 8 hours post-surgery; and early oral intake initiation (clear fluids) within 6 to 8 hours of the procedure.
4. Postoperative Day 1: Progression to a liquid diet; active ambulation and targeted respiratory physiotherapy; transition to oral analgesia; discontinuation of intravenous fluid lines upon adequate oral tolerance; and initial evaluation for the removal of any intraoperatively placed drains or catheters.
5. Postoperative Day 2 & Extended Stay: Advancement to a progressive low-fat biliary diet; full independent ambulation; continued oral analgesia and PROA-aligned antibiotic therapy; and daily formal assessment against discharge criteria.
6. Discharge and Follow-up Criteria: Discharge is authorized only when the patient meets all standard criteria: absence of fever, adequate pain control via oral analgesia, complete independent ambulation, active patient acceptance, and a pre-discharge objective laboratory check measuring C-Reactive Protein (CRP) and liver function enzymes. Post-discharge care includes an institutional 24-hour telephone follow-up call, coordinated continuity with primary care medical teams, and a formal clinical follow-up assessment at 3 to 4 weeks.

Advanced Statistical Analysis Strategy

All data management will be executed utilizing the REDCap platform. Statistical computing will be performed using R software (version 4.3 or higher), with a fixed significance threshold of $p < 0.05$. Continuous variables will be evaluated for normality via the Shapiro-Wilk test and expressed as mean and standard deviation (SD) or median and interquartile range (IQR). Categorical variables will be analysed using Chi-squared or Fisher's exact tests.

To evaluate the primary outcome (postoperative length of stay in hours), a multivariable linear regression model will be constructed. The dependent variable will be the log-transformed length of stay to account for non-normal distributions, with group allocation (RICA pathway vs. conventional care) serving as the main independent predictor. The model will be adjusted for key baseline covariates exhibiting unbalance, alongside established clinical confounders including age, ASA physical status, clinical frailty score, comorbidities, and initial biochemical severity indicators.

To account for the inherent selection bias of a non-randomised before-after design and mitigate period-related confounding, an advanced sensitivity analysis using Propensity Score Matching (PSM) will be implemented. Propensity scores will be calculated for each patient via a logistic regression model incorporating baseline demographics and clinical risks. Patients from the historical and prospective cohorts will be matched using a 1:1 nearest-neighbour algorithm, creating a balanced sub-cohort to isolate the true therapeutic effect of the RICA intervention.

Furthermore, a Cox proportional hazards regression model will be deployed to evaluate the time-to-discharge rate, treating the hospital discharge as the event of interest, complemented by Kaplan-Meier survival curves. To prove causal association, an institutional compliance index (0% to 100%) will be calculated for each intervention patient based on the percentage of RICA items fulfilled; a linear regression will test the direct correlation between high protocol adherence and reduced hospital stay. For the safety endpoint (Clavien-Dindo complications $\ge$ II), a formal non-inferiority analysis will be performed, applying a pre-specified safety margin of 5% to confirm that the RICA pathway does not compromise patient safety. Missing data patterns will be checked; if random and under 5%, complete-case analysis will be used, otherwise multiple imputation techniques will be applied.

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesar Alejandro Anaya Romo, MD; Phone Number: +34680523403; Email: aanaya@csa.cat

Study Locations

• Spain
  • Barcelona
    • Igualada, Barcelona, Spain, 08700
      • Hospital Universitari d'Igualada
      • Contact: Cristina Pozo Salgado, MSc; Phone Number: +34666441852; Email: cpozo@csa.cat
      • Contact: Marta Banque Navarro, PhD; Phone Number: +34938075585; Email: mbanque@csa.cat
      • Sub-Investigator: Xavier Viñas Trullen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RICA Pathway; 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; 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.
No Intervention: Conventional Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 90 days postoperatively.
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.	Up to 90 days post-discharge.
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%).	From hospital admission up to formal hospital discharge (estimated up to 7 days).

Collaborators and Investigators

• Sponsor: Hospital d'Igualada
• Collaborators: Consorci Sanitari de l'Anoia
• Investigators: Principal Investigator: Cesar Alejandro Anaya Romo, MD, Consorci Sanitari de l'Anoia

Publications and helpful links

General Publications

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
• Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
• Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.
• Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
• Paton F, Chambers D, Wilson P, Eastwood A, Craig D, Fox D, Jayne D, McGinnes E. Effectiveness and implementation of enhanced recovery after surgery programmes: a rapid evidence synthesis. BMJ Open. 2014 Jul 22;4(7):e005015. doi: 10.1136/bmjopen-2014-005015.
• Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
• Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
• Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
• Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
• Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.
• Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
• Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.
• Ljungqvist O, Nygren J, Thorell A. Modulation of post-operative insulin resistance by pre-operative carbohydrate loading. Proc Nutr Soc. 2002 Aug;61(3):329-36. doi: 10.1079/PNS2002168.
• Demouron M, Selvy M, Dembinski J, Mauvais F, Cheynel N, Slim K, Sabbagh C, Regimbeau JM. Feasibility and Effectiveness of an Enhanced Recovery Program after Early Cholecystectomy for Acute Calculous Cholecystitis: A 2-Step Study. J Am Coll Surg. 2022 May 1;234(5):840-848. doi: 10.1097/XCS.0000000000000123.
• Griffiths EA, Hodson J, Vohra RS, Marriott P; CholeS Study Group; Katbeh T, Zino S, Nassar AHM; West Midlands Research Collaborative. Utilisation of an operative difficulty grading scale for laparoscopic cholecystectomy. Surg Endosc. 2019 Jan;33(1):110-121. doi: 10.1007/s00464-018-6281-2. Epub 2018 Jun 28.
• Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016.
• Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995.
• Wakabayashi G, Iwashita Y, Hibi T, Takada T, Strasberg SM, Asbun HJ, Endo I, Umezawa A, Asai K, Suzuki K, Mori Y, Okamoto K, Pitt HA, Han HS, Hwang TL, Yoon YS, Yoon DS, Choi IS, Huang WS, Gimenez ME, Garden OJ, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Liu KH, Su CH, Misawa T, Nakamura M, Horiguchi A, Tagaya N, Fujioka S, Higuchi R, Shikata S, Noguchi Y, Ukai T, Yokoe M, Cherqui D, Honda G, Sugioka A, de Santibanes E, Supe AN, Tokumura H, Kimura T, Yoshida M, Mayumi T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: surgical management of acute cholecystitis: safe steps in laparoscopic cholecystectomy for acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):73-86. doi: 10.1002/jhbp.517. Epub 2018 Jan 10.
• Loozen CS, van Ramshorst B, van Santvoort HC, Boerma D. Early Cholecystectomy for Acute Cholecystitis in the Elderly Population: A Systematic Review and Meta-Analysis. Dig Surg. 2017;34(5):371-379. doi: 10.1159/000455241. Epub 2017 Jan 18.
• Ugarte-Sierra B, Landaluce-Olavarria A, Cabrera-Serna I, Vinas-Trullen X, Brugiotti C, Ramirez-Rodriguez JM, Arroyo A. Enhanced Recovery After Emergency Surgery: Utopia or Reality? Cir Esp (Engl Ed). 2021 Apr;99(4):258-266. doi: 10.1016/j.ciresp.2020.04.017. Epub 2020 Jun 10. English, Spanish.
• Qin J, Gou LY, Zhang W, Pu X, Zhang P. Enhanced Recovery After Surgery versus Conventional Care in Cholecystectomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2024 Aug;34(8):710-720. doi: 10.1089/lap.2024.0119. Epub 2024 Jul 8.
• Nassar A, Elshahat I, Forsyth K, Shaikh S, Ghazanfar M. Outcome of early cholecystectomy compared to percutaneous drainage of gallbladder and delayed cholecystectomy for patients with acute cholecystitis: systematic review and meta-analysis. HPB (Oxford). 2022 Oct;24(10):1622-1633. doi: 10.1016/j.hpb.2022.04.010. Epub 2022 May 6.
• Meyer AE, Pfeiffer CA, Brooks KE, Spate LD, Benne JA, Cecil R, Samuel MS, Murphy CN, Behura S, McLean MK, Ciernia LA, Smith MF, Whitworth KM, Wells KD, Spencer TE, Prather RS, Geisert RD. New perspective on conceptus estrogens in maternal recognition and pregnancy establishment in the pigdagger. Biol Reprod. 2019 Jul 1;101(1):148-161. doi: 10.1093/biolre/ioz058.
• Nguyen KT, Marsh JW, Tsung A, Steel JJ, Gamblin TC, Geller DA. Comparative benefits of laparoscopic vs open hepatic resection: a critical appraisal. Arch Surg. 2011 Mar;146(3):348-56. doi: 10.1001/archsurg.2010.248. Epub 2010 Nov 15.
• Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
• Arenas DL, Viduani A, Bassols AMS, Hauck S. Work From Home or Bring Home the Work? Burnout and Procrastination in Brazilian Workers During the COVID-19 Pandemic. J Occup Environ Med. 2022 May 1;64(5):e333-e339. doi: 10.1097/JOM.0000000000002526. Epub 2022 Feb 24.
• Roulin D, Donadini A, Gander S, Griesser AC, Blanc C, Hubner M, Schafer M, Demartines N. Cost-effectiveness of the implementation of an enhanced recovery protocol for colorectal surgery. Br J Surg. 2013 Jul;100(8):1108-14. doi: 10.1002/bjs.9184.
• Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9.
• Gomes CA, Junior CS, Di Saverio S, Sartelli M, Kelly MD, Gomes CC, Gomes FC, Correa LD, Alves CB, Guimaraes SF. Acute calculous cholecystitis: Review of current best practices. World J Gastrointest Surg. 2017 May 27;9(5):118-126. doi: 10.4240/wjgs.v9.i5.118.
• Tsuyumu M, Tsurumoto T, Iimura J, Nakajima T, Kojima H. Response to a letter to the editor titled, "Weight loss in patients with obstructive sleep apnea: an interventional procedure". Sleep Breath. 2021 Jun;25(2):1165-1166. doi: 10.1007/s11325-020-02154-6. Epub 2020 Oct 28. No abstract available.
• Li N, Yang F, Zhao Z, Jiang J, Lei Y. Efficacy and safety of Naoxintong capsule for acute ischemic stroke: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Aug 27;100(34):e27120. doi: 10.1097/MD.0000000000027120.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative care; Laparoscopic cholecystectomy; Emergency surgery; Length of hospital stay; Acute cholecystitis; Enhanced recovery after surgery; Clinical pathways; Quasi-experimental study; Tokyo Guidelines
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: CSA-4-2026-AC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared due to explicit legal restrictions stipulated in the patient informed consent form approved by the institutional ethics committee. The approved protocol restricts data access strictly to the primary research team and its authorized internal collaborators to ensure compliance with the General Data Protection Regulation (GDPR) and national data protection laws. However, aggregate data and specific methodological details will be fully available in the final publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No