[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646178":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":60,"collaborators":62,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":96,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Hospital d'Igualada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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 (\\\u003C 180 mg\u002FdL), 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.",[13],"Other: RICA Perioperative Care Pathway",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"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 (\\\u003C180 mg\u002FdL), and antimicrobial stewardship; intraoperative goal-directed fluid therapy, mandatory core normothermia maintenance, restricted use of routine abdominal drains\u002Fcatheters, 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.",[9],[25],{"name":26,"affiliation":27,"role":28},"Cesar Alejandro Anaya Romo, MD","Consorci Sanitari de l'Anoia","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+34680523403","aanaya@csa.cat",[35],{"facility":36,"status":18,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital Universitari d'Igualada","Igualada","Barcelona","08700","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],1.6172,41.58098,{"lat":46,"lon":45},[49,53,57],{"name":50,"role":31,"phone":51,"phoneExt":18,"email":52},"Cristina Pozo Salgado, MSc","+34666441852","cpozo@csa.cat",{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Marta Banque Navarro, PhD","+34938075585","mbanque@csa.cat",{"name":58,"role":59,"phone":18,"phoneExt":18,"email":18},"Xavier Viñas Trullen, MD","SUB_INVESTIGATOR",{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[63],{"name":27,"class":6},"100646178","implementation-of-rica-eras-guidelines-in-grade-ii-acute-cholecystitis-undergoing-early-laparoscopic-cholecystectomy-100646178",false,"NCT07695922","Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy","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","COLERICA II","Inclusion Criteria:\n\n* Patients aged 18 to 85 years, inclusive.\n* Confirmed diagnosis of Grade II (moderate) acute cholecystitis based on the Tokyo Guidelines 2018 (TG18) criteria.\n* Patients scheduled for laparoscopic cholecystectomy within 72 hours of hospital admission and up to 10 days from symptom onset.\n* American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.\n\nExclusion Criteria:\n\n* Ongoing therapeutic anticoagulation or dual antiplatelet therapy that cannot be safely suspended or modified for surgery.\n* Concurrent advanced chronic liver disease (Child-Pugh class B or C), severe acute biliary pancreatitis, or associated complex biliary tract pathology.\n* Active SARS-CoV-2 (COVID-19) infection confirmed by polymerase chain reaction (PCR).\n* Refusal or inability to provide written informed consent for the prospective phase of the study.","ALL","18 Years","85 Years",{"count":76,"type":77},146,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nPurpose 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.\n\nDescription\n\nThis 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:\n\n* A historical control cohort (retrospective phase, 2023-2025) consisting of patients who received conventional, non-standardised care.\n* An intervention cohort (prospective phase, 2026-2029) consisting of patients treated strictly according to the new multidisciplinary RICA protocol.\n\nThe 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.",[83,84,85],"Cholecystitis, Acute","Cholecystectomy, Laparoscopic","Enhanced Recovery After Surgery",[87,88,89,90,91,92,93,94,95],"Acute cholecystitis","Laparoscopic cholecystectomy","Enhanced recovery after surgery","Clinical pathways","Perioperative care","Emergency surgery","Tokyo Guidelines","Length of hospital stay","Quasi-experimental study","NOT_YET_RECRUITING","2026-07-06",{"date":99,"type":100},"2026-07-10","ACTUAL",{"date":99,"type":77},{"date":103,"type":77},"2029-04-01",{"name":5,"class":6},1]