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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Postoperative Length of Hospital Stay
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Postoperative Length of Hospital Stay
时间窗: From the time of surgery completion up to formal hospital discharge (estimated up to 90 days postoperatively).
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.
次要结局
- 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).)