Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease: A Randomized Controlled, Open, Parallel, Non-inferiority, Single-center Trial (STaRLING Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Incidence (%) of postoperative complications within 30 days after surgery
研究概览
简要总结
This is a single-center, randomized controlled, parallel, non-inferiority trial. All adult patients with benign gallbladder disease with an indication for cholecystectomy will be assessed for eligibility and included after obtaining informed consent. A total of 276 patients will be randomized to undergo either robotic cholecystectomy (RC) or laparoscopic cholecystectomy (LC). The primary endpoint will be the incidence and severity of postoperative complications within 30 days after surgery. Secondary endpoints include perioperative outcomes, total health care utilization, health-related quality of life (HR-QoL) as assessed by patient-reported outcome measures, and cost-effectiveness. Follow-up assessments will be conducted at 7 and 30 days postoperatively.
This is the first randomized controlled trial designed to compare RC with LC in the treatment of benign gallbladder disease. The trial aims to evaluate the safety and non-inferiority of RC relative to LC, providing important evidence to guide the progress and adoption of robotic surgery in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal or above 18 years;
- •Benign gallbladder disease: diagnosis of gallbladder polyps or symptomatic gallstones proven on imaging (ultrasound, computed tomography (CT) scan or magnetic resonance cholangiopancreatography (MRCP));
- •Capacity to give informed consent.
排除标准
- •Minimally invasive procedure is not deemed possible by the operating surgeon;
- •Evidence of acute cholecystitis;
- •Known stones in the common bile duct (CBD);
- •Suspicion of possible malignancy;
- •Pregnancy;
- •Diagnosis of liver cirrhosis (stage III or IV);
- •Insufficient language skills to be able to perform the quality-of-life questionnaires.
研究组 & 干预措施
Laparoscopic cholecystectomy
Conventional multiport laparoscopic cholecystectomy
干预措施: Laparoscopic cholecystectomy (Procedure)
Robotic cholecystectomy
Robotic multiport cholecystectomy
干预措施: Robotic cholecystectomy (Procedure)
结局指标
主要结局
Incidence (%) of postoperative complications within 30 days after surgery
时间窗: From day of surgery up to 30 days postoperatively
The incidence (%) of postoperative complications occurring within 30 days after surgery in patients with benign gallbladder disease. The outcome compares the total number of complications between patients treated with robotic cholecystectomy (RC) and those treated with laparoscopic cholecystectomy (LC).
Severity of postoperative complications within 30 days after surgery
时间窗: From day of surgery up to 30 days postoperatively
Complication severity will be graded using the Clavien-Dindo classification: 1. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. 2. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. 3. Requiring surgical, endoscopic or radiological intervention i. intervention not under general anaesthesia ii. intervention under general anaesthesia 4. Life-threatening complication (including central nervous system complications), requiring management in an Intensive Care Unit (ICU). 5. Death of a patient
Frequency (%) of postoperative complications within 30 days postoperatively
时间窗: From day of surgery up to 30 days postoperatively
The frequency (%) of individual postoperative complications occurring within 30 days following surgery in patients undergoing cholecystectomy.
Comprehensive Complication Index (CCI) score within 30 days after surgery
时间窗: From day of surgery up to 30 days postoperatively
The Comprehensive Complication Index (CCI) is a validated score based on the Clavien-Dindo classification system that quantifies all postoperative complications occurring within 30 days after surgery. The score ranges from 0 (no complications) to 100 (death), reflecting the cumulative burden of morbidity per patient.
次要结局
- Duration of the procedure (minutes)(Intraoperatively)
- Peri-operative blood loss (millilitres)(Intraoperatively)
- Intra-abdominal pressure (mmHg) during surgery(Intraoperatively)
- Incidence (%) of gallbladder perforation during surgery(Intraoperatively)
- Incidence (%) of intraoperative complications(Intraoperatively)
- Technical difficulty of the procedure graded according to Nassar classification(Intraoperatively)
- Assessment of liver parenchyma during surgery(Intraoperatively)
- Proportion of procedures in which common bile duct (CBD) assessment was performed(Intraoperatively)
- Proportion (%) of patients who underwent common bile duct (CBD) exploration(Intraoperatively)
- Use of peri-operative antibiotics(Intraoperatively)
- Incidence (%) and number of drains placed during surgery(Intraoperatively)
- Surgical perceived effort measured by Surgical Task Load Index (SURG TLX)(Intraoperatively)
- Analgesia required in the recovery period(From arrival in recovery room until discharge from recovery)
- Opioids prescribed upon discharge(At hospital discharge (day of discharge))
- Frequency (%) of same-day discharge(From surgery until discharge on the same day)
- Time from theatre departure to stage 3 recovery (minutes)(From theatre departure until arrival in stage 3 recovery)
- Readmission rate (%) within 30 days after surgery(From day of surgery to 30 days postoperatively)
- Incidence (%) of interventions needed within 30 days after cholecystectomy(From day of surgery to 30 days postoperatively)
- Health-related quality of life measured by EuroQol 5D-5L (EQ-5D-5L)(At baseline (preoperative), on the day of hospital discharge, at 7 days postoperatively, and at 30 days postoperatively)
- Gallstone-specific quality of life measured by Otago Condition-Specific Questionnaire (O-CSQ)(At baseline (preoperative) and at 30 days postoperatively)
- Quality of recovery measured by Quality of Recovery 15 (QoR-15) questionnaire(At hospital discharge, 7 days postoperatively, and 30 days postoperatively)
- Cost-effectiveness based on hospital costs within 30 days after surgery(From day of surgery up to 30 days postoperatively)