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Abstract：
BACKGROUND: The advantages of laparoscopic left-sided hepatectomy (LLH) for treating hepatolithiasis in terms of the time to postoperative length of hospital stay (LOS), morbidity, long-term abdominal wall hernias, hospital costs, residual stone rate, and recurrence of calculus have not been confirmed by a randomized controlled trial. The aim of this trial is to compare the safety and effectiveness of LLH with open left-sided hepatectomy (OLH) for the treatment of hepatolithiasis.
METHODS: Patients with hepatolithiasis eligible for left-sided hepatectomy will be recruited. The experimental design will produce two randomized arms (laparoscopic and open hepatectomy) at a 1:1 ratio and a prospective registry. All patients will undergo surgery in the setting of an enhanced recovery after surgery (ERAS) programme. The prospective registry will be based on patients who cannot be randomized because of the explicit treatment preference of the patient or surgeon or because of ineligibility (not meeting the inclusion and exclusion criteria) for randomization in this trial. The primary outcome is the LOS. The secondary outcomes are percentage readmission, morbidity, mortality, hospital costs, long-term incidence of incisional hernias, residual stone rate, and recurrence of calculus. It will be assumed that, in patients undergoing LLH, the length of hospital stay will be reduced by 1 day. A sample size of 86 patients in each randomization arm has been calculated as sufficient to detect a 1-day reduction in LOS [90% power and α = 0.05 (two-tailed)]. The trial is a randomized controlled trial that will provide evidence for the merits of laparoscopic surgery in patients undergoing liver resection within an ERAS programme.
CONCLUSIONS: Although the outcomes of LLH have been proven to be comparable to those of OLH in retrospective studies, the use of LLH remains restricted, partly due to the lack of short- and long-term informative RCTs pertaining to patients with hepatolithiasis in ERAS programmes. To evaluate the surgical and long-term outcomes of LLH, we will perform a prospective RCT to compare LLH with OLH for hepatolithiasis within an ERAS programme.
BACKGROUND: ClinicalTrials.gov NCT03958825. Registered on 21 May 2019.
METHODS: Patients with hepatolithiasis eligible for left-sided hepatectomy will be recruited. The experimental design will produce two randomized arms (laparoscopic and open hepatectomy) at a 1:1 ratio and a prospective registry. All patients will undergo surgery in the setting of an enhanced recovery after surgery (ERAS) programme. The prospective registry will be based on patients who cannot be randomized because of the explicit treatment preference of the patient or surgeon or because of ineligibility (not meeting the inclusion and exclusion criteria) for randomization in this trial. The primary outcome is the LOS. The secondary outcomes are percentage readmission, morbidity, mortality, hospital costs, long-term incidence of incisional hernias, residual stone rate, and recurrence of calculus. It will be assumed that, in patients undergoing LLH, the length of hospital stay will be reduced by 1 day. A sample size of 86 patients in each randomization arm has been calculated as sufficient to detect a 1-day reduction in LOS [90% power and α = 0.05 (two-tailed)]. The trial is a randomized controlled trial that will provide evidence for the merits of laparoscopic surgery in patients undergoing liver resection within an ERAS programme.
CONCLUSIONS: Although the outcomes of LLH have been proven to be comparable to those of OLH in retrospective studies, the use of LLH remains restricted, partly due to the lack of short- and long-term informative RCTs pertaining to patients with hepatolithiasis in ERAS programmes. To evaluate the surgical and long-term outcomes of LLH, we will perform a prospective RCT to compare LLH with OLH for hepatolithiasis within an ERAS programme.
BACKGROUND: ClinicalTrials.gov NCT03958825. Registered on 21 May 2019.
摘要：
背景：就术后住院时间（LOS）而言，腹腔镜左肝切除术（LLH）治疗肝胆管结石的优势，发病率，长期腹壁疝,医院费用,残石率，并且结石复发尚未得到随机对照试验的证实。该试验的目的是比较LLH与开放式左侧肝切除术（OLH）治疗肝胆管结石的安全性和有效性。
方法：将招募符合左侧肝切除术条件的肝胆管结石患者。实验设计将以1：1的比例和前瞻性注册表产生两个随机臂（腹腔镜和开腹肝切除术）。所有患者都将在手术后恢复（ERAS）计划的背景下接受手术。前瞻性注册将基于由于患者或外科医生的明确治疗偏好或由于不适合（不符合纳入和排除标准）而无法随机化的患者。主要结果是LOS。次要结果是再入院百分比，发病率，死亡率,医院费用,切口疝的长期发病率，残石率，和结石复发。人们会假设,在接受LLH的患者中，住院时间将减少1天。已计算出每个随机化组中86名患者的样本量足以检测到LOS降低1天[90％功率和α=0.05（双尾）]。该试验是一项随机对照试验，将为在ERAS计划中接受肝切除术的患者进行腹腔镜手术的优点提供证据。
结论：尽管在回顾性研究中已证明LLH的结果与OLH的结果相当，LLH的使用仍然受到限制，部分原因是ERAS项目中缺乏与肝胆管结石患者相关的短期和长期信息RCT。为了评估LLH的手术和长期结果，我们将在ERAS计划中进行前瞻性RCT，以比较LLH与OLH的肝胆管结石。
背景：ClinicalTrials.govNCT03958825。2019年5月21日注册。
方法：将招募符合左侧肝切除术条件的肝胆管结石患者。实验设计将以1：1的比例和前瞻性注册表产生两个随机臂（腹腔镜和开腹肝切除术）。所有患者都将在手术后恢复（ERAS）计划的背景下接受手术。前瞻性注册将基于由于患者或外科医生的明确治疗偏好或由于不适合（不符合纳入和排除标准）而无法随机化的患者。主要结果是LOS。次要结果是再入院百分比，发病率，死亡率,医院费用,切口疝的长期发病率，残石率，和结石复发。人们会假设,在接受LLH的患者中，住院时间将减少1天。已计算出每个随机化组中86名患者的样本量足以检测到LOS降低1天[90％功率和α=0.05（双尾）]。该试验是一项随机对照试验，将为在ERAS计划中接受肝切除术的患者进行腹腔镜手术的优点提供证据。
结论：尽管在回顾性研究中已证明LLH的结果与OLH的结果相当，LLH的使用仍然受到限制，部分原因是ERAS项目中缺乏与肝胆管结石患者相关的短期和长期信息RCT。为了评估LLH的手术和长期结果，我们将在ERAS计划中进行前瞻性RCT，以比较LLH与OLH的肝胆管结石。
背景：ClinicalTrials.govNCT03958825。2019年5月21日注册。
