Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Trials. 2012 May 6;13:54. doi: 10.1186/1745-6215-13-54.
The use of lLaparoscopic liver resection in terms of time to functional recovery, length of hospital stay (LOS), long-term abdominal wall hernias, costs and quality of life (QOL) has never been studied in a randomised controlled trial. Therefore, this is the subject of the international multicentre randomised controlled ORANGE II trial.
Patients eligible for left lateral sectionectomy (LLS) of the liver will be recruited and randomised at the outpatient clinic. All randomised patients will undergo surgery in the setting of an ERAS programme. The experimental design produces two randomised arms (open and laparoscopic LLS) and a prospective registry. The prospective registry will be based on patients that cannot be randomised because of the explicit treatment preference of the patient or surgeon, or because of ineligibility (not meeting the in- and exclusion criteria) for randomisation in this trial. Therefore, all non-randomised patients undergoing LLS will be approached to participate in the prospective registry, thereby allowing acquisition of an uninterrupted prospective series of patients. The primary endpoint of the ORANGE II trial is time to functional recovery. Secondary endpoints are postoperative LOS, percentage readmission, (liver-specific) morbidity, QOL, body image and cosmetic result, hospital and societal costs over 1 year, and long-term incidence of incisional hernias. It will be assumed that in patients undergoing laparoscopic LLS, length of hospital stay can be reduced by two days. A sample size of 55 patients in each randomisation arm has been calculated to detect a 2-day reduction in LOS (90% power and α = 0.05 (two-tailed)).The ORANGE II trial is a multicenter randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing LLS within an enhanced recovery ERAS programme.
ClinicalTrials.gov NCT00874224.
腹腔镜肝切除术在功能恢复时间、住院时间（ LOS ）、长期腹壁疝、成本和生活质量（ QOL ）方面从未在随机对照试验中进行过研究。因此，这是国际多中心随机对照 ORANGE II 试验的主题。
将在门诊招募并随机选择符合左外侧肝段切除术（ LLS ）条件的患者。所有随机患者都将在 ERAS 计划的环境下进行手术。实验设计产生了两个随机组（开放和腹腔镜 LLS ）和一个前瞻性登记处。前瞻性登记处将基于不能随机分组的患者，原因是患者或外科医生明确的治疗偏好，或因不符合本试验的纳入和排除标准而不适合随机分组。因此，所有接受 LLS 的非随机患者都将被邀请参加前瞻性登记处，从而允许获得不间断的前瞻性患者系列。ORANGE II 试验的主要终点是功能恢复时间。次要终点是术后 LOS 、再入院率、（肝脏特异性）发病率、QOL 、身体形象和美容效果、1 年内的医院和社会成本以及长期切口疝发生率。假设接受腹腔镜 LLS 的患者，住院时间可以缩短两天。计算出每组 55 例随机分组的样本量，以检测 LOS 缩短 2 天（ 90%的功率和α=0.05 （双侧））。ORANGE II 试验是一项多中心随机对照试验，将为接受强化康复 ERAS 计划的 LLS 患者腹腔镜手术的优点提供证据。
ClinicalTrials.gov NCT00874224。
