Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Nutrim School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.
Br J Surg. 2017 Apr;104(5):525-535. doi: 10.1002/bjs.10438. Epub 2017 Jan 31.
Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided.
In this multicentre double-blind RCT, patients (aged 18-80 years with a BMI of 18-35 kg/m and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery.
Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3-5) days for OLLS versus 3 (3-3) days for LLLS; and 3 (3-3) days for ONR versus 3 (3-4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates.
This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 ( https://www.clinicaltrials.gov).
与开放左外侧肝段切除术（OLLS）相比，腹腔镜左外侧肝段切除术（LLLS）与较短的住院时间和降低的整体发病率相关。然而，并没有提供强有力的证据。
在这项多中心双盲 RCT 中，需要左外侧肝段切除术（LLS）的患者（年龄在 18-80 岁之间，BMI 为 18-35kg/m，ASA 身体状况为 III 级或以下）在术后强化康复（ERAS）方案内随机分配接受 OLLS 或 LLLS。所有随机患者、病房医生和护士对手术过程均不知情。一个平行的前瞻性登记处（开放非随机（ONR）与腹腔镜非随机（LNR））用于监测由于医生或患者偏好而未被随机分配的患者。主要终点是功能恢复的时间。次要终点是住院时间（LOS）、再入院率、整体发病率、肝外科特定发病率的复合终点、死亡率以及功能恢复后出院延迟的原因。
2010 年 1 月至 2014 年 7 月，在十个中心招募了患者。其中，有 24 名患者在 8 个中心随机分组，有 67 名患者在 8 个中心纳入前瞻性登记处。由于入组缓慢，在荷兰一个独立的数据和安全监测委员会的建议下，该试验被停止。在随机或非随机组中，腹腔镜和开放手术在功能恢复的中位（IQR）时间上没有显著差异：OLLS 为 3（3-5）天，LLLS 为 3（3-3）天；ONR 为 3（3-3）天，LNR 为 3（3-4）天。在 LOS、发病率、再次手术、再入院和死亡率方面没有显著差异。
在 ERAS 环境中比较开放和腹腔镜 LLS 的这项 RCT 由于入组缓慢而提前停止，无法得出关于功能恢复时间的结论。注册号：NCT00874224（https://www.clinicaltrials.gov）。
