Department of Surgery, Cantonal Hospital of Winterthur, Brauerstrasse 15, 8401, Winterthur, Switzerland.
Surg Endosc. 2019 May;33(5):1482-1490. doi: 10.1007/s00464-018-6430-7. Epub 2018 Sep 14.
Although single-port laparoscopic cholecystectomy (SILC) is safe and effective, inherent surgeons' discomfort has prevented a large-scale adaptation of this technique. Recent advances in robotic technology suggest that da Vinci Single-Site™ cholecystectomy (dVSSC) may overcome this issue by reducing the stress load of the surgeon compared to SILC. However, evidence to objectively assess differences between the two approaches is lacking.
60 patients [36 women, 24 men (mean age 52 years)] with benign gallbladder disease were randomly assigned to dVSSC (n = 30) or SILC (n = 30) in this single-centre, single-blinded controlled trial. The primary endpoint was surgeon's stress load. Secondary endpoints included operating time, conversion rates, additional trocar placement, blood loss, length of hospital stay, procedure costs, health-related quality of life, cosmesis and complications. Data were collected preoperatively, during the hospital stay, and at 1 and 12 months' follow-up.
The dVSSC group showed a significant reduction of mental stress load of the surgeon compared to SILC [Subjective Mental Effort Questionnaire (SMEQ) score: median 25.0 (range 8-89) vs. 42.5 (range 13-110) points; p = 0.002] and a trend towards reduced physical stress load [Local Experienced Discomfort (LED) score: median 8 (range 2-27) vs. 12 (range 0-64) points; p = 0.088]. The length of hospital stay was longer in the SILC group [mean 3.06 (median 2; range 1-26) vs. 1.9 (median 2; range 1-4) days, p = 0.034] but overall hospital costs were higher for dVSSC [median 9734 (range 5775-16729) vs. 6900 (range 4156-99977) CHF; p = 0.001]. There were no differences in the rate of postoperative complications that required re-intervention (Dindo-Clavien grade ≥ IIIa; SILC n = 2 vs. dVSSC n = 0, p = 0.492) or other secondary endpoints.
Da Vinci Single-Site™ cholecystectomy provides significant benefits over Single-Port Laparoscopic Cholecystectomy in terms of surgeon's stress load, matches the standards of the laparoscopic single-incision approach with regard to patients' outcomes but increases expenses. Clinicaltrials.gov registration-No.: NCT02485392.
虽然单孔腹腔镜胆囊切除术（SILC）是安全有效的，但由于外科医生的固有不适感，该技术尚未得到广泛应用。机器人技术的最新进展表明，与 SILC 相比，达芬奇单部位™胆囊切除术（dVSSC）可能通过降低外科医生的应激负荷来克服这一问题。然而，缺乏客观评估两种方法之间差异的证据。
60 例[36 例女性，24 例男性（平均年龄 52 岁）]良性胆囊疾病患者在本中心单盲对照试验中随机分配至 dVSSC（n=30）或 SILC（n=30）组。主要终点是外科医生的应激负荷。次要终点包括手术时间、中转率、额外套管针放置、出血量、住院时间、手术费用、健康相关生活质量、美容效果和并发症。数据在术前、住院期间和 1 个月及 12 个月随访时收集。
dVSSC 组外科医生的精神应激负荷明显低于 SILC 组[主观精神努力问卷（SMEQ）评分：中位数 25.0（范围 8-89） vs. 42.5（范围 13-110）分；p=0.002]，且躯体应激负荷有降低趋势[局部体验不适（LED）评分：中位数 8（范围 2-27） vs. 12（范围 0-64）分；p=0.088]。SILC 组的住院时间较长[平均 3.06（中位数 2；范围 1-26） vs. 1.9（中位数 2；范围 1-4）天，p=0.034]，但 dVSSC 组的整体住院费用较高[中位数 9734（范围 5775-16729） vs. 6900（范围 4156-99977）瑞士法郎；p=0.001]。需要再次干预的术后并发症发生率（Dindo-Clavien 分级≥IIIa；SILC n=2 与 dVSSC n=0，p=0.492）或其他次要终点均无差异。
达芬奇单部位™胆囊切除术在外科医生的应激负荷方面优于单孔腹腔镜胆囊切除术，在患者结局方面与腹腔镜单切口方法标准相当，但增加了费用。Clinicaltrials.gov 注册号：NCT02485392。
