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三维与二维高清腹腔镜经腹腹膜前腹股沟疝修补术的前瞻性随机对照研究。

Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.

机构信息

Department of Abdominal Surgery, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.

Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

出版信息

Surg Endosc. 2020 Nov;34(11):4857-4865. doi: 10.1007/s00464-019-07266-z. Epub 2019 Nov 21.

Abstract

BACKGROUND

Three-dimensional (3D) laparoscopy improves technical efficacy in laboratory environment, but evidence for clinical benefit is lacking. The aim of this study was to determine whether the 3D laparoscopy is beneficial in transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP).

METHOD

In this prospective, single-blinded, single-center, superior randomized trial, patients scheduled for TAPP were randomly allocated to either 3D or two-dimensional (2D) TAPP laparoscopic approaches. Patients were excluded if secondary operation was planned, the risk of conversion was high, or the surgeon had less than five previous 3D laparoscopic procedures. Patients were operated on by 13 residents and 3 attendings. The primary endpoint was operation time. The study was registered in ClinicalTrials.gov (NCT02367573).

RESULTS

Total 278 patients were randomized between 5th February 2015 and 23rd October 2017. Median operation time was shorter in the 3D group (56.0 min vs. 68.0 min, p < 0.001). 10 (8%) patients in 3D group and 6 (5%) patients in 2D group had clinically significant complications (Clavien-Dindo 2 or higher) (p = 0.440). Rate of hernia recurrence was similar between groups at 1-year follow-up. In the subgroup analyses, operation time was shorter in 3D laparoscopy among attendings, residents, female surgeons, surgeons with perfect stereovision, surgeons with > 50 3D laparoscopic procedures, surgeons with any experience in TAPP, patients with body mass indices < 30, and bilateral inguinal hernia repairs.

CONCLUSION

3D laparoscopy is beneficial and shortens operation time but does not affect safety or long-term outcomes of TAPP.

摘要

背景

三维(3D)腹腔镜技术在实验室环境中提高了技术效果,但缺乏临床获益的证据。本研究旨在确定 3D 腹腔镜在经腹腹膜前腹腔镜腹股沟疝修补术(TAPP)中的应用是否有益。

方法

这是一项前瞻性、单盲、单中心、优效随机临床试验,计划接受 TAPP 的患者被随机分配至 3D 或二维(2D)TAPP 腹腔镜手术组。如果计划进行二次手术、中转开腹风险高或术者 3D 腹腔镜手术经验少于 5 例,则排除患者。由 13 名住院医师和 3 名主治医生进行手术。主要结局指标为手术时间。本研究在 ClinicalTrials.gov 注册(NCT02367573)。

结果

2015 年 2 月 5 日至 2017 年 10 月 23 日期间,共 278 例患者随机分组。3D 组的中位手术时间更短(56.0 分钟 vs. 68.0 分钟,p<0.001)。3D 组 10 例(8%)患者和 2D 组 6 例(5%)患者出现临床显著并发症(Clavien-Dindo 2 级或更高)(p=0.440)。两组在 1 年随访时的疝复发率相似。亚组分析显示,在主治医生、住院医师、女性术者、立体视觉良好术者、3D 腹腔镜手术经验>50 例、TAPP 手术经验、BMI<30、双侧腹股沟疝修补术的患者中,3D 腹腔镜手术时间更短。

结论

3D 腹腔镜技术有益且可缩短手术时间,但不影响 TAPP 的安全性和长期结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce5b/7572346/706d7d19e4af/464_2019_7266_Fig1_HTML.jpg

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