评估 ArtiSential 在各种肾脏手术中的适用性：IDEAL 阶段 1 研究。

Evaluation of the suitability of using ArtiSential in various renal surgery: IDEAL stage 1 study.

机构信息

Department of Urology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.

Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

出版信息

BMC Urol. 2024 Aug 1;24(1):164. doi: 10.1186/s12894-024-01539-z.

DOI:10.1186/s12894-024-01539-z

PMID:39090576

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11293067/

Abstract

BACKGROUND

ArtiSential, a new articulating laparoscopic instruments, addresses the limited movement associated with conventional laparoscopic instruments. This study was conducted to assess the clinical effectiveness of ArtiSential in detailed steps of various renal surgery.

METHODS

This study was approved by the Institutional Review Board of our institution and registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency. Participants meeting all inclusion and exclusion criteria were included in the clinical trial and underwent renal surgery. The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters across 9 detailed steps.

RESULTS

Of the 15 potential candidates enrolled from October 2021 to November 2021, 1 patient dropped out due to anaphylaxis from an anesthetic agent, and 14 patients underwent laparoscopic surgery using ArtiSential. Of the 14 patients, 2 patients were converted to laparoscopic surgery using straight-shaped instruments due to the ischemia time exceeding 30 min, and 1 patient due to excessive bleeding. The feasibility for most steps was more than 90%, except the renorrhaphy step. The median total operation time and ischemia time were 161 and 23 min, respectively. The median estimated blood loss was 58.5 mL. Two cases of venous injury occurred during renal pedicle dissection step. The accuracy of the procedure judged by reviewers and usability judged by the operator were acceptable in all steps. The surgeon's quantitatively measured stress score was the highest during renorrhaphy step.

CONCLUSIONS

Laparoscopic surgery using ArtiSential is feasible for most steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, which could be addressed by overcoming the learning curve.

TRIAL REGISTRATION

Clinical Research Information Service site of the Korea Disease Control and Prevention Agency, KCT0006532. Registered 03/09/2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24071 .

摘要

背景

ArtiSential 是一种新型的铰接式腹腔镜器械，解决了传统腹腔镜器械运动受限的问题。本研究旨在评估 ArtiSential 在各种肾脏手术的详细步骤中的临床效果。

方法

本研究经机构审查委员会批准，并在韩国疾病控制与预防机构的临床研究信息服务网站上注册。符合所有纳入和排除标准的参与者被纳入临床试验，并接受了肾脏手术。通过 9 个详细步骤评估 ArtiSential 的临床效果，包括可行性以及客观和主观参数。

结果

2021 年 10 月至 11 月期间，从 15 名潜在候选人中纳入了 14 名患者，其中 1 名患者因麻醉剂过敏而退出，1 名患者因缺血时间超过 30 分钟而转为使用直形器械进行腹腔镜手术，1 名患者因过度出血而转为使用直形器械进行腹腔镜手术。除了肾脏缝合步骤外，大多数步骤的可行性都超过 90%。中位总手术时间和缺血时间分别为 161 分钟和 23 分钟。中位估计出血量为 58.5 毫升。在肾脏蒂解剖步骤中有 2 例静脉损伤。审查员判断的程序准确性和操作员判断的可用性在所有步骤中均可以接受。在肾脏缝合步骤中，外科医生的定量测量应激评分最高。