跳至主要内容
临床试验/NCT06050161
NCT06050161尚未招募不适用

Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

Kern Medical Center0 个研究点目标入组 50 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Vaginal cuff suturing time

研究概览

简要总结

This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.

详细描述

The Artisential laparoscopic instrument is a novel device that allows multi-directional articulation during laparoscopic surgery. There are currently no studies evaluating the efficacy or safety of this device in minimally invasive gynecologic surgery. The investigators aim to compare the efficacy and safety of the Artisential instrument with conventional laparoscopic or robotic instruments.

Patients who are scheduled for a laparoscopic or robotic hysterectomy and/or laparoscopic or robotic sacrocolpopexy will be invited to participate in this study. During the suturing portion of the surgery (either vaginal cuff closure during a hysterectomy, or mesh attachment during a sacrocolpopexy), operating times and safety outcomes will be measured. The approach for vaginal cuff closure will be randomly selected. The approach for mesh attachment suturing will be based on the primary surgical approach (conventional laparoscopy or robotic) and compared to suturing with the Artisential and an internally controlled environment. Therefore, half of the knots placed during a case will be with the Artisential laparoscopic device, and the other half will be placed either with robotic instruments or conventional laparoscopic instruments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The patient will not be told which surgical approaches were used during surgery

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patient scheduled for robotic or laparoscopic total hysterectomy
  • •Patient scheduled for robotic or laparoscopic sacrocolpopexy

排除标准

  • •Not a candidate for the above surgical procedures

研究组 & 干预措施

Artisential laparoscopic instrument

Experimental

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Articulating laparoscopic instrument (Device)

Artisential laparoscopic instrument

Experimental

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Conventional laparoscopic instrument (Device)

Artisential laparoscopic instrument

Experimental

Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Robotic surgical instrument (Device)

Conventional laparoscopic instrument

Active Comparator

Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Articulating laparoscopic instrument (Device)

Conventional laparoscopic instrument

Active Comparator

Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Conventional laparoscopic instrument (Device)

Conventional laparoscopic instrument

Active Comparator

Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Robotic surgical instrument (Device)

Robotic instrument

Active Comparator

Robotic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Articulating laparoscopic instrument (Device)

Robotic instrument

Active Comparator

Robotic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Conventional laparoscopic instrument (Device)

Robotic instrument

Active Comparator

Robotic instrument use for suturing during minimally invasive gynecologic surgery

干预措施: Robotic surgical instrument (Device)

结局指标

主要结局

Vaginal cuff suturing time

时间窗: Intraoperative

Time to complete closure of the vaginal cuff

Mesh suturing time

时间窗: Intraoperative

Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.

次要结局

  • Surgical complications(Intraoperative)
  • Knot tying times(Intraoperative)
  • Knot location(Intraoperative)
  • Needling times(Intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yufan Chen

Chief, Division of Urogynecology, Department of Obstetrics and Gynecology

Kern Medical Center

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