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临床试验/NCT06750003
NCT06750003尚未招募不适用

4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison

Azienda Sanitaria-Universitaria Integrata di Udine0 个研究点目标入组 22 人开始时间: 2024年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
22
主要终点
operative time

研究概览

简要总结

Evaluate whether the 4K laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3D laparoscopy

详细描述

All patients diagnosed with suspected benign ovarian pathology based on preoperative examinations (pelvic Doppler ultrasound and/or magnetic resonance imaging and/or CT scan) and with indication for bilateral laparoscopic adnexectomy will be enrolled in the study. The primary objective of the study is to compare surgical times between the 3D and 4K vision systems in laparoscopic ovarian surgery, specifically in bilateral adnexectomy performed by trainee surgeons. Secondary objectives will include evaluating intra- and postoperative complications, length of hospital stay, and costs to the healthcare system

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with benign ovarian pathology requiring bilateral oophorectomy
  • ASA score <3
  • Patients who have signed the appropriate informed consent
  • Patients who are not pregnant or diagnosed with pelvic inflammatory disease
  • No history of prior major abdominal surgery

排除标准

  • Suspected neoplastic pathology
  • Patients not eligible for surgery

结局指标

主要结局

operative time

时间窗: from enrollment to the end of follow up at 12 months

To compare the operative time of bilateral oophorectomy performed using 3D laparoscopy versus 4K laparoscopy for benign indications, conducted by trainee surgeons.

次要结局

未报告次要终点

研究者

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

Stefano Restaino

Doctor

Azienda Sanitaria-Universitaria Integrata di Udine

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