NCT06067971已完成不适用
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.
University Hospital, Clermont-Ferrand5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- The feasibility of augmented reality will be measure using the SURG-TLX scale
研究概览
简要总结
Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 (included) and 84 (included),
- •Patient with intrauterine myoma, with indication for surgical management by laparoscopic myomectomy, or uterine pathology with indication for surgical management by laparoscopic hysterectomy,
- •Patient affiliated or beneficiary of a health insurance scheme,
- •Patient agreeing to participate in the study after having received the written information document and signed the consent form.
排除标准
- •Patients under 18 or over 84 years of age,
- •Patients with contraindications to MRI (pacemaker, ocular metal splinters, etc.),
- •Impossibility of planned surgery,
- •Patient with endometrial cancer contraindicating laparoscopic surgery,
- •Known pregnant or breast-feeding patient,
- •Patient of legal age, under guardianship or curatorship,
- •Patients whose regular follow-up is impossible for geographical, psychological, family or social reasons (these reasons will be collected).
结局指标
主要结局
The feasibility of augmented reality will be measure using the SURG-TLX scale
时间窗: In the intra-operative phase of the study
The feasibility of the technique will be considered satisfactory if the SURG-TLX score given by the surgeon at the end of the procedure is less than or equal to 33.7 (threshold defined by experts).
次要结局
- Number of intraoperative and postoperative complications(From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery)
- Number of device failures during surgery(In the intra-operative phase of the study)
- Number of laparoscopic/laparotomy conversions(In the intra-operative phase of the study)
- Score of the surgeon's performance in using the augmented reality device(In the intra-operative phase of the study)
- Number of failures to start up the software(In the intra-operative phase of the study)
- Quantification of bleeding(In the intra-operative phase of the study)
- Collection of operative time(In the intra-operative phase of the study)
- Collection of the real direct medical costs of the procedure from an institutional point of view.(From the date of the surgery to the date of the first post-operative visit, usually 1 month after the surgery)
研究者
研究点 (5)
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