Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- The robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis
研究概览
简要总结
The aim is to clarify whether both surgical approaches represent, equivalently, a good treatment for the management of patients with deep endometriosis who are candidates for surgery, or whether there are any differences between the two methods, and, if so, how they differ
详细描述
Numerous studies have shown how surgical excision of deep endometriosis nodules improves pain and quality of life. Robotic-assisted laparoscopic surgery has been employed for the treatment of deep endometriosis. While the Da Vinci System is widely used for the surgical treatment of endometriosis, with good results, the available data regarding the benefits of the HUGO RAS System, however, are limited, given the recent introduction of this method in gynecology, and particularly in the treatment of endometriosis. The aim of the study is to investigate whether the robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 55 years;
- •Pelvic ultrasound and/or radiologic (MRI/CT scan with rectal insufflation) diagnosis of endometriosis
- •Indication for surgery (symptomatic despite or refractory to medical therapy, and/or with critical bowel stenosis or urinary stenosis, and/or infertile awaiting medically assisted procreation (PMA) treatment or with previous failed assisted fertilization attempts);
- •ASA (American Society of Anesthesiologists physical status classification) class between 1 and 3;
- •Acquisition of consent to undergo surgical treatment;
- •Acquisition of consent for study participation and data processing
排除标准
- •Past or current diagnosis of gynecologic oncologic pathology.
结局指标
主要结局
The robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis
时间窗: During surgery
Compare the two surgical techniques by evaluating the operative time (expressed in minutes), which includes docking and surgical time. Docking is defined as the time required to move the robotic arms into the operative field, place them in their respective port sites, and insert the robotic instruments into the abdomen. Surgical time is from the end of docking to suturing the laparoscopic/laparotomy breaches.
次要结局
- Conversion rate to laparoscopy or laparotomy(During surgery)
- Intra-operative and post-operative complication rates; need for complication treatment(Perioperative and at 3 months)
- Ergonomics for the surgeon(During surgery)
- Entity of postoperative pain(Perioperative and at 3 and 12 months)
- Hospitalization time(From the day of admission to the day of discharge, an average of 1 year)
- Assessment of pain and quality of life(At 3 and 12 months after surgery)
- Symptomatological and/or anatomical recurrence(At 12 months after surgery)