Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases
研究概览
简要总结
This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.
详细描述
The study proposed comprises a prospective, single-center clinical trial (Catholic University of the Sacred Heart of Rome, A. Gemelli University Polyclinic).
One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.
Post-operative pain will be reported by the patients through a Visual Analog Scale (VAS). It will be assessed at 2, 4 and 12 and 24 hours after the procedure.
At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the standard laparoscopic approach to multiple access and/or to a laparotomic approach will be analyzed in order to arrive at the feasibility and efficacy of robotic assisted treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patient Inclusion Criteria:
- •Age ≥ 18 years old
- •Sign the informed consent form
- •A.S.A. Class < III or IV
- •Disease Inclusion Criteria:
- •Ovarian cyst (enucleation/oophorectomy)
- •Prophylactic bilateral oophorectomy
- •Ectopic pregnancy (salpingotomy/salpingectomy)
- •Tubal inflammatory disease (salpingotomy/salpingectomy)
- •Infertility and sterility (treatment of endometriosis, chromo-salpingography, etc.)
- •Benign uterine disease (Fibromatosis, Adenomyosis)
- •Endometrial hyperplasia
- •Stage Ia G1-2 Endometrial tumors
- •Precancerous lesions of the uterine cervix
- •Stage Ia uterine cervical tumors
- •Pelvic endometriosis
排除标准
- •Pregnancy
- •Liver disease
- •Coagulation disorders
- •Patient internal or anatomical criteria that preclude a laparoscopic approach
结局指标
主要结局
Feasibility and complications of robotic assisted surgery in the treatment of gynecological diseases
时间窗: Pre-operative to 30 days follow-up
The rate of complications and conversions to laparoscopic/laparotomic surgery will be collected and calculated. As this is a pilot study, no pre-determined success criteria has been set. The number of complications observed during robotic assisted surgery in the treatment of gynecological diseases will be registered.
次要结局
- Robotic assisted surgery learning curve assessed through the reduction of procedure times(Through study completion, on average 1 year)
- Post-operative pain(End of surgery to 24 hours post-op)
- Procedure times(Day of surgical intervention)
- Intra- and post-operative complications(Day of surgical intervention, 24h post-surgery and after 30-day follow-up)