Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 564
- 试验地点
- 3
- 主要终点
- Rate of satisfactory completion of staging surgery according to the criteria of national and international guidelines for the treatment of endometrial carcinoma.
研究概览
简要总结
Prospective Multicenter Observational Study The study involves the consecutive inclusion of every patient with endometrial cancer undergoing staging surgical treatment using a robotic approach with the da Vinci SP platform.
详细描述
The standard treatment for early-stage endometrial cancer is surgical staging, which includes total hysterectomy with bilateral salpingo-oophorectomy and surgical lymph node assessment.
The well-known advancements in minimally invasive surgery (MIS) have enabled laparoscopic and robotic surgical staging in gynecologic oncology. In the case of endometrial cancer, MIS is indeed the preferred surgical approach. Following the approval of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) for gynecological procedures by the United States Food and Drug Administration in 2005, the use of robotic surgery for endometrial cancer has significantly increased, with favorable outcomes even compared to conventional laparoscopy.
The growing need for increasingly less invasive surgical options has led to the development of the possibility to perform endometrial cancer surgical staging through a single abdominal incision. Despite several attempts to apply single-incision techniques to laparoscopy in the context of endometrial cancer, the standard minimally invasive approach for hysterectomy remains the four-trocar laparoscopic technique. One of the main reasons is that introducing both the endoscope and instruments through a single incision creates internal and external conflicts between instruments and the surgeon's hands. The parallel placement of surgical instruments leads to clashes and restricts the range of motion.
To overcome these limitations, robotic technology may be applied to the single-incision technique. The recent introduction of single-port robotic surgery with the fourth-generation da Vinci® SP Surgical System represents a technological advancement. In fact, the system's flexible articulation of instruments allows for more effective manipulation while reducing instrument collisions. Moreover, the flexible camera provides a new operational angle in all directions.
The new da Vinci SP Surgical System (SP) received regulatory approval for use in gynecologic surgery in Italy in 2024. However, to date, studies in the literature on the use of the da Vinci SP robot in patients with endometrial cancer are limited due to the relatively small number of patients, single-center settings, and the retrospective nature of most studies.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically confirmed endometrial carcinoma (including uterine carcinosarcoma)
- •Performance status (ECOG) 0 - 1
- •Patients undergoing staging surgery for endometrial cancer, including but not limited to robotic hysterectomy with bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) and possible sentinel lymph node biopsy/pelvic ± para-aortic lymphadenectomy
- •Signed informed consent to participate in the study
排除标准
- •Patients scheduled for an additional extra-genital surgical procedure during the staging surgery for endometrial carcinoma
- •Patients with anesthesiological contraindications to a minimally invasive approach
- •Synchronous tumor
- •Recurrence of endometrial carcinoma
- •Dementia or significantly altered mental status that may impair understanding and the ability to provide informed consent
- •Any reason that may interfere with regular follow-up, even if limited to the first 30 days post-surgery
结局指标
主要结局
Rate of satisfactory completion of staging surgery according to the criteria of national and international guidelines for the treatment of endometrial carcinoma.
时间窗: 12 months
Rate of intraoperative complications, after categorization based on the type of complication and the timing of its occurrence.
时间窗: 12 months
Rate of postoperative complications, after categorization based on the type of complication (within 30 days after surgery, after 30 days post-surgery) and according to the Clavien-Dindo classification.
时间窗: 48 months
次要结局
- Disease-Free Survival (DFS) calculated from the date of randomization to the date of death from any cause or censored at the date of the last follow-up, after categorization based on molecular class and tumor prognostic factors.(up to 48 months (4 years))
- Overall Survival (OS) calculated from the date of randomization to the date of death from any cause or censored at the date of the last follow-up, after categorization based on molecular class and tumor prognostic factors.(up to 48 months (4 years))
- Quality of Life (QoL) assessed using the questionnaires from the EORTC QLQ-C30 (Version 3).(From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months)
- Quality of Life (QoL) assessed using the questionnaires from EORTC QLQ-OV28.(From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months)
- Quality of Life (QoL) assessed using the questionnaires from the EQ-5D-3L.(From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months)