跳至主要内容
临床试验/CTRI/2023/11/060042
CTRI/2023/11/060042已完成不适用

A Retrospective Multicenter Real-World Evidence Study of Open, Laparoscopic and Robotic-assisted Staging Surgery for Endometrial Cancer

Intuitive Surgical Pvt. Ltd. India15 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2023年11月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8,000
试验地点
15
主要终点
The primary outcome of this study is to retrospectively assess the perioperative outcomes through discharge and the short-term clinical outcomes from discharge to 90 days after open, laparoscopic, or robotic-assisted staging surgery for endometrial cancer

研究概览

简要总结

From a treatment standpoint, multidisciplinary, multimodality treatment is indicated for the management of endometrial cancer. For Endometrial cancer cases suitable for surgery (irrespective of stage), Total hysterectomy with Bilateral salpingo-oophorectomy (TH/BSO) with surgical staging is offered. Adjuvant radiation (brachytherapy/EBRT) with/without systemic therapy is offered, depending on patients and disease factors. In patients not suitable for surgery, radiation and/or systemic therapy are offered. Patients are then re-evaluated for surgical resection. While offering surgical treatment to patients with Stages I, II, and III endometrial cancer, the selection of technique (open, laparoscopic, or robotic-assisted) is an important discussion point amongst the surgical team as well as with the patient. Leading guidelines advocate TH/BSO and lymph node assessment may be performed by any surgical route (eg, laparoscopic, robotic, vaginal, abdominal. Although these guidelines recommend a minimally invasive approach as the standard in uterine-confined disease due to a lower rate of surgical site infection, transfusion, venous thromboembolism, decreased hospital stay, and lower cost of care, without compromise in oncologic outcomes. There is a large body of global published literature with respect to the techniques of surgery for endometrial cancer. However, the majority of evidence emanates from the Western world, and there is a paucity of evidence in Indian settings. We could not find any multi-centric study from India for any of these techniques (single arm or multiple cohorts). To fill this gap, there is a need for a multi-centric real-world evidence study from India that can serve as a local benchmark for perioperative, oncological, and functional outcomes for staging surgery for endometrial cancer.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • Subject who was 18 years of age or older at the time of surgery
  • Subject who has undergone any of open, laparoscopic and robotic-assisted staging surgery [total hysterectomy with or without any of the following: (a) bilateral salpingo-oophorectomy, (b) peritoneal cytology/lavage, (c) lymph node dissection, (d) adhesiolysis, (e) sentinel lymph node mapping, (f) omentectomy] for Stages I-III endometrial cancer (Stage I-III, as per 8th Edn, 2017 AJCC TNM and FIGO Surgical Staging Systems for Endometrial Cancer).

排除标准

  • Subject who has undergone any of open, laparoscopic and robotic-assisted endometrial resection for Stage IV endometrial cancer (as per 8th Edn, 2017 AJCC TNM and FIGO Surgical Staging Systems for Endometrial Cancer).

结局指标

主要结局

The primary outcome of this study is to retrospectively assess the perioperative outcomes through discharge and the short-term clinical outcomes from discharge to 90 days after open, laparoscopic, or robotic-assisted staging surgery for endometrial cancer

时间窗: Till discharge, and from discharge to 90 days after surgery

次要结局

  • The secondary outcome of this study is to retrospectively assess the oncological outcomes, disease-free survival, and overall survival from postoperative day 91 and beyond up to 5 years after open, laparoscopic, or(robotic-assisted staging surgery for endometrial cancer)

研究者

发起方
Intuitive Surgical Pvt. Ltd. India
申办方类型
Other [Medical Device Company]
责任方
Principal Investigator
主要研究者

Dr Jaydip Bhaumik

Tata Medical Center

研究点 (15)

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