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临床试验/NCT05974995
NCT05974995招募中不适用

Robotic-assisted Versus Conventional Laparoscopic Surgery in the Management of Obese Patients With Early Endometrial Cancer in the Sentinel Lymph Node Era: a Randomized Controlled Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 566 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
566
试验地点
2
主要终点
Conversion rate

研究概览

简要总结

Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations.

This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI >= 30) patients with endometrial carcinoma.

详细描述

Background:

Endometrial cancer is the fourth cancer in women, the most common gynecologic cancer in high-income countries and the second most common gynecologic cancer worldwide.

The high incidence of endometrial cancer is associated with several risk factors, but the growing prevalence of obesity has been identified as one of the majors. Many patients with endometrial cancer are obese and have clinically relevant coexisting conditions that negatively affects anesthesiological parameters and surgical performance when patients undergo surgery, thus potentially increasing the risk of peri-operative complications.

For patients presenting at early-stage disease the standard procedure is total hysterectomy with bilateral salpingo-oophorectomy and lymph nodal staging. Prospective and retrospective studies demonstrate that compared to systemic lymphadenectomy, sentinel lymph node mapping have high accuracy in detecting nodal metastases, and together with ultrastaging may increase the detection of lymph node metastasis with low false-negative rates in patients with apparent uterine-confined disease. Also, recent evidence proved sentinel lymph node biopsy to be a feasible and safe alternative to lymphadenectomy in high-risk endometrial cancer.

Many randomized prospective studies proved laparoscopic surgical staging to be feasible in terms of short-term outcomes, equivalent in disease-free survival and no different in overall survival, thus the current surgical approach is minimally invasive. Also, innovative surgical approaches such as robotic surgery have been exploited showing equivalent oncologic outcomes when compared to traditional laparoscopic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI >=30
  • Age > 18
  • Histologically confirmed endometrioid endometrial cancer
  • Clinical early stage (stage I)
  • No contraindication for minimally invasive surgery
  • Written informed consent.

排除标准

  • High probability of laparotomy related to uterine volume (US estimated weight >250 g)
  • Concomitant pelvic disease, or anatomical characteristics of the patient
  • (Use of uterine manipulator)
  • Age >75 years

结局指标

主要结局

Conversion rate

时间窗: At the end of the enrollment phase

Number of procedures converted to laparotomy from MIS

次要结局

  • Difference in overall duration of surgery(At the end of the enrollment phase)
  • Adherence to sentinel lymph node MSKCC algorithm(At the end of the enrollment phase)
  • Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery(1 and 4 weeks (early), and 3 and 6 months (late) after surgery)
  • Ergonomics of the two different surgical approach(At the end of the enrollment phase)
  • Difference in perioperative complications(36 and 72 months)
  • Adherence to ESGO surgical Quality Index(36 and 72 months)
  • Difference in overall survival and disease-free survival(36 and 72 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fanfani Francesco

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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