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临床试验/NCT01247779
NCT01247779已完成不适用

Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy

Centre Oscar Lambret17 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2010年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
386
试验地点
17
主要终点
Perioperative morbidity at six months

研究概览

简要总结

The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

详细描述

Laparoscopic surgery, also called minimally invasive surgery (MIS), is a surgical method less invasive than classical laparoscopic open procedure. Particularly, MIS is used for resection of some gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. Several studies demonstrated that MIS induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure.

However, MIS is the selected method in only 9 to 25 % of gynecologic cancer surgery in France. This is likely due to the longer learning curve of MIS compared to laparoscopic open procedure.

In 2001 the FDA allowed the use of robot assisted laparoscopic surgery (RALS). This technique adds some advantage to laparoscopic surgery. Indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-D image of the surgical field. Moreover learning curve of RALS is shorter than MIS. Comparative studies between RALS and MIS demonstrate an equivalence of these techniques for operation length and bleeding. However for surgery linked complications and time for recovery of activity, RALS had better results than MIS.

Despite its expensive cost, RALS is now commonly used in North America (90% of prostatectomy and 40% of cancer linked hysterectomy). However RALS need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in France.

Thus, the purpose of the ROBOGYN clinical trial is to compare clinical benefit of RALS and MIS in a randomized study for patients with cancer of cervix, uterus or ovary.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patient with uterus cancer depending on hysterectomy ± pelvic lymphadenectomy or a restadification
  • patient with cervical cancer depending on enlarged colpo-hysterectomy ± pelvic lymphadenectomy or a surgery after concomitant radiochemotherapy, or lombo aortic lymphadenectomy for a locally advanced cancer, or a restadification
  • patient with cervical cancer depending on a restadification
  • patient aged over 18 years
  • previous antitumor treatment allowed but necessarily disrupted 20 days before inclusion
  • WHO score equal or inferior to 3
  • cirrhosis-related Child-Pugh score under or equal to A7 are allowed
  • life expectancy equal or superior to 12 weeks
  • patient affiliated to health insurance
  • dated and signed informed consent

排除标准

  • metastatic disease
  • pregnant or breastfeeding woman
  • patient unable to proceed follow-up visit, because of geographic, social or mental reasons

研究组 & 干预措施

Standard Coelioscopy

Active Comparator

gynecologic surgery - standard coelioscopy

干预措施: gynecologic surgery - standard coelioscopy (Procedure)

Robot-assisted coelioscopy

Experimental

gynecologic surgery - robot assisted coelioscopy

干预措施: gynecologic surgery - robot assisted coelioscopy (Procedure)

结局指标

主要结局

Perioperative morbidity at six months

时间窗: six months after surgery

To estimate the rate of complications within the first six months after surgery, according to the Clavien-Dindo and NCI CTCAE-v4.0 grading scales

次要结局

  • Anatomopathology(during surgery)
  • Patient-reported survey of patient health(until 2 years after surgery)
  • Anesthesic and ventilator parameters(every 30 min during the surgery)
  • Post-operative analgesia(at 24h, 48h after sugery and until discharge)
  • Surgeon's ergonomy(every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale))
  • Description of surgical procedures(during surgery)
  • Progression-free survival(until 2 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

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