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Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.

Study acronym: ROBOT-ECO-GYN
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 50 entriesv4
  2. Eligibility criteria expanded, about 82 words
    • Secondary endpoints: 46 to 50
    • Study sites revised (15)
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Apr 2024 to Sep 23, 2024
    • Primary and study completion dates: Oct 2027 to Mar 2028
    • Eligibility criteria shortened, about 42 words
    • Secondary endpoints: details revised at 2 of 46 entries
    • Site details revised at 15 of 15 sites
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study. Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy. Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient. The investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index.
Trial Details
NCT Number NCT06348719
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)		 Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
Enrollment 1,680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov