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Studies

Interventional Recruiting

NCT06348719 on ClinicalTrials.gov

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

Official title: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer: Multicentre Randomised Controlled Trial

  • Sponsor: Centre Hospitalier Universitaire de Rennes
  • Enrollment: 1680 (Estimated)
  • Study start: 2024-09-23 (Actual)
  • Primary completion: 2028-03-01 (Estimated)
  • Study completion: 2028-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: As part of this project, we are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort. This research will therefore consist of 3 complementary studies : A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups: * Group 1: laparoscopic robot-assisted hysterectomy * Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma

Intervention / Treatment

  • Procedure: Robot-assisted laparoscopy
  • Procedure: conventional laparoscopy
  • Other: Prospective cohort study
  • Other: Retrospective cohort study
  • Other: information and consent
  • Other: randomization
  • Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
  • Other: Surgical data collection
  • Other: Biological data collection
  • Other: Collection of histological data from the surgical specimen
  • Other: Phone calls
  • Other: Pain assessment
  • Other: Collect of data on non-reimbursed transport
  • Other: Collect of everyday help
  • Other: Collection of the business resumption date
  • Other: SF36 questionnaire
  • Other: Questionnaire EQ5D-5L
  • Other: FIGO Stadium
  • Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
  • Other: Collection of adjuvant treatments
  • Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
  • Other: Collection of data

Primary Outcome Measures

  • Cost-utility ratio expressed in terms of costs / QALY (6 weeks post-operatively)
    Incremental cost-utility ratio expressed in terms of costs / QALY (Quality-Adjusted Life-Year) gained with robot-assisted laparoscopy versus conventional laparoscopy in patients undergoing THR for low-risk or intermediate-risk endometrial carcinoma (i. e ; endometrioid adenocarcinoma of the endometrium grade 1 or 2 and FIGO stage 1 (FIGO 2023 classification)) in pre-therapeutic MRI) following a collective perspective at 6 weeks post-operatively.

Countries

France

Locations and Investigators

  • CHU de Lille, Hôpital Jeanne de Flandre, Lille, France (Not yet recruiting)
    • Yohan Kerbage
  • CHU LIMOGES, Hôpital Mère-Enfant, Limoges, France (Recruiting)
  • Hôpital Lariboisière/Hôpital Saint Louis, Paris, France (Not yet recruiting)
  • Hôpital Cochin, Paris, France (Not yet recruiting)
    • Bruno Borghese
  • Hôpital Européen Georges Pompidou, Paris, France (Recruiting)
  • Hôpital Bichat, Paris, France (Not yet recruiting)
  • Hôpital Tenon AP-HP, Paris, France (Not yet recruiting)
  • Hôpital Pitié Salpêtrière, Paris, France (Not yet recruiting)
  • Hôpital Lyon Sud - Hospices Civils de Lyon, Pierre-Bénite, France (Recruiting)
  • Hôpital privé des côtes d'Armor, Plérin, France (Not yet recruiting)
    • Isabelle Jaffré
  • CHU de Rennes, Rennes, France (Recruiting)
  • CHU de Rouen, Rouen, France (Recruiting)
    • Morgane Perrin
  • CHU de Saint Etienne, Saint-Etienne, France (Not yet recruiting)
  • CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg, France (Not yet recruiting)
  • CHU de Tours - Hôpital Bretonneau, Tours, France (Not yet recruiting)