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

NCT06348719 · Rennes University Hospital · Updated 15 Sept 2025

What is being tested
Robot-assisted laparoscopy; conventional laparoscopy; Prospective cohort study; Retrospective cohort study; information and consent; randomization; Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence; Surgical data collection; Biological data collection; Collection of histological data from the surgical specimen; Phone calls; Pain assessment; Collect of data on non-reimbursed transport; Collect of everyday help; Collection of the business resumption date; SF36 questionnaire; Questionnaire EQ5D-5L; FIGO Stadium; Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.); Collection of adjuvant treatments; Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one; Collection of data
For
Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 1,680 people. The full rules are on the registry page.
Where
France (15 sites)
When
Starts or started 23 Sept 2024, ends March 2028. Registered 5 April 2024.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06348719

Sites

  • CHU de Lille, Hôpital Jeanne de FlandreLille, France
  • CHU LIMOGES, Hôpital Mère-EnfantLimoges, France
  • Hôpital Lariboisière/Hôpital Saint LouisParis, France
  • Hôpital CochinParis, France
  • Hôpital Européen Georges PompidouParis, France
  • Hôpital BichatParis, France
  • Hôpital Tenon AP-HPParis, France
  • Hôpital Pitié SalpêtrièreParis, France
  • Hôpital Lyon Sud - Hospices Civils de LyonPierre-Bénite, France
  • Hôpital privé des côtes d'ArmorPlérin, France
  • CHU de RennesRennes, France
  • CHU de RouenRouen, France
  • CHU de Saint EtienneSaint-Etienne, France
  • CHU de Strasbourg - Hôpital de HautepierreStrasbourg, France
  • CHU de Tours - Hôpital BretonneauTours, France