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Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer. (ROBOT-ECO-GYN)

R

Rennes University Hospital

Status

Enrolling

Conditions

Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06348719
35RC21_9732_ROBOT-ECO-GYN

Details and patient eligibility

About

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.

Full description

As part of this project, the investigators 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 THR
  • Group 2: conventional laparoscopic STH A prospective cohort based on the randomized controlled trial A retrospective cohort Qualitative analysis of perceptions of the benefits and limitations of the surgical robot, and of the obstacles and levers to its deployment: focus groups with a sample of gynecology surgical teams from volunteer centers.

Budget impact analysis

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Enrollment

1,680 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Randomized Study:

Inclusion Criteria:

  • Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patients with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI.
  • Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.
  • Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS)
  • Major patient.
  • Patient having received information on the protocol and having signed a consent form, thus accepting randomization in the robot-assisted intervention group versus conventional laparoscopy.

Non Inclusion Criteria:

  • Patient operated on by a surgeon with less than 30 cases of robotic surgery in the last year and/or with less than 50 cases of total robotic experience at the time of patient inclusion.
  • Patient refuses to participate in randomized controlled trial (refuses randomization)
  • The surgeon refuses the patient's participation in the randomized controlled trial (does not wish to randomize the patient).
  • The center does not have a robot
  • The center does not have a laparoscopic column with fluorescence
  • Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;
  • Patient not affiliated to a French social security scheme
  • Patient participating in another interventional trial or in Jardé off-label research that impacts study data, or in RIPH3 that impacts study data
  • Pregnant or breast-feeding patient

Exclusion criteria :

  • Minimally invasive procedure contraindicated by pre-operative anesthesia.
  • Patient operated on by a robot other than one of the intuitive robot variants (Si, X and Xi).

Prospective cohort:

Inclusion Criteria:

  • Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patient with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI .

  • Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.

  • Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS)

  • Major patient.

  • Patient not included in randomized controlled trial because :

    • Patient refuses to participate in randomized controlled trial (refusing randomization)
    • The surgeon refuses the patient's participation in the randomized controlled trial (does not wish to randomize the patient)
    • The center does not have a robot
    • The center does not have a laparoscopic column with fluorescence
    • The surgeon does not meet the required learning curve criteria (as a reminder: ≥ 30 cases of robotic surgery in the last year and with total robotic experience ≥ 50 procedures ) at the time of patient inclusion

  • Patient has been informed about the protocol and has signed a consent form.

Non Inclusion Criteria:

  • Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;
  • Patient not affiliated to a French social security scheme
  • Patient participating in another interventional trial or in Jardé off-label research that impacts study data, or in RIPH3 that impacts study data
  • Pregnant or breast-feeding patient

Exclusion criteria :

  • Minimally invasive procedure contraindicated by pre-operative anesthesia.
  • Patient operated on by a robot other than one of the intuitive robot variants (Si, X and Xi).

Retrospective cohort:

Inclusion Criteria:

  • Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patient with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI).
  • STH performed during the inclusion period of the randomized controlled trial and/or the prospective cohortat a participating center, regardless of the approach used, not included in the randomized controlled trial and in the prospective cohort.
  • Patient not objecting to the collection and use of her data
  • Patient of legal age.

Non Inclusion Criteria:

  • Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;
  • Patient not affiliated to a French social security scheme

Surgeons :

Inclusion Criteria:

  • Surgeon performing hysterectomy on patients included in the randomized study and/or prospective cohort
  • Surgeon not objecting to the collection and use of his data

Non- inclusion Criteria:

None

First surgical assistance in the field :

Inclusion Criteria:

  • First surgical assistance in the field performing hysterectomy on patients included in the randomized study and/or prospective cohort
  • First surgical assistance in the field not objecting to the collection and use of his data

Non- inclusion Criteria:

None

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,680 participants in 4 patient groups

Randomized study: Robot-assisted laparoscopy
Experimental group
Description:
Robot-assisted laparoscopic hysterectomy
Treatment:
Other: Collect of everyday help
Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Other: Questionnaire EQ5D-5L
Other: FIGO Stadium
Procedure: Robot-assisted laparoscopy
Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Other: Collection of adjuvant treatments
Other: SF36 questionnaire
Other: Phone calls
Other: Biological data collection
Other: randomization
Other: information and consent
Other: Collection of histological data from the surgical specimen
Other: Collection of the business resumption date
Other: Collect of data on non-reimbursed transport
Other: Pain assessment
Other: Surgical data collection
Randomized study: conventional laparoscopy
Active Comparator group
Description:
Conventional laparoscopic hysterectomy
Treatment:
Other: Collect of everyday help
Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Other: Questionnaire EQ5D-5L
Other: FIGO Stadium
Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Other: Collection of adjuvant treatments
Procedure: conventional laparoscopy
Other: SF36 questionnaire
Other: Phone calls
Other: Biological data collection
Other: randomization
Other: information and consent
Other: Collection of histological data from the surgical specimen
Other: Collection of the business resumption date
Other: Collect of data on non-reimbursed transport
Other: Pain assessment
Other: Surgical data collection
Prospective cohort study
Other group
Description:
Prospective cohort study backed by randomized controlled trial (for patients not included in the trial due to surgeon refusal, absence of learning curve criteria for the surgeon or patient refusal, center unable to participate in the randomized study).
Treatment:
Other: Collect of everyday help
Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Other: Questionnaire EQ5D-5L
Other: FIGO Stadium
Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Other: Collection of adjuvant treatments
Other: SF36 questionnaire
Other: Phone calls
Other: Biological data collection
Other: information and consent
Other: Prospective cohort study
Other: Collection of histological data from the surgical specimen
Other: Collection of the business resumption date
Other: Collect of data on non-reimbursed transport
Other: Pain assessment
Other: Surgical data collection
Retrospective cohort study
Other group
Description:
a retrospective cohort will be set up to provide an exhaustive overview of the approaches used for endometrial cancer, according to patient characteristics (age and BMI). It will include all patients not included in the randomized controlled trial and in the prospective cohort because the surgeon did not propose it to them, because they did not wish to be followed up for the study for 6 months, or because the surgeon considered that minimally invasive surgery was not indicated; up to a limit of 1000 inclusions.
Treatment:
Other: Collection of data
Other: information and consent
Other: Retrospective cohort study

Trial contacts and locations

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Central trial contact

Vincent Lavoué

Data sourced from clinicaltrials.gov

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