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

March 29, 2024 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

1680

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59000
        • CHU de Lille, Hôpital Jeanne de Flandre
        • Contact:
          • Yohan Kerbage
      • Limoges, France, 87042
        • CHU LIMOGES, Hôpital Mère-Enfant
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
        • Contact:
          • Henri Azaïs
      • Paris, France, 75014
        • Hôpital COCHIN
        • Contact:
          • Bruno Borghese
      • Paris, France
        • Hopital Pitie Salpetriere
      • Paris, France, 75018
        • Hôpital Bichat
        • Contact:
          • Martin Koskas
      • Paris, France, 75020
        • Hôpital Tenon AP-HP
        • Contact:
          • Yohann Dabi
      • Paris, France, 75010
        • Hôpital Lariboisière/Hôpital Saint Louis
        • Contact:
          • Cyrille Huchon
      • Pierre-Bénite, France, 69495
        • Hôpital Lyon Sud - Hospices Civils de Lyon
        • Contact:
          • Pierre-Adrien Bolze
      • Plerin, France, 22190
        • Hôpital Privé des Côtes d'Armor
        • Contact:
          • Isabelle Jaffré
      • Rennes, France, 35200
        • CHU de Rennes, Hôpital Sud
        • Contact:
          • Vincent Lavoue
      • Rouen, France, 76031
        • CHU de Rouen
        • Contact:
          • Morgane Perrin
      • Saint Etienne, France, 42055
        • CHU de Saint Etienne
        • Contact:
          • Céline Chauleur
      • Strasbourg, France, 67200
        • CHU de Strasbourg - Hôpital de Hautepierre
      • Tours, France, 37044
        • CHU de Tours - Hôpital Bretonneau
        • Contact:
          • Lobna OULDAMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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) according to 2016 ESMO-ESGO-ESTRO recommendations, i.e. patients with endometrioid-type endometrial cancer grade 1 or 2 and pre-therapeutic FIGO stage on MRI Ia or Ib (i. i.e. myometrial infiltration of less than 50% or more than 50% without involvement of the serosa or cervix, respectively).
  • Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.
  • Patient operated with one of the intuitive robot variants (Si, X and Xi) 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.
  • 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 a non-observational trial
  • 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) according to 2016 ESMO-ESGO-ESTRO recommendations, i.e. patient with endometrioid-type endometrial cancer grade 1 or 2 and pre-therapeutic FIGO stage on MRI Ia or Ib (i. i.e. myometrial infiltration of less than 50% or more than 50% without involvement of the serosa or cervix, respectively).
  • Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.
  • Patient operated with one of the intuitive robot variants (Si, X and Xi)
  • 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 (≥ 30 cases of robotic surgery in the last year and/or with total robotic experience ≥ 50 procedures)
  • 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 a non-observational trial
  • 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) according to 2016 ESMO-ESGO-ESTRO recommendations, i.e. patient with endometrioid-type endometrial cancer grade 1 or 2 and pre-therapeutic FIGO stage on MRI Ia or Ib (i. i.e. myometrial infiltration of less than 50% or more than 50% without involvement of the serosa or cervix, respectively).
  • STH performed during the inclusion period of the randomized controlled trial at a participating center, regardless of the approach used, not included in the randomized controlled trial or 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomized study: Robot-assisted laparoscopy
Robot-assisted laparoscopic hysterectomy
Procedure: Robot-assisted laparoscopy
The experimental procedure corresponds to robot-assisted laparoscopy.
Other: information and consent
information and consent
Other: randomization
Randomization
Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other: Surgical data collection
Surgical data collection at Day 0
Other: Biological data collection
Biological data collection at Day 1
Other: Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Other: Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Other: Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Other: Collect of data on non-reimbursed transport
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: Collection of the business resumption date
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Other: Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: FIGO Stadium
FIGO Stadium at inclusion and Day 42
Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one at Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Active Comparator: Randomized study: conventional laparoscopy
Conventional laparoscopic hysterectomy
Other: information and consent
information and consent
Other: randomization
Randomization
Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other: Surgical data collection
Surgical data collection at Day 0
Other: Biological data collection
Biological data collection at Day 1
Other: Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Other: Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Other: Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Other: Collect of data on non-reimbursed transport
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: Collection of the business resumption date
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Other: Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: FIGO Stadium
FIGO Stadium at inclusion and Day 42
Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one at Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Procedure: conventional laparoscopy
The "control" procedure corresponds to conventional laparoscopy.
Other: Prospective cohort study
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).
Other: information and consent
information and consent
Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Other: Surgical data collection
Surgical data collection at Day 0
Other: Biological data collection
Biological data collection at Day 1
Other: Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Other: Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Other: Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Other: Collect of data on non-reimbursed transport
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: Collection of the business resumption date
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Other: SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Other: Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: FIGO Stadium
FIGO Stadium at inclusion and Day 42
Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one at Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Other: Prospective cohort study
A prospective cohort of patients will be set up to support the randomized controlled trial. Patients will be offered participation in this cohort if the center is unable to participate in the randomized trial (i.e., does not have a robot, or does not have a laparoscopic column with fluorescence), if the patient refuses randomization in the randomized controlled trial, if the surgeon refuses to randomize the patient, or if the surgeon does not meet the learning curve criteria required for robotic surgery. These patients will be followed in exactly the same way as patients included in the randomized controlled trial, once their consent has been obtained.
Other: Retrospective cohort study
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.
Other: information and consent
information and consent
Other: Retrospective cohort study
Retrospective data collection from the medical records of all patients who underwent hysterectomy for low- or intermediate-risk endometrial cancer during the inclusion period at a participating center and who were not included in the randomized controlled trial or prospective cohort; up to a limit of 1000 inclusions. For this retrospective cohort, only data concerning initial age, BMI, histological type of cancer and surgical approach used will be collected.
Other: Collection of data
Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-utility ratio expressed in terms of costs / QALY
Time Frame: 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 Ia or IB (i.e ; < or > 50% of myometrium) without pre-therapeutic emboli) following a collective perspective at 6 weeks post-operatively.
6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: Day 0
Operating time
Day 0
Conversion rate
Time Frame: month 6
Conversion rate
month 6
Rate and nature of intraoperative complications
Time Frame: Day 0
Rate and nature of intraoperative complications
Day 0
Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
Time Frame: Day 42
Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
Day 42
Post-operative complication rate and nature at M6 (Clavien-Dindo classification)
Time Frame: Month 6
Post-operative complication rate and nature at M6 (Clavien-Dindo classification)
Month 6
Volume of intraoperative blood loss
Time Frame: Day 0
Volume of intraoperative blood loss
Day 0
Number of RBC, FFP, PC transfused during hospital stay
Time Frame: Day 3
Number of Red Blood Cell Concentrate(s) (RBC), Fresh Frozen Plasma(s) (FFP), and Platelet Concentrate(s) (PC) transfused during hospital stay
Day 3
Visual analogue scale (VAS) of pain 6h after surgery
Time Frame: 6 Hours after surgery
Visual analogue evaluation (VAS) of pain 6h after surgery. Scale from 0 to 10. VAS between 1 and 3: pain of mild intensity VAS between 3 and 5: pain of moderate intensity VAS between 5 and 7: intense pain VAS greater than 7: very intense pain
6 Hours after surgery
Visual analogue scale (VAS) of pain 24h after surgery
Time Frame: 24 Hours after surgery
Visual analogue scale (VAS) of pain 24h after surgery. Scale from 0 to 10. VAS between 1 and 3: pain of mild intensity VAS between 3 and 5: pain of moderate intensity VAS between 5 and 7: intense pain VAS greater than 7: very intense pain
24 Hours after surgery
Visual analogue scale (VAS) of pain D3 after surgery
Time Frame: Day 3
Visual analogue scale (VAS) of pain D3 after surgery. Scale from 0 to 10. VAS between 1 and 3: pain of mild intensity VAS between 3 and 5: pain of moderate intensity VAS between 5 and 7: intense pain VAS greater than 7: very intense pain
Day 3
Analgesic consumption at D1 after surgery
Time Frame: Day 1
Analgesic consumption at D1 after surgery
Day 1
Analgesic consumption at D3 after surgery
Time Frame: Day 3
Analgesic consumption at D3 after surgery
Day 3
Analgesic consumption at D7 after surgery
Time Frame: Day 7
Analgesic consumption at D7 after surgery
Day 7
Analgesic consumption at D42 after surgery
Time Frame: Day 42
Analgesic consumption at D42 after surgery
Day 42
EQ-5D-5L at inclusion after surgery
Time Frame: Day 0

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at inclusion after surgery. Score from 0 to 1 - 0 = deceased

1 = in perfect health
Day 0
EQ-5D-5L at D1 after surgery
Time Frame: Day 1

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D1 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Day 1
EQ-5D-5L at D3 after surgery
Time Frame: Day 3

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D3 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Day 3
EQ-5D-5L at D7 after surgery
Time Frame: Day 7

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D7 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Day 7
EQ-5D-5L at D14 after surgery
Time Frame: Day 14

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D14 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Day 14
EQ-5D-5L at D21 after surgery
Time Frame: Day 21

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D21 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Day 21
EQ-5D-5L at D42 after surgery
Time Frame: Day 42

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D42 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Day 42
EQ-5D-5L at M3 after surgery
Time Frame: Month 3

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at M3 after surgery. Score from 0 to 1. 0 = deceased

1 = in perfect health
Month 3
EQ-5D-5L at M6 after surgery
Time Frame: Month 6

EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at M6 after surgery. Score from 0 to 1 0 = deceased

1 = in perfect health
Month 6
SF-36 at baseline after surgery
Time Frame: Day 0
SF-36 (Short Form 36) at baseline after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
Day 0
SF-36 at D3 after surgery
Time Frame: Day 3
SF-36 (Short Form 36) at D3 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
Day 3
SF-36 at D7 after surgery
Time Frame: Day 7
SF-36 (Short Form 36) at D7 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
Day 7
SF-36 at D42 after surgery
Time Frame: Day 42
SF-36 (Short Form 36) at D42 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
Day 42
SF-36 at M6 after surgery
Time Frame: Month 6
SF-36 (Short Form 36) at M6 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
Month 6
Consumption of care: average length of hospital stay
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: average length of hospital stay in days
Day 42
Consumption of care: average of number of re-hospitalizations,
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: average of number of re-hospitalizations
Day 42
Consumption of care: average of emergency room visits
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: average of emergency room visits
Day 42
Consumption of care: average of number of gynecologist consultations
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: average of number of gynecologist consultations
Day 42
Consumption of care: quantity of analgesic(s)
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: quantity of consumption of analgesic(s) up to D42
Day 42
Consumption of care:
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: quantity of consumption of anticoagulant(s) up to D42
Day 42
Consumption of care: average of number of work stoppage(s).
Time Frame: Day 42
Consumption of care between surgery and D42 and M6: average of number of work stoppage(s).
Day 42
Time to initiate adjuvant treatment when indicated
Time Frame: Month 6
Time to initiate adjuvant treatment when indicated (radiotherapy and/or brachytherapy and/or chemotherapy).
Month 6
Vital status at 6 months
Time Frame: Month 6
Patient alive or not at 6 months
Month 6
Gas recovery time
Time Frame: Day 3
Gas recovery time
Day 3
QALYs from a collective perspective at D42
Time Frame: Day 42
Incremental cost-utility ratio expressed as costs/QALYs gained with robot-assisted laparoscopy vs. laparoscopy from a collective perspective at D42, stratified by age<or>at 75 and BMI<or>at 30 kg/m2,
Day 42
QALYs from a collective perspective at M6.
Time Frame: Month 6
Incremental cost-utility ratio expressed as costs/QALYs gained with robot-assisted laparoscopy versus laparoscopy from a collective perspective at M6.
Month 6
Number of patients who underwent each approach
Time Frame: Month 36
Number of patients who underwent each approach (laparotomy, conventional laparoscopy, robotic-assisted laparoscopy or vaginal approach) among patients operated on for low- or intermediate-risk endometrial cancer at participating centers during the inclusion period.
Month 36
QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2).
Time Frame: Month 36
QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2).
Month 36
Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer.
Time Frame: Month 36
Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer. Use of semi directiv interview, qualitative method
Month 36
Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale
Time Frame: Day 0
Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale
Day 0
Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX
Time Frame: Day 0
Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX
Day 0
Total annual costs of the foreseeable spread of robot-assisted surgery
Time Frame: Month 36
Total annual costs of the foreseeable spread of robot-assisted surgery for low-risk or intermediate-risk endometrial cancer and of alternative management, with gradual generalization over a 5-year period, based on the outlook for the French healthcare system.
Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC21_9732_ROBOT-ECO-GYN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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