Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
NCT ID: NCT06348719
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1680 participants
INTERVENTIONAL
2024-09-23
2028-03-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
OTHER
NONE
Study Groups
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Randomized study: Robot-assisted laparoscopy
Robot-assisted laparoscopic hysterectomy
Robot-assisted laparoscopy
The experimental procedure corresponds to robot-assisted laparoscopy.
information and consent
information and consent
randomization
Randomization
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
Surgical data collection
Surgical data collection at Day 0
Biological data collection
Biological data collection at Day 1
Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
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
Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
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
SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium
FIGO Stadium at inclusion and Day 42
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
Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
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
Randomized study: conventional laparoscopy
Conventional laparoscopic hysterectomy
conventional laparoscopy
The "control" procedure corresponds to conventional laparoscopy.
information and consent
information and consent
randomization
Randomization
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
Surgical data collection
Surgical data collection at Day 0
Biological data collection
Biological data collection at Day 1
Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
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
Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
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
SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium
FIGO Stadium at inclusion and Day 42
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
Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
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
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).
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.
information and consent
information and consent
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
Surgical data collection
Surgical data collection at Day 0
Biological data collection
Biological data collection at Day 1
Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
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
Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
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
SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium
FIGO Stadium at inclusion and Day 42
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
Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
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
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.
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.
information and consent
information and consent
Collection of data
Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used
Interventions
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Robot-assisted laparoscopy
The experimental procedure corresponds to robot-assisted laparoscopy.
conventional laparoscopy
The "control" procedure corresponds to conventional laparoscopy.
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.
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.
information and consent
information and consent
randomization
Randomization
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
Surgical data collection
Surgical data collection at Day 0
Biological data collection
Biological data collection at Day 1
Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
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
Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
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
SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium
FIGO Stadium at inclusion and Day 42
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
Collection of adjuvant treatments
Collection of adjuvant treatments at month 6
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
Collection of data
Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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
* 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.
* Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;
* Patient not affiliated to a French social security scheme
Surgeons :
* 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
None
First surgical assistance in the field :
* 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
None
Exclusion Criteria
* Patient operated on by a robot other than one of the intuitive robot variants (Si, X and Xi).
Prospective cohort:
* 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:
18 Years
FEMALE
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CHU de Lille, Hôpital Jeanne de Flandre
Lille, , France
CHU LIMOGES, Hôpital Mère-Enfant
Limoges, , France
Hôpital Lariboisière/Hôpital Saint Louis
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Bichat
Paris, , France
Hôpital Tenon AP-HP
Paris, , France
Hôpital Pitié Salpêtrière
Paris, , France
Hôpital Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, , France
Hôpital privé des côtes d'Armor
Plérin, , France
CHU de Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
CHU de Saint Etienne
Saint-Etienne, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
CHU de Tours - Hôpital Bretonneau
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Yohan Kerbage
Role: primary
Tristan Gauthier
Role: primary
Cyrille Huchon
Role: primary
Bruno Borghese
Role: primary
Henri Azaïs
Role: primary
Martin Koskas
Role: primary
Yohann Dabi
Role: primary
Geoffroy Canlorbe
Role: primary
Pierre-Adrien Bolze
Role: primary
Isabelle Jaffré
Role: primary
Vincent Lavoue
Role: primary
Morgane Perrin
Role: primary
Céline Chauleur
Role: primary
Cherif Akladios
Role: primary
Lobna OULDAMER
Role: primary
Other Identifiers
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35RC21_9732_ROBOT-ECO-GYN
Identifier Type: -
Identifier Source: org_study_id
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