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

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

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