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

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.

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