Comparing robot-assisted and conventional laparoscopy for hysterectomy in endometrial cancer

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