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

Official title

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

Overview

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.

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

Interventions

• Procedure Robot-assisted laparoscopy
  The experimental procedure corresponds to robot-assisted laparoscopy.
• Procedure conventional laparoscopy
  The "control" procedure corresponds to conventional laparoscopy.
• 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
• 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 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

Primary outcome measures

• Cost-utility ratio expressed in terms of costs / QALY [Time frame: 6 weeks post-operatively]

Secondary outcome measures (12)

• Operating time [Time frame: Day 0]
• Conversion rate [Time frame: month 6]
• Rate and nature of intraoperative complications [Time frame: Day 0]
• Post-operative complication rate and nature at D42 (Clavien-Dindo classification) [Time frame: Day 42]
• Post-operative complication rate and nature at M6 (Clavien-Dindo classification) [Time frame: Month 6]
• Volume of intraoperative blood loss [Time frame: Day 0]
• Number of RBC, FFP, PC transfused during hospital stay [Time frame: Day 3]
• Visual analogue scale (VAS) of pain 6h after surgery [Time frame: 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 D3 after surgery [Time frame: Day 3]
• Analgesic consumption at D1 after surgery [Time frame: Day 1]
• Analgesic consumption at D3 after surgery [Time frame: Day 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 15 centers

• CHU de Lille, Hôpital Jeanne de Flandre — Lille
• CHU LIMOGES, Hôpital Mère-Enfant — Limoges
• Hôpital Lariboisière/Hôpital Saint Louis — Paris
• Hôpital Cochin — Paris
• Hôpital Européen Georges Pompidou — Paris
• Hôpital Bichat — Paris
• Hôpital Tenon AP-HP — Paris
• Hôpital Pitié Salpêtrière — Paris
• … and 7 more centers

Identifiers

NCT: NCT06348719 · 35RC21_9732_ROBOT-ECO-GYN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗