Clinical trial NCT06348719: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 1680
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: As part of this project, we 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 hysterectomy
* Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort
Primary purpose: OTHER

Brief summary: 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

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 a non-observational trial
* 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 a non-observational trial
* 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 at a participating center, regardless of the approach used, not included in the randomized controlled trial or 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

Primary outcomes:
measure: Cost-utility ratio expressed in terms of costs / QALY
timeFrame: 6 weeks post-operatively
Secondary outcomes:
measure: Operating time
timeFrame: Day 0
measure: Conversion rate
timeFrame: month 6
measure: Rate and nature of intraoperative complications
timeFrame: Day 0
measure: Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
timeFrame: Day 42
measure: Post-operative complication rate and nature at M6 (Clavien-Dindo classification)
timeFrame: Month 6
measure: Volume of intraoperative blood loss
timeFrame: Day 0
measure: Number of RBC, FFP, PC transfused during hospital stay
timeFrame: Day 3
measure: Visual analogue scale (VAS) of pain 6h after surgery
timeFrame: 6 Hours after surgery
measure: Visual analogue scale (VAS) of pain 24h after surgery
timeFrame: 24 Hours after surgery
measure: Visual analogue scale (VAS) of pain D3 after surgery
timeFrame: Day 3
measure: Analgesic consumption at D1 after surgery
timeFrame: Day 1
measure: Analgesic consumption at D3 after surgery
timeFrame: Day 3
measure: Analgesic consumption at D7 after surgery
timeFrame: Day 7
measure: Analgesic consumption at D42 after surgery
timeFrame: Day 42
measure: EQ-5D-5L at inclusion after surgery
timeFrame: Day 0
measure: EQ-5D-5L at D1 after surgery
timeFrame: Day 1
measure: EQ-5D-5L at D3 after surgery
timeFrame: Day 3
measure: EQ-5D-5L at D7 after surgery
timeFrame: Day 7
measure: EQ-5D-5L at D14 after surgery
timeFrame: Day 14
measure: EQ-5D-5L at D21 after surgery
timeFrame: Day 21
measure: EQ-5D-5L at D42 after surgery
timeFrame: Day 42
measure: EQ-5D-5L at M3 after surgery
timeFrame: Month 3
measure: EQ-5D-5L at M6 after surgery
timeFrame: Month 6
measure: SF-36 at baseline after surgery
timeFrame: Day 0
measure: SF-36 at D3 after surgery
timeFrame: Day 3
measure: SF-36 at D7 after surgery
timeFrame: Day 7
measure: SF-36 at D42 after surgery
timeFrame: Day 42
measure: SF-36 at M6 after surgery
timeFrame: Month 6
measure: Consumption of care: average length of hospital stay
timeFrame: Day 42
measure: Consumption of care: average of number of re-hospitalizations,
timeFrame: Day 42
measure: Consumption of care: average of emergency room visits
timeFrame: Day 42
measure: Consumption of care: average of number of gynecologist consultations
timeFrame: Day 42
measure: Consumption of care: quantity of analgesic(s)
timeFrame: Day 42
measure: Consumption of care:
timeFrame: Day 42
measure: Consumption of care: average of number of work stoppage(s).
timeFrame: Day 42
measure: Time to initiate adjuvant treatment when indicated
timeFrame: Month 6
measure: Vital status at 6 months
timeFrame: Month 6
measure: Gas recovery time
timeFrame: Day 3
measure: QALYs from a collective perspective at D42
timeFrame: Day 42
measure: QALYs from a collective perspective at M6.
timeFrame: Month 6
measure: Number of patients who underwent each approach
timeFrame: Month 36
measure: QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2).
timeFrame: Month 36
measure: Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer.
timeFrame: Month 36
measure: Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale
timeFrame: Day 0
measure: Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX
timeFrame: Day 0
measure: Total annual costs of the foreseeable spread of robot-assisted surgery
timeFrame: Month 36
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille, Hôpital Jeanne de Flandre
city: Limoges
country: France
facility: CHU LIMOGES, Hôpital Mère-Enfant
city: Paris
country: France
facility: Hôpital Lariboisière/Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Tenon AP-HP
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud - Hospices Civils de Lyon
city: Plerin
country: France
facility: Hôpital privé des côtes d'Armor
city: Rennes
country: France
facility: CHU de Rennes, Hôpital Sud
city: Rouen
country: France
facility: CHU de Rouen
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital de Hautepierre
city: Tours
country: France
facility: CHU de Tours - Hôpital Bretonneau
Study officials:
References: