Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
- Conditions
- Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
- Registration Number
- NCT06348719
- Lead Sponsor
- Rennes University Hospital
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1680
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cost-utility ratio expressed in terms of costs / QALY 6 weeks post-operatively Incremental cost-utility ratio expressed in terms of costs / QALY (Quality-Adjusted Life-Year) gained with robot-assisted laparoscopy versus conventional laparoscopy in patients undergoing THR for low-risk or intermediate-risk endometrial carcinoma (i. e ; endometrioid adenocarcinoma of the endometrium grade 1 or 2 and FIGO stage 1 ((FIGO 2023 classification) in pre-therapeutic MRI) following a collective perspective at 6 weeks post-operatively.
- Secondary Outcome Measures
Name Time Method Operating time Day 0 Operating time
Conversion rate month 6 Conversion rate
Rate and nature of intraoperative complications Day 0 Rate and nature of intraoperative complications
Post-operative complication rate and nature at D42 (Clavien-Dindo classification) Day 42 Post-operative complication rate and nature at D42 (Clavien-Dindo classification)
Post-operative complication rate and nature at M6 (Clavien-Dindo classification) Month 6 Post-operative complication rate and nature at M6 (Clavien-Dindo classification)
Volume of intraoperative blood loss Day 0 Volume of intraoperative blood loss
Number of RBC, FFP, PC transfused during hospital stay Day 3 Number of Red Blood Cell Concentrate(s) (RBC), Fresh Frozen Plasma(s) (FFP), and Platelet Concentrate(s) (PC) transfused during hospital stay
Visual analogue scale (VAS) of pain 6h after surgery 6 Hours after surgery Visual analogue evaluation (VAS) of pain 6h after surgery. Scale from 0 to 10. VAS between 1 and 3: pain of mild intensity VAS between 3 and 5: pain of moderate intensity VAS between 5 and 7: intense pain VAS greater than 7: very intense pain
Visual analogue scale (VAS) of pain 24h after surgery 24 Hours after surgery Visual analogue scale (VAS) of pain 24h after surgery. Scale from 0 to 10. VAS between 1 and 3: pain of mild intensity VAS between 3 and 5: pain of moderate intensity VAS between 5 and 7: intense pain VAS greater than 7: very intense pain
Visual analogue scale (VAS) of pain D3 after surgery Day 3 Visual analogue scale (VAS) of pain D3 after surgery. Scale from 0 to 10. VAS between 1 and 3: pain of mild intensity VAS between 3 and 5: pain of moderate intensity VAS between 5 and 7: intense pain VAS greater than 7: very intense pain
Analgesic consumption at D1 after surgery Day 1 Analgesic consumption at D1 after surgery
Analgesic consumption at D3 after surgery Day 3 Analgesic consumption at D3 after surgery
Analgesic consumption at D7 after surgery Day 7 Analgesic consumption at D7 after surgery
Analgesic consumption at D42 after surgery Day 42 Analgesic consumption at D42 after surgery
EQ-5D-5L at inclusion after surgery Day 0 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at inclusion after surgery. Score from 0 to 1 - 0 = deceased
1 = in perfect healthEQ-5D-5L at D1 after surgery Day 1 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D1 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at D3 after surgery Day 3 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D3 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at D7 after surgery Day 7 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D7 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at D14 after surgery Day 14 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D14 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at D21 after surgery Day 21 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D21 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at D42 after surgery Day 42 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D42 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at M3 after surgery Month 3 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at M3 after surgery. Score from 0 to 1. 0 = deceased
1 = in perfect healthEQ-5D-5L at M6 after surgery Month 6 EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at M6 after surgery. Score from 0 to 1 0 = deceased
1 = in perfect healthSF-36 at baseline after surgery Day 0 SF-36 (Short Form 36) at baseline after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
SF-36 at D3 after surgery Day 3 SF-36 (Short Form 36) at D3 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
SF-36 at D7 after surgery Day 7 SF-36 (Short Form 36) at D7 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
SF-36 at D42 after surgery Day 42 SF-36 (Short Form 36) at D42 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
SF-36 at M6 after surgery Month 6 SF-36 (Short Form 36) at M6 after surgery. Score from 0 to 100. The higher the score, the better the quality of life.
Consumption of care: average length of hospital stay Day 42 Consumption of care between surgery and D42 and M6: average length of hospital stay in days
Consumption of care: average of number of re-hospitalizations, Day 42 Consumption of care between surgery and D42 and M6: average of number of re-hospitalizations
Consumption of care: average of emergency room visits Day 42 Consumption of care between surgery and D42 and M6: average of emergency room visits
Consumption of care: average of number of gynecologist consultations Day 42 Consumption of care between surgery and D42 and M6: average of number of gynecologist consultations
Consumption of care: quantity of analgesic(s) Day 42 Consumption of care between surgery and D42 and M6: quantity of consumption of analgesic(s) up to D42
Consumption of care: Day 42 Consumption of care between surgery and D42 and M6: quantity of consumption of anticoagulant(s) up to D42
Consumption of care: average of number of work stoppage(s). Day 42 Consumption of care between surgery and D42 and M6: average of number of work stoppage(s).
Time to initiate adjuvant treatment when indicated Month 6 Time to initiate adjuvant treatment when indicated (radiotherapy and/or brachytherapy and/or chemotherapy).
Gas recovery time Day 3 Gas recovery time
QALYs from a collective perspective at D42 Day 42 Incremental cost-utility ratio expressed as costs/QALYs gained with robot-assisted laparoscopy vs. laparoscopy from a collective perspective at D42, stratified by age\<or≥ at 75 and BMI\<or≥ at 30 kg/m2,
QALYs from a collective perspective at M6. Month 6 Incremental cost-utility ratio expressed as costs/QALYs gained with robot-assisted laparoscopy versus laparoscopy from a collective perspective at M6.
Number of patients who underwent each approach Month 36 Number of patients who underwent each approach (laparotomy, conventional laparoscopy, robotic-assisted laparoscopy or vaginal approach) among patients operated on for low- or intermediate-risk endometrial cancer at participating centers during the inclusion period.
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). Month 36 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).
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. Month 36 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. Use of semi directiv interview, qualitative method
Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale Day 0 Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale
Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX Day 0 Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX
Total annual costs of the foreseeable spread of robot-assisted surgery Month 36 Total annual costs of the foreseeable spread of robot-assisted surgery for low-risk or intermediate-risk endometrial cancer and of alternative management, with gradual generalization over a 5-year period, based on the outlook for the French healthcare system.
Vital status at 6 months Month 6 Patient alive or not at 6 months
Trial Locations
- Locations (15)
CHU de Lille, Hôpital Jeanne de Flandre
🇫🇷Lille, France
CHU LIMOGES, Hôpital Mère-Enfant
🇫🇷Limoges, France
Hôpital Lariboisière/Hôpital Saint Louis
🇫🇷Paris, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Bichat
🇫🇷Paris, France
Hôpital Tenon AP-HP
🇫🇷Paris, France
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
Hôpital Lyon Sud - Hospices Civils de Lyon
🇫🇷Pierre-Bénite, France
Hôpital privé des côtes d'Armor
🇫🇷Plerin, France
Scroll for more (5 remaining)CHU de Lille, Hôpital Jeanne de Flandre🇫🇷Lille, FranceYohan KerbageContact