Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
Conditions
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
Interventions
PROCEDURERobot-assisted laparoscopy
The experimental procedure corresponds to robot-assisted laparoscopy.
PROCEDUREconventional laparoscopy
The control procedure corresponds to conventional laparoscopy.
OTHERCollection of adjuvant treatments
Collection of adjuvant treatments at month 6
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 surgery. These patients will be followed in exactly the same way as patients included in the randomized controlled trial, once their consent has been obtained.
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.
OTHERinformation and consent
information and consent
OTHERrandomization
Randomization
OTHERCollection 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
OTHERSurgical data collection
Surgical data collection at Day 0
OTHERBiological data collection
Biological data collection at Day 1
OTHERCollection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
OTHERPhone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
OTHERPain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
OTHERCollect of data on non-reimbursed transport
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
OTHERCollect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
OTHERCollection of the business resumption date
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
OTHERSF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
OTHERQuestionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
OTHERFIGO Stadium
FIGO Stadium at inclusion and Day 42
OTHERCollection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
OTHERRecording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one at Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
OTHERCollection of data
Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate and nature of intraoperative complications | Day 0 | Rate and nature of intraoperative complications |
| Operating time | Day 0 | Operating time |
| 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 D14 after surgery | Day 14 | Analgesic consumption at D14 after surgery |
| Analgesic consumption at D21 after surgery | Day 21 | Analgesic consumption at D21 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 health |
| EQ-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 health |
| EQ-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 health |
| EQ-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 health |
| EQ-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 health |
| EQ-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 health |
| EQ-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 health |
| EQ-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 health |
| EQ-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 health |
| SF-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). |
| Vital status at 6 months | Month 6 | Patient alive or not at 6 months |
| 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). |
| Conversion rate | month 6 | Conversion rate |
| 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 at the end of the operation using the NASA-TLX | Day 0 | Assessment of the surgeon's physical stress at the end of the operation using the NASA-TLX |
| Assessment of the First surgical assistant in the operating room's physical stress at the end of the operation using the NASA-TLX | Day 0 | Assessment of the First surgical assistant in the operating room's physical stress at the end of the operation using the NASA-TLX |
| Assessment of the First surgical assistant in the operating room's physical stress during and at the end of the operation using the Borg-Scale | Day 0 | Assessment of the First surgical assistant in the operating room's physical stress during and at the end of the operation using the Borg-Scale. On a scale of 0 to 10, with 0 representing no effort and 10 representing very intense (near-maximum) effort, how would you rate your current perception of the effort required for the surgical procedure? (0: No effort; 1: Very, very easy; 2: Very easy; 3: Easy; 4: Moderate effort; 5: Average; 6: A little hard; 7: Hard; 8: Very hard; 9: Very, very hard; 10: Maximum) Legs; Back; Neck; Left shoulder; Right shoulder; Left forearm; Right forearm; Left wrist; Right wrist; Left hand; Right hand; Left fingers; Right fingers |
| 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. |
| 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 |
Countries
France
Contacts
Primary ContactVincent Lavoué
Outcome results
None listed