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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.
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:
Budget impact analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized study: Robot-assisted laparoscopy | Experimental | Robot-assisted laparoscopic hysterectomy |
|
| Randomized study: conventional laparoscopy | Active Comparator | Conventional laparoscopic hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted laparoscopy | Procedure | The experimental procedure corresponds to robot-assisted laparoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost-utility ratio expressed in terms of costs / QALY | 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. | 6 weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Operating time | Day 0 |
| Conversion rate | Conversion rate | month 6 |
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Randomized Study:
Inclusion Criteria:
Non Inclusion Criteria:
Exclusion criteria :
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 has been informed about the protocol and has signed a consent form.
Non Inclusion Criteria:
Exclusion criteria :
Retrospective cohort:
Inclusion Criteria:
Non Inclusion Criteria:
Surgeons :
Inclusion Criteria:
Non- inclusion Criteria:
None
First surgical assistance in the field :
Inclusion Criteria:
Non- inclusion Criteria:
None
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Lavoué | Contact | 02 99 26 59.71 | +33 | Vincent.LAVOUE@chu-rennes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille, Hôpital Jeanne de Flandre | Not yet recruiting | Lille | 59000 | France |
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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:
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| Prospective cohort study | Other | Prospective cohort study backed by randomized controlled trial (for patients not included in the trial due to surgeon refusal, absence of learning curve criteria for the surgeon or patient refusal, center unable to participate in the randomized study). |
|
| Retrospective cohort study | Other | a retrospective cohort will be set up to provide an exhaustive overview of the approaches used for endometrial cancer, according to patient characteristics (age and BMI). It will include all patients not included in the randomized controlled trial and in the prospective cohort because the surgeon did not propose it to them, because they did not wish to be followed up for the study for 6 months, or because the surgeon considered that minimally invasive surgery was not indicated; up to a limit of 1000 inclusions. |
|
| conventional laparoscopy | Procedure | The "control" procedure corresponds to conventional laparoscopy. |
|
| Prospective cohort study | Other | 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 cohort study | Other | 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. |
|
| information and consent | Other | information and consent |
|
| randomization | Other | Randomization |
|
| Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence | Other | Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence |
|
| Surgical data collection | Other | Surgical data collection at Day 0 |
|
| Biological data collection | Other | Biological data collection at Day 1 |
|
| Collection of histological data from the surgical specimen | Other | Collection of histological data from the surgical specimen et Day 42 |
|
| Phone calls | Other | Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3 |
|
| Pain assessment | Other | Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3 |
|
| Collect of data on non-reimbursed transport | Other | Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6 |
|
| Collect of everyday help | Other | Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6 |
|
| Collection of the business resumption date | Other | Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6 |
|
| SF36 questionnaire | Other | SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6 |
|
| Questionnaire EQ5D-5L | Other | Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6 |
|
| FIGO Stadium | Other | FIGO Stadium at inclusion and Day 42 |
|
| Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) | Other | 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 |
|
| Collection of adjuvant treatments | Other | Collection of adjuvant treatments at month 6 |
|
| Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one | Other | 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 |
|
| Collection of data | Other | Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used |
|
| Rate and nature of intraoperative complications | Rate and nature of intraoperative complications | Day 0 |
| Post-operative complication rate and nature at D42 (Clavien-Dindo classification) | Post-operative complication rate and nature at D42 (Clavien-Dindo classification) | Day 42 |
| Post-operative complication rate and nature at M6 (Clavien-Dindo classification) | Post-operative complication rate and nature at M6 (Clavien-Dindo classification) | Month 6 |
| Volume of intraoperative blood loss | Volume of intraoperative blood loss | Day 0 |
| Number of RBC, FFP, PC transfused during hospital stay | Number of Red Blood Cell Concentrate(s) (RBC), Fresh Frozen Plasma(s) (FFP), and Platelet Concentrate(s) (PC) transfused during hospital stay | Day 3 |
| Visual analogue scale (VAS) of pain 6h 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 | 6 Hours after surgery |
| Visual analogue scale (VAS) of pain 24h 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 | 24 Hours after surgery |
| Visual analogue scale (VAS) of pain D3 after surgery | 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 | Day 3 |
| Analgesic consumption at D1 after surgery | Analgesic consumption at D1 after surgery | Day 1 |
| Analgesic consumption at D3 after surgery | Analgesic consumption at D3 after surgery | Day 3 |
| Analgesic consumption at D7 after surgery | Analgesic consumption at D7 after surgery | Day 7 |
| Analgesic consumption at D14 after surgery | Analgesic consumption at D14 after surgery | Day 14 |
| Analgesic consumption at D21 after surgery | Analgesic consumption at D21 after surgery | Day 21 |
| Analgesic consumption at D42 after surgery | Analgesic consumption at D42 after surgery | Day 42 |
| EQ-5D-5L at inclusion after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at inclusion after surgery. Score from 0 to 1 - 0 = deceased 1 = in perfect health | Day 0 |
| EQ-5D-5L at D1 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D1 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Day 1 |
| EQ-5D-5L at D3 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D3 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Day 3 |
| EQ-5D-5L at D7 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D7 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Day 7 |
| EQ-5D-5L at D14 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D14 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Day 14 |
| EQ-5D-5L at D21 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D21 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Day 21 |
| EQ-5D-5L at D42 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at D42 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Day 42 |
| EQ-5D-5L at M3 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at M3 after surgery. Score from 0 to 1. 0 = deceased 1 = in perfect health | Month 3 |
| EQ-5D-5L at M6 after surgery | EQ-5D-5L (Euroquol - 5 Dimensions - 5 levels) at M6 after surgery. Score from 0 to 1 0 = deceased 1 = in perfect health | Month 6 |
| SF-36 at baseline after surgery | SF-36 (Short Form 36) at baseline after surgery. Score from 0 to 100. The higher the score, the better the quality of life. | Day 0 |
| SF-36 at D3 after surgery | SF-36 (Short Form 36) at D3 after surgery. Score from 0 to 100. The higher the score, the better the quality of life. | Day 3 |
| SF-36 at D7 after surgery | SF-36 (Short Form 36) at D7 after surgery. Score from 0 to 100. The higher the score, the better the quality of life. | Day 7 |
| SF-36 at D42 after surgery | SF-36 (Short Form 36) at D42 after surgery. Score from 0 to 100. The higher the score, the better the quality of life. | Day 42 |
| SF-36 at M6 after surgery | SF-36 (Short Form 36) at M6 after surgery. Score from 0 to 100. The higher the score, the better the quality of life. | Month 6 |
| Consumption of care: average length of hospital stay | Consumption of care between surgery and D42 and M6: average length of hospital stay in days | Day 42 |
| Consumption of care: average of number of re-hospitalizations, | Consumption of care between surgery and D42 and M6: average of number of re-hospitalizations | Day 42 |
| Consumption of care: average of emergency room visits | Consumption of care between surgery and D42 and M6: average of emergency room visits | Day 42 |
| Consumption of care: average of number of gynecologist consultations | Consumption of care between surgery and D42 and M6: average of number of gynecologist consultations | Day 42 |
| Consumption of care: quantity of analgesic(s) | Consumption of care between surgery and D42 and M6: quantity of consumption of analgesic(s) up to D42 | Day 42 |
| Consumption of care: | Consumption of care between surgery and D42 and M6: quantity of consumption of anticoagulant(s) up to D42 | Day 42 |
| Consumption of care: average of number of work stoppage(s). | Consumption of care between surgery and D42 and M6: average of number of work stoppage(s). | Day 42 |
| Time to initiate adjuvant treatment when indicated | Time to initiate adjuvant treatment when indicated (radiotherapy and/or brachytherapy and/or chemotherapy). | Month 6 |
| Vital status at 6 months | Patient alive or not at 6 months | Month 6 |
| Gas recovery time | Gas recovery time | Day 3 |
| QALYs from a collective perspective at D42 | Incremental cost-utility ratio expressed as costs/QALYs gained with robot-assisted laparoscopy vs. laparoscopy from a collective perspective at D42, stratified by age\ | Day 42 |
| QALYs from a collective perspective at M6. | Incremental cost-utility ratio expressed as costs/QALYs gained with robot-assisted laparoscopy versus laparoscopy from a collective perspective at M6. | Month 6 |
| Number of patients who underwent each approach | 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. | 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). | 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 (\ | 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. | 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 | Month 36 |
| 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 Borg scale | Day 0 |
| Assessment of the surgeon's physical stress at the end of the operation using the NASA-TLX | Assessment of the surgeon'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 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 during and at the end of the operation using the Borg-Scale | 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 | Day 0 |
| Total annual costs of the foreseeable spread of robot-assisted surgery | 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. | Month 36 |
| CHU LIMOGES, Hôpital Mère-Enfant | Recruiting | Limoges | 87042 | France |
|
| Hôpital Lariboisière/Hôpital Saint Louis | Not yet recruiting | Paris | 75010 | France |
|
| Hôpital Cochin | Not yet recruiting | Paris | 75014 | France |
|
| Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
|
| Hôpital Bichat | Not yet recruiting | Paris | 75018 | France |
|
| Hôpital Tenon AP-HP | Not yet recruiting | Paris | 75020 | France |
|
| Hôpital Pitié Salpêtrière | Not yet recruiting | Paris | France |
|
| Hôpital Lyon Sud - Hospices Civils de Lyon | Recruiting | Pierre-Bénite | 69495 | France |
|
| Hôpital privé des côtes d'Armor | Not yet recruiting | Plérin | 22190 | France |
|
| CHU de Rennes | Recruiting | Rennes | 35200 | France |
|
| CHU de Rouen | Recruiting | Rouen | 76031 | France |
|
| CHU de Saint Etienne | Not yet recruiting | Saint-Etienne | 42055 | France |
|
| CHU de Strasbourg - Hôpital de Hautepierre | Not yet recruiting | Strasbourg | 67200 | France |
|
| CHU de Tours - Hôpital Bretonneau | Not yet recruiting | Tours | 37044 | France |
|
| ID | Term |
|---|---|
| D011446 | Prospective Studies |
| D032962 | Consent Forms |
| D011897 | Random Allocation |
| D001688 | Biological Products |
| D014965 | X-Rays |
| D000700 | Analgesics |
| D000096924 | Emergency Room Visits |
| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D007258 | Informed Consent |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
| D015340 | Epidemiologic Research Design |
| D012107 | Research Design |
| D008722 | Methods |
| D045424 | Complex Mixtures |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D005791 | Patient Care |
| D000078336 | Facilities and Services Utilization |
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