NCT06348719招募中不适用
Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer: Multicentre Randomised Controlled Trial
Rennes University Hospital29 个研究点 分布在 1 个国家目标入组 1,680 人开始时间: 2024年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,680
- 试验地点
- 29
- 主要终点
- Cost-utility ratio expressed in terms of costs / QALY
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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:
- •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:
结局指标
主要结局
Cost-utility ratio expressed in terms of costs / QALY
时间窗: 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.
Cost-utility ratio expressed in terms of costs / QALY
时间窗: 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.
次要结局
- Operating time(Day 0)
- Conversion rate(month 6)
- Rate and nature of intraoperative complications(Day 0)
- Post-operative complication rate and nature at D42 (Clavien-Dindo classification)(Day 42)
- Post-operative complication rate and nature at M6 (Clavien-Dindo classification)(Month 6)
- Volume of intraoperative blood loss(Day 0)
- Number of RBC, FFP, PC transfused during hospital stay(Day 3)
- Visual analogue scale (VAS) of pain 6h after surgery(6 Hours after surgery)
- Visual analogue scale (VAS) of pain 24h after surgery(24 Hours after surgery)
- Visual analogue scale (VAS) of pain D3 after surgery(Day 3)
- Analgesic consumption at D1 after surgery(Day 1)
- Analgesic consumption at D3 after surgery(Day 3)
- Analgesic consumption at D7 after surgery(Day 7)
- Analgesic consumption at D14 after surgery(Day 14)
- Analgesic consumption at D21 after surgery(Day 21)
- Analgesic consumption at D42 after surgery(Day 42)
- EQ-5D-5L at inclusion after surgery(Day 0)
- EQ-5D-5L at D1 after surgery(Day 1)
- EQ-5D-5L at D3 after surgery(Day 3)
- EQ-5D-5L at D7 after surgery(Day 7)
- EQ-5D-5L at D14 after surgery(Day 14)
- EQ-5D-5L at D21 after surgery(Day 21)
- EQ-5D-5L at D42 after surgery(Day 42)
- EQ-5D-5L at M3 after surgery(Month 3)
- EQ-5D-5L at M6 after surgery(Month 6)
- SF-36 at baseline after surgery(Day 0)
- SF-36 at D3 after surgery(Day 3)
- SF-36 at D7 after surgery(Day 7)
- SF-36 at D42 after surgery(Day 42)
- SF-36 at M6 after surgery(Month 6)
- Consumption of care: average length of hospital stay(Day 42)
- Consumption of care: average of number of re-hospitalizations,(Day 42)
- Number of patients who underwent each approach(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).(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.(Month 36)
- 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(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(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(Day 0)
- Total annual costs of the foreseeable spread of robot-assisted surgery(Month 36)
- QALYs from a collective perspective at D42(Day 42)
- QALYs from a collective perspective at M6.(Month 6)
- Consumption of care: average of emergency room visits(Day 42)
- Consumption of care: average of number of gynecologist consultations(Day 42)
- Consumption of care: quantity of analgesic(s)(Day 42)
- Consumption of care:(Day 42)
- Consumption of care: average of number of work stoppage(s).(Day 42)
- Time to initiate adjuvant treatment when indicated(Month 6)
- Vital status at 6 months(Month 6)
- Gas recovery time(Day 3)
- Operating time(Day 0)
- Conversion rate(month 6)
- EQ-5D-5L at D21 after surgery(Day 21)
- Rate and nature of intraoperative complications(Day 0)
- Post-operative complication rate and nature at D42 (Clavien-Dindo classification)(Day 42)
- Post-operative complication rate and nature at M6 (Clavien-Dindo classification)(Month 6)
- Volume of intraoperative blood loss(Day 0)
- Number of RBC, FFP, PC transfused during hospital stay(Day 3)
- Visual analogue scale (VAS) of pain 6h after surgery(6 Hours after surgery)
- Visual analogue scale (VAS) of pain 24h after surgery(24 Hours after surgery)
- Visual analogue scale (VAS) of pain D3 after surgery(Day 3)
- Analgesic consumption at D1 after surgery(Day 1)
- Analgesic consumption at D3 after surgery(Day 3)
- Analgesic consumption at D7 after surgery(Day 7)
- Analgesic consumption at D14 after surgery(Day 14)
- Analgesic consumption at D21 after surgery(Day 21)
- Analgesic consumption at D42 after surgery(Day 42)
- EQ-5D-5L at inclusion after surgery(Day 0)
- EQ-5D-5L at D1 after surgery(Day 1)
- EQ-5D-5L at D3 after surgery(Day 3)
- EQ-5D-5L at D7 after surgery(Day 7)
- EQ-5D-5L at D14 after surgery(Day 14)
- EQ-5D-5L at D42 after surgery(Day 42)
- EQ-5D-5L at M3 after surgery(Month 3)
- EQ-5D-5L at M6 after surgery(Month 6)
- SF-36 at baseline after surgery(Day 0)
- SF-36 at D3 after surgery(Day 3)
- SF-36 at D7 after surgery(Day 7)
- SF-36 at D42 after surgery(Day 42)
- SF-36 at M6 after surgery(Month 6)
- Consumption of care: average length of hospital stay(Day 42)
- Consumption of care: average of number of re-hospitalizations,(Day 42)
- Consumption of care: average of emergency room visits(Day 42)
- Consumption of care: average of number of gynecologist consultations(Day 42)
- Consumption of care: quantity of analgesic(s)(Day 42)
- Consumption of care:(Day 42)
- Consumption of care: average of number of work stoppage(s).(Day 42)
- Time to initiate adjuvant treatment when indicated(Month 6)
- Vital status at 6 months(Month 6)
- Gas recovery time(Day 3)
- QALYs from a collective perspective at D42(Day 42)
- QALYs from a collective perspective at M6.(Month 6)
- Number of patients who underwent each approach(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).(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.(Month 36)
- 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(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(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(Day 0)
- Total annual costs of the foreseeable spread of robot-assisted surgery(Month 36)
研究者
研究点 (29)
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