Идёт набор NCT06348719

Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.

Без фазы С лечением Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Robot-assisted laparoscopy, conventional laparoscopy, Prospective cohort study, Retrospective cohort study.
Кому может быть актуально: Состояния в реестре: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer: Multicentre Randomised Controlled Trial

Обзор

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.

Подробное описание

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

Вмешательства

Процедура Robot-assisted laparoscopy
The experimental procedure corresponds to robot-assisted laparoscopy.
Процедура conventional laparoscopy
The "control" procedure corresponds to conventional laparoscopy.
Другое Prospective cohort study
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
Другое Retrospective cohort study
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.
Другое information and consent
information and consent
Другое randomization
Randomization
Другое Collection 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
Другое Surgical data collection
Surgical data collection at Day 0
Другое Biological data collection
Biological data collection at Day 1
Другое Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42

Первичные конечные точки

Cost-utility ratio expressed in terms of costs / QALY [Срок оценки: 6 weeks post-operatively]

Вторичные конечные точки (12)

Operating time [Срок оценки: Day 0]
Conversion rate [Срок оценки: month 6]
Rate and nature of intraoperative complications [Срок оценки: Day 0]
Post-operative complication rate and nature at D42 (Clavien-Dindo classification) [Срок оценки: Day 42]
Post-operative complication rate and nature at M6 (Clavien-Dindo classification) [Срок оценки: Month 6]
Volume of intraoperative blood loss [Срок оценки: Day 0]
Number of RBC, FFP, PC transfused during hospital stay [Срок оценки: Day 3]
Visual analogue scale (VAS) of pain 6h after surgery [Срок оценки: 6 Hours after surgery]
Visual analogue scale (VAS) of pain 24h after surgery [Срок оценки: 24 Hours after surgery]
Visual analogue scale (VAS) of pain D3 after surgery [Срок оценки: Day 3]
Analgesic consumption at D1 after surgery [Срок оценки: Day 1]
Analgesic consumption at D3 after surgery [Срок оценки: Day 3]

Критерии участия

Randomized Study:

Критерии включения

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

Критерии исключения

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:

Критерии включения

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

Критерии исключения

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:

Критерии включения

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

Surgeons :

Критерии включения

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

First surgical assistance in the field :

Критерии включения

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:

None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет