Trial Title:
Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.
NCT ID:
NCT06348719
Condition:
Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
Conditions: Official terms:
Endometrial Neoplasms
Analgesics
Anticoagulants
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Robot-assisted laparoscopy
Description:
The experimental procedure corresponds to robot-assisted laparoscopy.
Arm group label:
Randomized study: Robot-assisted laparoscopy
Intervention type:
Procedure
Intervention name:
conventional laparoscopy
Description:
The "control" procedure corresponds to conventional laparoscopy.
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Prospective cohort study
Description:
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.
Arm group label:
Prospective cohort study
Intervention type:
Other
Intervention name:
Retrospective cohort study
Description:
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.
Arm group label:
Retrospective cohort study
Intervention type:
Other
Intervention name:
information and consent
Description:
information and consent
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Arm group label:
Retrospective cohort study
Intervention type:
Other
Intervention name:
randomization
Description:
Randomization
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence
Description:
Collection of socio-demographic, clinical, biological, imaging and histopathological
data, treatment decision, recurrence
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Surgical data collection
Description:
Surgical data collection at Day 0
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Biological data collection
Description:
Biological data collection at Day 1
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collection of histological data from the surgical specimen
Description:
Collection of histological data from the surgical specimen et Day 42
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Phone calls
Description:
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Pain assessment
Description:
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collect of data on non-reimbursed transport
Description:
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month
3, month 6
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collect of everyday help
Description:
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month
6
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collection of the business resumption date
Description:
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3,
month 6
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
SF36 questionnaire
Description:
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Questionnaire EQ5D-5L
Description:
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
FIGO Stadium
Description:
FIGO Stadium at inclusion and Day 42
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
Description:
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
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collection of adjuvant treatments
Description:
Collection of adjuvant treatments at month 6
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Description:
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
Arm group label:
Prospective cohort study
Arm group label:
Randomized study: Robot-assisted laparoscopy
Arm group label:
Randomized study: conventional laparoscopy
Intervention type:
Other
Intervention name:
Collection of data
Description:
Collection of data on age, baseline, BMI, histological type of cancer and surgical
approach used
Arm group label:
Retrospective cohort study
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
Criteria for eligibility:
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)
according to 2016 ESMO-ESGO-ESTRO recommendations, i.e. patients with
endometrioid-type endometrial cancer grade 1 or 2 and pre-therapeutic FIGO stage on
MRI Ia or Ib (i. i.e. myometrial infiltration of less than 50% or more than 50%
without involvement of the serosa or cervix, respectively).
- Indication for minimally invasive STH (laparoscopy) given by the surgeon during the
pre-op consultation.
- Patient operated with one of the intuitive robot variants (Si, X and Xi) 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.
- 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)
according to 2016 ESMO-ESGO-ESTRO recommendations, i.e. patient with
endometrioid-type endometrial cancer grade 1 or 2 and pre-therapeutic FIGO stage on
MRI Ia or Ib (i. i.e. myometrial infiltration of less than 50% or more than 50%
without involvement of the serosa or cervix, respectively).
- Indication for minimally invasive STH (laparoscopy) given by the surgeon during the
pre-op consultation.
- Patient operated with one of the intuitive robot variants (Si, X and Xi)
- 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 (≥ 30 cases of
robotic surgery in the last year and/or with total robotic experience ≥ 50
procedures)
- 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)
according to 2016 ESMO-ESGO-ESTRO recommendations, i.e. patient with
endometrioid-type endometrial cancer grade 1 or 2 and pre-therapeutic FIGO stage on
MRI Ia or Ib (i. i.e. myometrial infiltration of less than 50% or more than 50%
without involvement of the serosa or cervix, respectively).
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Lille, Hôpital Jeanne de Flandre
Address:
City:
Lille
Zip:
59000
Country:
France
Contact:
Last name:
Yohan Kerbage
Facility:
Name:
CHU LIMOGES, Hôpital Mère-Enfant
Address:
City:
Limoges
Zip:
87042
Country:
France
Facility:
Name:
Hôpital Lariboisière/Hôpital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Contact:
Last name:
Cyrille Huchon
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Contact:
Last name:
Bruno Borghese
Facility:
Name:
Hôpital Européen Georges Pompidou
Address:
City:
Paris
Zip:
75015
Country:
France
Contact:
Last name:
Henri Azaïs
Facility:
Name:
Hôpital Bichat
Address:
City:
Paris
Zip:
75018
Country:
France
Contact:
Last name:
Martin Koskas
Facility:
Name:
Hôpital Tenon AP-HP
Address:
City:
Paris
Zip:
75020
Country:
France
Contact:
Last name:
Yohann Dabi
Facility:
Name:
Hôpital Pitié Salpêtrière
Address:
City:
Paris
Country:
France
Facility:
Name:
Hôpital Lyon Sud - Hospices Civils de Lyon
Address:
City:
Pierre-Bénite
Zip:
69495
Country:
France
Contact:
Last name:
Pierre-Adrien Bolze
Facility:
Name:
Hôpital privé des côtes d'Armor
Address:
City:
Plerin
Zip:
22190
Country:
France
Contact:
Last name:
Isabelle Jaffré
Facility:
Name:
CHU de Rennes, Hôpital Sud
Address:
City:
Rennes
Zip:
35200
Country:
France
Contact:
Last name:
Vincent Lavoue
Facility:
Name:
CHU de Rouen
Address:
City:
Rouen
Zip:
76031
Country:
France
Contact:
Last name:
Morgane Perrin
Facility:
Name:
CHU de Saint Etienne
Address:
City:
Saint Etienne
Zip:
42055
Country:
France
Contact:
Last name:
Céline Chauleur
Facility:
Name:
CHU de Strasbourg - Hôpital de Hautepierre
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Facility:
Name:
CHU de Tours - Hôpital Bretonneau
Address:
City:
Tours
Zip:
37044
Country:
France
Contact:
Last name:
Lobna OULDAMER
Start date:
April 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Rennes University Hospital
Agency class:
Other
Source:
Rennes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348719
