AzTrials
AzTrials

Hysterectomies for Low- or Intermediate-risk Endometrial CarcinomaROBOT-ECO-GYNNCT06348719

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

A study testing Robot-assisted laparoscopy, conventional laparoscopy and Prospective cohort study in people with Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma, run by Rennes University Hospital at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Robot-assisted laparoscopy, conventional laparoscopy and Prospective cohort study
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,680 participants
Where
15 sitesFrance
Study dates
23 Sep 2024to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 48Show fewer
  • 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
  • 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
  • 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 :
  • 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 :
  • 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

Who cannot join

  • 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:
  • 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:

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vincent Lavoué contact

02 99 26 59.71 ext. +33

Vincent.LAVOUE@chu-rennes.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • CHU de Lille, Hôpital Jeanne de Flandre

    Lille, 59000

    Yohan Kerbage

    Not yet recruiting

  • CHU LIMOGES, Hôpital Mère-Enfant

    Limoges, 87042

    Tristan Gauthier

    Recruiting

  • Hôpital Lariboisière/Hôpital Saint Louis

    Paris, 75010

    Cyrille Huchon

    Not yet recruiting

  • Hôpital Cochin

    Paris, 75014

    Bruno Borghese

    Not yet recruiting

  • Hôpital Européen Georges Pompidou

    Paris, 75015

    Henri Azaïs

    Recruiting

  • Hôpital Bichat

    Paris, 75018

    Martin Koskas

    Not yet recruiting

  • Hôpital Tenon AP-HP

    Paris, 75020

    Yohann Dabi

    Not yet recruiting

  • Hôpital Pitié Salpêtrière

    Paris

    Geoffroy Canlorbe

    Not yet recruiting

  • Hôpital Lyon Sud - Hospices Civils de Lyon

    Pierre-Bénite, 69495

    Pierre-Adrien Bolze

    Recruiting

  • Hôpital privé des côtes d'Armor

    Plérin, 22190

    Isabelle Jaffré

    Not yet recruiting

  • CHU de Rennes

    Rennes, 35200

    Vincent Lavoue

    Recruiting

  • CHU de Rouen

    Rouen, 76031

    Morgane Perrin

    Recruiting

  • CHU de Saint Etienne

    Saint-Etienne, 42055

    Céline Chauleur

    Not yet recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200

    Cherif Akladios

    Not yet recruiting

  • CHU de Tours - Hôpital Bretonneau

    Tours, 37044

    Lobna OULDAMER

    Not yet recruiting

Other trials in France

About this study

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

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.

Read more

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.

Read the 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

Being tested
Robot-assisted laparoscopy, conventional laparoscopy, Prospective cohort study, Retrospective cohort study, information and consent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted laparoscopyProcedure or surgery

    The experimental procedure corresponds to robot-assisted laparoscopy.

  • conventional laparoscopyProcedure or surgery

    The "control" procedure corresponds to conventional laparoscopy.

  • Prospective cohort studyOther

    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 studyOther

    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 consentOther

    information and consent

  • randomizationOther

    Randomization

  • Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrenceOther

    Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence

  • Surgical data collectionOther

    Surgical data collection at Day 0

  • Biological data collectionOther

    Biological data collection at Day 1

  • Collection of histological data from the surgical specimenOther

    Collection of histological data from the surgical specimen et Day 42

  • Phone callsOther

    Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3

  • Pain assessmentOther

    Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3

  • Collect of data on non-reimbursed transportOther

    Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6

  • Collect of everyday helpOther

    Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6

  • Collection of the business resumption dateOther

    Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6

  • SF36 questionnaireOther

    SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6

  • Questionnaire EQ5D-5LOther

    Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6

  • FIGO StadiumOther

    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 treatmentsOther

    Collection of adjuvant treatments at month 6

  • Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial oneOther

    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 dataOther

    Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used

Study groups in NCT06348719
Study groupRoleWhat they receive
Randomized study: Robot-assisted laparoscopyExperimentalRobot-assisted laparoscopic hysterectomy
Receives: Procedure: Robot-assisted laparoscopy; Other: information and consent; Other: randomization; Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence; Other: Surgical data collection; Other: Biological data collection; Other: Collection of histological data from the surgical specimen; Other: Phone calls; Other: Pain assessment; Other: Collect of data on non-reimbursed transport; Other: Collect of everyday help; Other: Collection of the business resumption date; Other: SF36 questionnaire; Other: Questionnaire EQ5D-5L; Other: FIGO Stadium; Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.); Other: Collection of adjuvant treatments; Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Randomized study: conventional laparoscopyActive comparatorConventional laparoscopic hysterectomy
Receives: Procedure: conventional laparoscopy; Other: information and consent; Other: randomization; Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence; Other: Surgical data collection; Other: Biological data collection; Other: Collection of histological data from the surgical specimen; Other: Phone calls; Other: Pain assessment; Other: Collect of data on non-reimbursed transport; Other: Collect of everyday help; Other: Collection of the business resumption date; Other: SF36 questionnaire; Other: Questionnaire EQ5D-5L; Other: FIGO Stadium; Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.); Other: Collection of adjuvant treatments; Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Prospective cohort studyOtherProspective 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).
Receives: Other: Prospective cohort study; Other: information and consent; Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence; Other: Surgical data collection; Other: Biological data collection; Other: Collection of histological data from the surgical specimen; Other: Phone calls; Other: Pain assessment; Other: Collect of data on non-reimbursed transport; Other: Collect of everyday help; Other: Collection of the business resumption date; Other: SF36 questionnaire; Other: Questionnaire EQ5D-5L; Other: FIGO Stadium; Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.); Other: Collection of adjuvant treatments; Other: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
Retrospective cohort studyOthera 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.
Receives: Other: Retrospective cohort study; Other: information and consent; Other: Collection of data

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks post-operatively

Secondary outcomes (50)

  1. Operating time

    Operating time

    Measured: Day 0

  2. Conversion rate

    Conversion rate

    Measured: month 6

  3. Rate and nature of intraoperative complications

    Rate and nature of intraoperative complications

    Measured: Day 0

  4. Post-operative complication rate and nature at D42 (Clavien-Dindo classification)

    Post-operative complication rate and nature at D42 (Clavien-Dindo classification)

    Measured: Day 42

  5. Post-operative complication rate and nature at M6 (Clavien-Dindo classification)

    Post-operative complication rate and nature at M6 (Clavien-Dindo classification)

    Measured: Month 6

  6. Volume of intraoperative blood loss

    Volume of intraoperative blood loss

    Measured: Day 0

  7. 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

    Measured: Day 3

  8. 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

    Measured: 6 Hours after surgery

  9. 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

    Measured: 24 Hours after surgery

  10. 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

    Measured: Day 3

  11. Analgesic consumption at D1 after surgery

    Analgesic consumption at D1 after surgery

    Measured: Day 1

  12. Analgesic consumption at D3 after surgery

    Analgesic consumption at D3 after surgery

    Measured: Day 3

  13. Analgesic consumption at D7 after surgery

    Analgesic consumption at D7 after surgery

    Measured: Day 7

  14. Analgesic consumption at D14 after surgery

    Analgesic consumption at D14 after surgery

    Measured: Day 14

  15. Analgesic consumption at D21 after surgery

    Analgesic consumption at D21 after surgery

    Measured: Day 21

  16. Analgesic consumption at D42 after surgery

    Analgesic consumption at D42 after surgery

    Measured: Day 42

  17. 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

    Measured: Day 0

  18. 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

    Measured: Day 1

  19. 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

    Measured: Day 3

  20. 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

    Measured: Day 7

  21. 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

    Measured: Day 14

  22. 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

    Measured: Day 21

  23. 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

    Measured: Day 42

  24. 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

    Measured: Month 3

  25. 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

    Measured: Month 6

  26. 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.

    Measured: Day 0

  27. 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.

    Measured: Day 3

  28. 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.

    Measured: Day 7

  29. 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.

    Measured: Day 42

  30. 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.

    Measured: Month 6

  31. Consumption of care: average length of hospital stay

    Consumption of care between surgery and D42 and M6: average length of hospital stay in days

    Measured: Day 42

  32. Consumption of care: average of number of re-hospitalizations,

    Consumption of care between surgery and D42 and M6: average of number of re-hospitalizations

    Measured: Day 42

  33. Consumption of care: average of emergency room visits

    Consumption of care between surgery and D42 and M6: average of emergency room visits

    Measured: Day 42

  34. Consumption of care: average of number of gynecologist consultations

    Consumption of care between surgery and D42 and M6: average of number of gynecologist consultations

    Measured: Day 42

  35. 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

    Measured: Day 42

  36. Consumption of care:

    Consumption of care between surgery and D42 and M6: quantity of consumption of anticoagulant(s) up to D42

    Measured: Day 42

  37. 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).

    Measured: Day 42

  38. Time to initiate adjuvant treatment when indicated

    Time to initiate adjuvant treatment when indicated (radiotherapy and/or brachytherapy and/or chemotherapy).

    Measured: Month 6

  39. Vital status at 6 months

    Patient alive or not at 6 months

    Measured: Month 6

  40. Gas recovery time

    Gas recovery time

    Measured: Day 3

  41. 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<or≥ at 75 and BMI<or≥ at 30 kg/m2,

    Measured: Day 42

  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.

    Measured: Month 6

  43. 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.

    Measured: Month 36

  44. 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 (<or≥ to 75 years) and BMI <or≥ to 30 kg/m2).

    Measured: Month 36

  45. 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

    Measured: Month 36

  46. 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

    Measured: Day 0

  47. 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

    Measured: Day 0

  48. 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

    Measured: Day 0

  49. 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

    Measured: Day 0

  50. 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.

    Measured: Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start23 Sep 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
1,680 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06348719
Sponsor's protocol ID
35RC21_9732_ROBOT-ECO-GYN
Acronym
ROBOT-ECO-GYN
Status last verified
Aug 2025
First submitted
19 Mar 2024
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted laparoscopy, conventional laparoscopy and Prospective cohort study in people with Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma, run by Rennes University Hospital at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincent Lavoué (02 99 26 59.71 ext. +33, Vincent.LAVOUE@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-utility ratio expressed in terms of costs / QALY (time frame: 6 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06348719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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