Robot vs. surgeon: which is better for uterine cancer surgery?
NCT ID NCT06348719
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study compares two types of minimally invasive surgery for early-stage endometrial cancer: robot-assisted laparoscopy and conventional laparoscopy. About 1,680 patients will be randomly assigned to one of the two procedures. The goal is to see which approach offers better value for money and quality of life after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- robot-assisted laparoscopy
- What this could lead to
- If robot-assisted surgery proves more cost-effective, it could become the preferred option for endometrial cancer hysterectomy, potentially improving recovery and quality of life.
- What could go wrong
- This is a cost-effectiveness study, not a test of a new cure. Results may vary by patient age and weight, and the robot's higher upfront cost might not justify small benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,680 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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) , 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 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 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: None
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
15 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU LIMOGES, Hôpital Mère-Enfant
RECRUITINGLimoges, 87042, France
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CHU de Lille, Hôpital Jeanne de Flandre
NOT_YET_RECRUITINGLille, 59000, France
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CHU de Rennes
RECRUITINGRennes, 35200, France
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CHU de Rouen
RECRUITINGRouen, 76031, France
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CHU de Saint Etienne
NOT_YET_RECRUITINGSaint-Etienne, 42055, France
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CHU de Strasbourg - Hôpital de Hautepierre
NOT_YET_RECRUITINGStrasbourg, 67200, France
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CHU de Tours - Hôpital Bretonneau
NOT_YET_RECRUITINGTours, 37044, France
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Hôpital Bichat
NOT_YET_RECRUITINGParis, 75018, France
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Hôpital Cochin
NOT_YET_RECRUITINGParis, 75014, France
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Hôpital Européen Georges Pompidou
RECRUITINGParis, 75015, France
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Hôpital Lariboisière/Hôpital Saint Louis
NOT_YET_RECRUITINGParis, 75010, France
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Hôpital Lyon Sud - Hospices Civils de Lyon
RECRUITINGPierre-Bénite, 69495, France
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Hôpital Pitié Salpêtrière
NOT_YET_RECRUITINGParis, France
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Hôpital Tenon AP-HP
NOT_YET_RECRUITINGParis, 75020, France
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Hôpital privé des côtes d'Armor
NOT_YET_RECRUITINGPlérin, 22190, France
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Other studies related to the condition(s) this trial covers.
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