Comparing robot-assisted and conventional laparoscopy for hysterectomy in endometrial cancer

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

This study is testing whether robot-assisted surgery is better and more cost-effective than traditional surgery for women with low- or intermediate-risk endometrial cancer who need a hysterectomy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1680 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Rennes University Hospital (Academic / other)
• Locations: 15 sites (Lille and 14 other locations)
• Trial ID: NCT06348719 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and cost of robot-assisted laparoscopy versus conventional laparoscopy for hysterectomy in patients with low- or intermediate-risk endometrial cancer. It employs a multicenter, parallel-group, open-label, randomized controlled trial design, alongside prospective and retrospective cohorts to gather comprehensive data. The research aims to assess not only surgical outcomes but also the perceptions of surgical teams regarding robotic surgery. The findings could provide insights into the efficiency and economic impact of robotic assistance in gynecological surgeries.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with low- or intermediate-risk endometrial carcinoma who are eligible for minimally invasive surgery.

Not a fit: Patients with high-risk endometrial carcinoma or those whose surgeons lack sufficient robotic surgery experience may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and cost-effectiveness for patients undergoing hysterectomy for endometrial cancer.

How similar studies have performed: Previous studies have indicated potential advantages of robotic surgery in gynecology, suggesting that this approach may yield positive results.

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) , 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

Where this trial is running

Lille and 14 other locations

• CHU de Lille, Hôpital Jeanne de Flandre — Lille, France (Not_yet_recruiting)
• CHU LIMOGES, Hôpital Mère-Enfant — Limoges, France (Recruiting)
• Hôpital Lariboisière/Hôpital Saint Louis — Paris, France (Not_yet_recruiting)
• Hôpital Cochin — Paris, France (Not_yet_recruiting)
• Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
• Hôpital Bichat — Paris, France (Not_yet_recruiting)
• Hôpital Tenon AP-HP — Paris, France (Not_yet_recruiting)
• Hôpital Pitié Salpêtrière — Paris, France (Not_yet_recruiting)
• Hôpital Lyon Sud - Hospices Civils de Lyon — Pierre-Bénite, France (Recruiting)
• Hôpital privé des côtes d'Armor — Plérin, France (Not_yet_recruiting)
• CHU de Rennes — Rennes, France (Recruiting)
• CHU de Rouen — Rouen, France (Recruiting)
• CHU de Saint Etienne — Saint-Etienne, France (Not_yet_recruiting)
• CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg, France (Not_yet_recruiting)
• CHU de Tours - Hôpital Bretonneau — Tours, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Vincent Lavoué

Conditions Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma