1,680
Participants
Start Date
September 23, 2024
Primary Completion Date
March 31, 2028
Study Completion Date
March 31, 2028
Robot-assisted laparoscopy
The experimental procedure corresponds to robot-assisted laparoscopy.
conventional laparoscopy
"The control procedure corresponds to conventional laparoscopy."
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 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 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.
information and consent
information and consent
randomization
Randomization
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
Surgical data collection
Surgical data collection at Day 0
Biological data collection
Biological data collection at Day 1
Collection of histological data from the surgical specimen
Collection of histological data from the surgical specimen et Day 42
Phone calls
Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3
Pain assessment
Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3
Collect of data on non-reimbursed transport
Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Collect of everyday help
Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
Collection of the business resumption date
Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6
SF36 questionnaire
SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6
Questionnaire EQ5D-5L
Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6
FIGO Stadium
FIGO Stadium at inclusion and Day 42
Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)
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 treatments
Collection of adjuvant treatments at month 6
Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one
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 data
Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used
NOT_YET_RECRUITING
Hôpital privé des côtes d'Armor, Plérin
RECRUITING
CHU de Rennes, Rennes
NOT_YET_RECRUITING
CHU de Tours - Hôpital Bretonneau, Tours
NOT_YET_RECRUITING
CHU de Saint Etienne, Saint-Etienne
NOT_YET_RECRUITING
CHU de Lille, Hôpital Jeanne de Flandre, Lille
NOT_YET_RECRUITING
CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg
RECRUITING
Hôpital Lyon Sud - Hospices Civils de Lyon, Pierre-Bénite
NOT_YET_RECRUITING
Hôpital Lariboisière/Hôpital Saint Louis, Paris
NOT_YET_RECRUITING
Hôpital Cochin, Paris
RECRUITING
Hôpital Européen Georges Pompidou, Paris
NOT_YET_RECRUITING
Hôpital Bichat, Paris
NOT_YET_RECRUITING
Hôpital Tenon AP-HP, Paris
RECRUITING
CHU de Rouen, Rouen
RECRUITING
CHU LIMOGES, Hôpital Mère-Enfant, Limoges
NOT_YET_RECRUITING
Hôpital Pitié Salpêtrière, Paris
Rennes University Hospital
OTHER