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

NARecruitingINTERVENTIONAL
Enrollment

1,680

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma
Interventions
PROCEDURE

Robot-assisted laparoscopy

The experimental procedure corresponds to robot-assisted laparoscopy.

PROCEDURE

conventional laparoscopy

"The control procedure corresponds to conventional laparoscopy."

OTHER

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.

OTHER

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.

OTHER

information and consent

information and consent

OTHER

randomization

Randomization

OTHER

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

OTHER

Surgical data collection

Surgical data collection at Day 0

OTHER

Biological data collection

Biological data collection at Day 1

OTHER

Collection of histological data from the surgical specimen

Collection of histological data from the surgical specimen et Day 42

OTHER

Phone calls

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

OTHER

Pain assessment

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

OTHER

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

OTHER

Collect of everyday help

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

OTHER

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

OTHER

SF36 questionnaire

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

OTHER

Questionnaire EQ5D-5L

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

OTHER

FIGO Stadium

FIGO Stadium at inclusion and Day 42

OTHER

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

OTHER

Collection of adjuvant treatments

Collection of adjuvant treatments at month 6

OTHER

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

OTHER

Collection of data

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

Trial Locations (15)

22190

NOT_YET_RECRUITING

Hôpital privé des côtes d'Armor, Plérin

35200

RECRUITING

CHU de Rennes, Rennes

37044

NOT_YET_RECRUITING

CHU de Tours - Hôpital Bretonneau, Tours

42055

NOT_YET_RECRUITING

CHU de Saint Etienne, Saint-Etienne

59000

NOT_YET_RECRUITING

CHU de Lille, Hôpital Jeanne de Flandre, Lille

67200

NOT_YET_RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg

69495

RECRUITING

Hôpital Lyon Sud - Hospices Civils de Lyon, Pierre-Bénite

75010

NOT_YET_RECRUITING

Hôpital Lariboisière/Hôpital Saint Louis, Paris

75014

NOT_YET_RECRUITING

Hôpital Cochin, Paris

75015

RECRUITING

Hôpital Européen Georges Pompidou, Paris

75018

NOT_YET_RECRUITING

Hôpital Bichat, Paris

75020

NOT_YET_RECRUITING

Hôpital Tenon AP-HP, Paris

76031

RECRUITING

CHU de Rouen, Rouen

87042

RECRUITING

CHU LIMOGES, Hôpital Mère-Enfant, Limoges

Unknown

NOT_YET_RECRUITING

Hôpital Pitié Salpêtrière, Paris

All Listed Sponsors
lead

Rennes University Hospital

OTHER