Endometriosis
Conditions
Brief summary
The purpose of this study is to compare the robot-assisted approach with the laparoscopic approach in terms of reducing the rates of intraoperative and postoperative complications in patients undergoing total hysterectomy for DIE and adenomyosis without digestive tract involvement.
Detailed description
The ENDO-RAS trial aims to evaluate the safety and effectiveness of robot-assisted laparoscopy compared to conventional laparoscopy for hysterectomy in patients with Deep infiltrating endometriosis and adenomyosis without digestive tract involvement, as verified by magnetic resonance imaging and classified using both the ENZIAN and Deep Pelvic Endometriosis Index classifications. These classifications are used to evaluate Deep infiltrating endometriosis and reproducibly predict the occurrence of postoperative complications. Eligible patients will be recruited from the gynecological surgery department after meeting the inclusion and non-inclusion criteria and signed informed consent forms. Participants will then be randomly assigned to receive either robot-assisted total laparoscopic hysterectomy or total laparoscopic hysterectomy. The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study. Eligible patients will be randomized into two parallel groups.
Interventions
PROCEDURETotal Laparoscopic Hysterectomy
The standard procedure for performing total hysterectomy will also follow the Querleu and Morrow classification system, which divides the procedure into four types based on the extent of resection: * Type A: minimum resection of paracervix. * Type B: transection of the paracervix and the ureter. * Type C: Transection of paracervix at the junction with the internal iliac vascular system * Type D: Laterally extended resection. Furthermore, bilateral ureterolysis will be performed with the option of bilateral concomitant salpingo-oophorectomy.
DEVICEUreterolysis
unilateral or bilateral ureterolysis with or without bilateral adnexectomy
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Euraxi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study.
Intervention model description
Eligible patients will be randomized into two parallel groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age. * Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) per the Enzian and dPEI classifications. * Diagnosed deep infiltrating endometriosis per the Enzian and dPEI classifications, without the involvement of the digestive tract. * Failure of first- and second-line medical treatment. * Eligibility for total hysterectomy with complete removal of endometriosis lesions. * Participants covered by entitled to social security. * All participants must provide written informed consent before undergoing the surgical procedure.
Exclusion criteria
* Digestive tract involvement. * Adenomyosis only. * Contraindications to surgery. * Participants who are under guardianship, curatorship, or deprivation of liberty.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra and post-operative complication rates | 3 months | Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Questionnaires NASA-TLX | Day 0 (surgery) | Perceived exertion by surgeons of laparoscopic and robotic intervention. |
| Short Form Health Survey (SF-36) | At baseline and at 3, 6, and 12 month. | Patients' quality of life COmpletion of hte Endometriosis-related quality of life |
| Patients' sexual quality of life | At baseline and at 3, 6, and 12 months. | Completion of the Sexual quality-of-life using the Female Sexual Function Index (FSFI) A 19-point questionnaire with a scale from 0 to 5. |
| Duration of the intervention | Time from incision to closure (12 months) | The mean operative time (minutes) which will be defined as the time from incision to closure. |
| Intraoperative and postoperative complications | At 1, 6, and 12 months | Rate of intraoperative and postoperative complications, according to the Clavien-Dindo classification |
| Blood loss | During the intervention | Volume of blood loss (mL) |
| Pain symptoms | At 30 days, and at 3, 6, and 12 months postoperatively. | Mean numeric rating scale (NRS) from 0 to 10 where 10 is extreme pain. |
| Length of hospital stay | From the intervanetion day to the day of discharge from hospital (within 30 days after surgery) | Total number of days in the hospital |
| Hospital readmissions | 30 days after surgery | Rate of hospital readmissions |
| Reoperation | Within 30 days after surgery | Rate of reoperation |
| Robotic and complex laparoscopic expertise of the surgeons | 1 year | Number of robotic and complex laparoscopic procedures performed by the surgeons involved and in the hospitals involved |
| Endometriosis Health Profile-30 (EHP30) | At baseline and at 3, 6, and 12 month. | Patients' quality of life COmpletion of hte Endometriosis-related quality of life |
| Completion of Questionnaires Borg CR-10 Scale | Day 0 (surgery) | Perceived exertion by surgeons of laparoscopic and robotic intervention. |
Countries
France
Contacts
CONTACTPierre MD COLLINET
Outcome results
None listed