ENDOmetriosis Robotic Assisted Surgery

GCS Ramsay Santé pour l'Enseignement et la Recherche224 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Endometriosis

Interventions

Total Laparoscopic HysterectomyPROCEDURE

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.

UreterolysisDEVICE

unilateral or bilateral ureterolysis with or without bilateral adnexectomy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hôpital Privé de Provence

Aix-en-Provence, France

RECRUITING

Hôpital Privé le Bois

Lille, France

RECRUITING

Outcomes

Primary Outcomes

Intra and post-operative complication rates

Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).

Time frame: 3 months

Secondary Outcomes

Short Form Health Survey (SF-36)

Patients' quality of life COmpletion of hte Endometriosis-related quality of life

Time frame: At baseline and at 3, 6, and 12 month.

Patients' sexual quality of life

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.

Time frame: At baseline and at 3, 6, and 12 months.

Duration of the intervention

The mean operative time (minutes) which will be defined as the time from incision to closure.

Time frame: Time from incision to closure (12 months)

Intraoperative and postoperative complications

Rate of intraoperative and postoperative complications, according to the Clavien-Dindo classification

Time frame: At 1, 6, and 12 months

Blood loss

Volume of blood loss (mL)

Time frame: During the intervention

Pain symptoms

Mean numeric rating scale (NRS) from 0 to 10 where 10 is extreme pain.

Time frame: At 30 days, and at 3, 6, and 12 months postoperatively.

Length of hospital stay

Central Contacts

Pierre MD COLLINET

CONTACT

677707402 pierre.collinet@hotmail.fr

Data from ClinicalTrials.gov

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