Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06445179

ENDOmetriosis Robotic Assisted Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé de Provence, Aix-en-Provence, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total laparoscopic hysterectomy

Procedure

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.

Ureterolysis

Device

unilateral or bilateral ureterolysis with or without bilateral adnexectomy

Primary outcomes

  1. Intra and post-operative complication rates

    Time frame: 3 months

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

Secondary outcomes

  1. Short Form Health Survey (SF-36)

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

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

  2. Patients' sexual quality of life

    Time frame: 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.

  3. Duration of the intervention

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

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

  4. Intraoperative and postoperative complications

    Time frame: At 1, 6, and 12 months

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

  5. Blood loss

    Time frame: During the intervention

    Volume of blood loss (mL)

  6. Pain symptoms

    Time frame: 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.

  7. Length of hospital stay

    Time frame: From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)

    Total number of days in the hospital

  8. Hospital readmissions

    Time frame: 30 days after surgery

    Rate of hospital readmissions

  9. Reoperation

    Time frame: Within 30 days after surgery

    Rate of reoperation

  10. Robotic and complex laparoscopic expertise of the surgeons

    Time frame: 1 year

    Number of robotic and complex laparoscopic procedures performed by the surgeons involved and in the hospitals involved

  11. Completion of Questionnaires Borg CR-10 Scale

    Time frame: Day 0 (surgery)

    Perceived exertion by surgeons of laparoscopic and robotic intervention.

  12. Endometriosis Health Profile-30 (EHP30)

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

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

  13. Completion of Questionnaires NASA-TLX

    Time frame: Day 0 (surgery)

    Perceived exertion by surgeons of laparoscopic and robotic intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre MD COLLINET

CONTACT

[email protected]

677707402 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial

Acronym: ENDO-RAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.