ENDOmetriosis Robotic Assisted Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Total 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
• Устройство Ureterolysis
  unilateral or bilateral ureterolysis with or without bilateral adnexectomy

Первичные конечные точки

• Intra and post-operative complication rates [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Short Form Health Survey (SF-36) [Срок оценки: At baseline and at 3, 6, and 12 month.]
• Patients' sexual quality of life [Срок оценки: At baseline and at 3, 6, and 12 months.]
• Duration of the intervention [Срок оценки: Time from incision to closure (12 months)]
• Intraoperative and postoperative complications [Срок оценки: At 1, 6, and 12 months]
• Blood loss [Срок оценки: During the intervention]
• Pain symptoms [Срок оценки: At 30 days, and at 3, 6, and 12 months postoperatively.]
• Length of hospital stay [Срок оценки: From the intervanetion day to the day of discharge from hospital (within 30 days after surgery)]
• Hospital readmissions [Срок оценки: 30 days after surgery]
• Reoperation [Срок оценки: Within 30 days after surgery]
• Robotic and complex laparoscopic expertise of the surgeons [Срок оценки: 1 year]
• Completion of Questionnaires Borg CR-10 Scale [Срок оценки: Day 0 (surgery)]
• Endometriosis Health Profile-30 (EHP30) [Срок оценки: At baseline and at 3, 6, and 12 month.]

Критерии участия

Критерии включения

• ≥ 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.

Критерии исключения

• Digestive tract involvement.
• Adenomyosis only.
• Contraindications to surgery.
• Participants who are under guardianship, curatorship, or deprivation of liberty.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Hôpital Privé de Provence — Aix-en-Provence
• Hôpital Privé le Bois — Lille

Публикации

• Renso M, Bendifallah S, Estrade JP, Merlot B, Roman H, Vidal F, Collinet P. Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e108125. doi: 10.1136/bmjopen-2025-108125. PMID 41314847

Идентификаторы

NCT: NCT06445179 · 2024-A00350-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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