Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Deep Endometriosis. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared
Overview
The aim is to clarify whether both surgical approaches represent, equivalently, a good treatment for the management of patients with deep endometriosis who are candidates for surgery, or whether there are any differences between the two methods, and, if so, how they differ
Detailed description
Numerous studies have shown how surgical excision of deep endometriosis nodules improves pain and quality of life. Robotic-assisted laparoscopic surgery has been employed for the treatment of deep endometriosis. While the Da Vinci System is widely used for the surgical treatment of endometriosis, with good results, the available data regarding the benefits of the HUGO RAS System, however, are limited, given the recent introduction of this method in gynecology, and particularly in the treatment of endometriosis. The aim of the study is to investigate whether the robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis
Primary outcome measures
- The robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis [Time frame: During surgery]
Secondary outcome measures (8)
- Conversion rate to laparoscopy or laparotomy [Time frame: During surgery]
- Intra-operative and post-operative complication rates; need for complication treatment [Time frame: Perioperative and at 3 months]
- Ergonomics for the surgeon [Time frame: During surgery]
- Entity of postoperative pain [Time frame: Perioperative and at 3 and 12 months]
- Hospitalization time [Time frame: From the day of admission to the day of discharge, an average of 1 year]
- Assessment of pain and quality of life [Time frame: At 3 and 12 months after surgery]
- Assessment of pain and quality of life [Time frame: At 3 and 12 months after surgery]
- Symptomatological and/or anatomical recurrence [Time frame: At 12 months after surgery]
Eligibility criteria
Inclusion criteria
- Age between 18 and 55 years;
- Pelvic ultrasound and/or radiologic (MRI/CT scan with rectal insufflation) diagnosis of endometriosis
- Indication for surgery (symptomatic despite or refractory to medical therapy, and/or with critical bowel stenosis or urinary stenosis, and/or infertile awaiting medically assisted procreation (PMA) treatment or with previous failed assisted fertilization attempts);
- ASA (American Society of Anesthesiologists physical status classification) class between 1 and 3;
- Acquisition of consent to undergo surgical treatment;
- Acquisition of consent for study participation and data processing
Exclusion criteria
\- Past or current diagnosis of gynecologic oncologic pathology.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
- Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuor — Roma
Identifiers
NCT: NCT06781398 · ROBOTENDO