Deep EndometriosisNCT06781398
Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison
An observational study of Deep Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Deep Endometriosis
- How many people
- 86 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who are candidates for surgery with minimally invasive approach for endometriosis
Who may be able to join
- 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
Who cannot join
- Past or current diagnosis of gynecologic oncologic pathology.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pierluigi Celerino, MD contact
Italy2 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com
Pierluigi Celerino, MD, celerinopierluigi@gmail.com
Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
Roma, Roma, 00168
Federica Campolo, MD, +390630155629, campolo.f@gmail.com
About this study
Official title: Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared
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
Read the 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
- Conditions
- Deep Endometriosis
- Keywords
- endometriosis, gynaecology, surgery, Da Vinci, HUGO RAS
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Compare the two surgical techniques by evaluating the operative time (expressed in minutes), which includes docking and surgical time.
Docking is defined as the time required to move the robotic arms into the operative field, place them in their respective port sites, and insert the robotic instruments into the abdomen.
Surgical time is from the end of docking to suturing the laparoscopic/laparotomy breaches.
Measured: During surgery
Secondary outcomes (8)
Conversion rate to laparoscopy or laparotomy
Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture
Measured: During surgery
Intra-operative and post-operative complication rates; need for complication treatment
Intraoperative complications (incidental injury to organs and structures, incoercible bleeding) classified by ClassIntra System (iAE); postoperative complications (anemia, postoperative fever, hemoperitoneum, bowel perforation), according to Clavien-Dindo classification; treatment of complications (GRC transfusion, reintervention, interventional procedures)
Measured: Perioperative and at 3 months
Ergonomics for the surgeon
Ergonomics of the two robotic approaches established through the Rapid Upper Limb Assessment (RULA) system that allows through the compilation of a score, rapid assessment of the load on the neck and upper limb. The risk of work-related disorders is calculated in a score from 1 (low) to 7 (high)
Measured: During surgery
Entity of postoperative pain
Postoperative pain assessed as maximum value recorded by numeric rating scale (NRS), from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable' respectively
Measured: Perioperative and at 3 and 12 months
Hospitalization time
Hospitalization time
Measured: From the day of admission to the day of discharge, an average of 1 year
Assessment of pain and quality of life
Pain assessment and change in quality of life, assessed by administration of NRS scale, from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable' respectively
Measured: At 3 and 12 months after surgery
Assessment of pain and quality of life
Pain assessment and change in quality of life, assessed by administration of quality of life questionnaire (EHP-30, Endometriosis-related health profile), scored from 0 to 100, with 0 being the best outcome and 100 the worst outcome
Measured: At 3 and 12 months after surgery
Symptomatological and/or anatomical recurrence
Clinical or anatomical resumption of disease by gynecological examination, recent pathological history, pelvic ultrasound, and possible radiological methods such as nuclear magnetic resonance imaging (NMR)
Measured: At 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Raimondo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781398
- Sponsor's protocol ID
- ROBOTENDO
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared
- ClinicalTrials.gov ID
- NCT06781398
- Acronym / sponsor ID
- ROBOTENDO
- Conditions
- Deep Endometriosis
- Keywords
- endometriosis, gynaecology, surgery, Da Vinci, HUGO RAS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who are candidates for surgery with minimally invasive approach for endometriosis
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Past or current diagnosis of gynecologic oncologic pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Compare the two surgical techniques by evaluating the operative time (expressed in minutes), which includes docking and surgical time. Docking is defined as the time required to move the robotic arms into the operative field, place them in their respective port sites, and insert the robotic instruments into the abdomen. Surgical time is from the end of docking to suturing the laparoscopic/laparotomy breaches.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierluigi Celerino, MD contact
Diego Raimondo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Raimondo, MD (+393290636618, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.