Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06781398

Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Conversion rate to laparoscopy or laparotomy

    Time frame: During surgery

    Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture

  2. Intra-operative and post-operative complication rates; need for complication treatment

    Time frame: Perioperative and at 3 months

    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)

  3. Ergonomics for the surgeon

    Time frame: During surgery

    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)

  4. Entity of postoperative pain

    Time frame: Perioperative and at 3 and 12 months

    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

  5. Hospitalization time

    Time frame: From the day of admission to the day of discharge, an average of 1 year

    Hospitalization time

  6. Assessment of pain and quality of life

    Time frame: At 3 and 12 months after surgery

    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

  7. Assessment of pain and quality of life

    Time frame: At 3 and 12 months after surgery

    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

  8. Symptomatological and/or anatomical recurrence

    Time frame: At 12 months after surgery

    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)

Study contacts

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

Diego Raimondo, MD

CONTACT

[email protected]

+393290636618

Pierluigi Celerino, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

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.