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OpenTrials
Completed

NCT Number: NCT06138197

Comparison of Three Robotic Platforms for Hysterectomy

Hysterectomy is the most common procedure in gynaecology after a cesarean section. In recent years, the laparoscopic approach has become preferred given the different advantages over the traditional laparotomic approach, and both conventional laparoscopy and robotic-assisted laparoscopy have become the standard approach for hysterectomy. To date, robotic-assisted laparoscopic hysterectomy has been performed using one robotic platform and only recently, two new robotic platforms have been introduced in clinical practice. Although all three are registered for human use and available for clinical practice, there are currently not enough clinical experiences and data in the literature to evaluate the efficacy, safety and relationship between cost and efficacy of the new platforms available for the robotic-assisted laparoscopic hysterectomy. For this reason, the investigators will conduct an exploratory clinical study on a Post Market Clinical Follow up (PMCF) medical device aimed at performing a preliminary assessment of the global performance of the ITL procedure implemented using the three robotic platforms currently available.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, 37125, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing elective total laparoscopic hysterectomy surgery
  • Age > 18 years
  • Signature of the informed consent

Exclusion criteria

  • Patients undergoing emergency surgery
  • Patients who are candidates for hysterectomy for a non-gynaecological indication
  • Patients undergoing previous radiation therapy
  • Patients unable to express adequate informed consent to participate in the study

Treatment and study plan

Robotic-assisted hysterectomy

Procedure

Robotic-assisted hysterectomy following usual surgical technique

Primary outcomes

  1. Textbook outcome satisfaction

    Time frame: 90 days after surgery

    Robotic-assisted hysterectomy performed without laparotomy conversion, intraoperative complications, postoperative complications (Clavien-Dindo classification ≥2), the performance of postoperative imaging excluding transvaginal ultrasound, reoperation, length of stay after day of surgery >2 days, readmission within 90 days, mortality, surgery length greater than 120 minutes, or intraoperative blood loss greater than 100mL. The Textbook outcome will be considered fulfilled if all conditions are met.

Secondary outcomes

  1. Intraoperative complications

    Time frame: During surgery

    Intraoperative complications graded based on the Clavien-Dindo classification

  2. Postoperative complications

    Time frame: 30 and 90 days after surgery

    Postoperative complications graded based on the Clavien-Dindo classification

  3. Operative time

    Time frame: During surgery

    Time between first incision and skin closure

  4. Intraoperative blood loss

    Time frame: During surgery

    Total blood aspirate during the surgical procedure

  5. Sexual function

    Time frame: 90 and 180 days after surgery

    The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function.

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow Up Study

Acronym: COMPAR-HYST

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Mar 4, 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.

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