4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison

Evaluate whether the 4K laparoscopic vision system can provide an advantage in performing bilateral oophorectomy procedures for benign conditions carried out by trainee surgeons compared to 3D laparoscopy

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Key information

Conditions

Ovarian Diseases Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

All patients diagnosed with suspected benign ovarian pathology based on preoperative examinations (pelvic Doppler ultrasound and/or magnetic resonance imaging and/or CT scan) and with indication for bilateral laparoscopic adnexectomy will be enrolled in the study. The primary objective of the study is to compare surgical times between the 3D and 4K vision systems in laparoscopic ovarian surgery, specifically in bilateral adnexectomy performed by trainee surgeons. Secondary objectives will include evaluating intra- and postoperative complications, length of hospital stay, and costs to the healthcare system

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with benign ovarian pathology requiring bilateral oophorectomy
ASA score <3
Patients who have signed the appropriate informed consent
Patients who are not pregnant or diagnosed with pelvic inflammatory disease
No history of prior major abdominal surgery

Exclusion criteria

Suspected neoplastic pathology
Patients not eligible for surgery

Treatment and study plan

3D versus 4K laparoscopic bilateral salpingo-oophorectomy

Procedure

3D laparoscopy versus 4K laparoscopy for bilateral salpingo-oophorectomy performed by residents

Primary outcomes

operative time

Time frame: from enrollment to the end of follow up at 12 months

To compare the operative time of bilateral oophorectomy performed using 3D laparoscopy versus 4K laparoscopy for benign indications, conducted by trainee surgeons.

Study contacts

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

MD, Graduation

CONTACT

[email protected]

0432 559695

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison

Acronym: TOLSTOY

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Dec 27, 2024
Registry last updated: Dec 27, 2024

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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