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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06750003
Acronym
TOLSTOY
Enrollment
22
Registered
2024-12-27
Start date
2024-12-15
Completion date
2026-12-31
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Diseases

Keywords

Benign ovarian disease, laparoscopy, annessiectomy, ovariectomy, resident, tridimensional, high definition surgery, 3D, 4K

Brief summary

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

Detailed description

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

Interventions

PROCEDURE3D versus 4K laparoscopic bilateral salpingo-oophorectomy

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

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
operative timefrom enrollment to the end of follow up at 12 monthsTo compare the operative time of bilateral oophorectomy performed using 3D laparoscopy versus 4K laparoscopy for benign indications, conducted by trainee surgeons.

Contacts

Primary ContactMD, Graduation
stefano.restaino@asufc.sanita.fvg.it0432 559695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026