Ovarian DiseasesTOLSTOYNCT06750003
4K Versus 3D Total Laparoscopic Bilateral Oophorectomy: Tools in Comparison
A study testing 3D versus 4K laparoscopic bilateral salpingo-oophorectomy in people with Ovarian Diseases, run by Azienda Sanitaria-Universitaria Integrata di Udine.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Diseases
- What is being tested?
- 3D versus 4K laparoscopic bilateral salpingo-oophorectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suspected neoplastic pathology
- Patients not eligible for surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: 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
Read the 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
- Conditions
- Ovarian Diseases
- Being tested
- 3D versus 4K laparoscopic bilateral salpingo-oophorectomy
- Keywords
- Benign ovarian disease, laparoscopy, annessiectomy, ovariectomy, resident, tridimensional, high definition surgery, 3D, 4K
- Medical subject headings
- Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D versus 4K laparoscopic bilateral salpingo-oophorectomyProcedure or surgery
3D laparoscopy versus 4K laparoscopy for bilateral salpingo-oophorectomy performed by residents
| Study group | Role | What they receive |
|---|---|---|
| 3D laparoscopy | Active comparator | Performed using 3D laparoscopy Receives: Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy |
| 4K laparoscopy | Experimental | Performed using 4K laparoscopy Receives: Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
To compare the operative time of bilateral oophorectomy performed using 3D laparoscopy versus 4K laparoscopy for benign indications, conducted by trainee surgeons.
Measured: from enrollment to the end of follow up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Restaino, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750003
- Sponsor's protocol ID
- 33935
- Acronym
- TOLSTOY
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison
- ClinicalTrials.gov ID
- NCT06750003
- Acronym / sponsor ID
- TOLSTOY / 33935
- Conditions
- Ovarian Diseases
- Keywords
- Benign ovarian disease, laparoscopy, annessiectomy, ovariectomy, resident, tridimensional, high definition surgery, 3D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D laparoscopy | Active comparator | Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomyPerformed using 3D laparoscopy |
| 4K laparoscopy | Experimental | Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomyPerformed using 4K laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Suspected neoplastic pathology
- Patients not eligible for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D versus 4K laparoscopic bilateral salpingo-oophorectomy3D laparoscopy versus 4K laparoscopy for bilateral salpingo-oophorectomy performed by residents | Procedure or surgery | 3D laparoscopy, 4K laparoscopy |
Primary outcome
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.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D versus 4K laparoscopic bilateral salpingo-oophorectomy in people with Ovarian Diseases, run by Azienda Sanitaria-Universitaria Integrata di Udine.
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 5 inclusion and 2 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 MD, Graduation (0432 559695, stefano.restaino@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: from enrollment to the end of follow up at 12 months). 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 27 Dec 2024.