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Not yet recruiting NCT06750003

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

No phase Interventional Ovarian Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy.
Who it may be relevant to
Registry conditions: Ovarian Diseases. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • operative time [Time frame: from enrollment to the end of follow up at 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06750003 · 33935

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗