4K Versus 3D Total Laparoscopic Bilateral Oophorectomy by Surgeons in Training: Tools in Comparison
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 22
- Primary Endpoint
- operative time
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
3D laparoscopy
Performed using 3D laparoscopy
Intervention: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy (Procedure)
4K laparoscopy
Performed using 4K laparoscopy
Intervention: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy (Procedure)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Stefano Restaino
Doctor
Azienda Sanitaria-Universitaria Integrata di Udine