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

Not Applicable

Not yet recruiting

• Conditions: Ovarian Diseases

• Registration Number: NCT06750003
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-15
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
operative time	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.