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

Azienda Sanitaria-Universitaria Integrata di Udine

Status: Not yet enrolling

Conditions: Ovarian Diseases

Treatments: Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06750003

33935

Details and patient eligibility

About

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

Full 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

Enrollment: 22 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

3D laparoscopy

Active Comparator group

Description:

Performed using 3D laparoscopy

Treatment:

Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy

4K laparoscopy

Experimental group

Description:

Performed using 4K laparoscopy

Treatment:

Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy