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

NCT ID: NCT06750003

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Ovarian Diseases

Keywords

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Benign ovarian disease laparoscopy annessiectomy ovariectomy resident tridimensional high definition surgery 3D 4K

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3D laparoscopy

Performed using 3D laparoscopy

Group Type ACTIVE_COMPARATOR

3D versus 4K laparoscopic bilateral salpingo-oophorectomy

Intervention Type PROCEDURE

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

4K laparoscopy

Performed using 4K laparoscopy

Group Type EXPERIMENTAL

3D versus 4K laparoscopic bilateral salpingo-oophorectomy

Intervention Type PROCEDURE

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

Interventions

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3D versus 4K laparoscopic bilateral salpingo-oophorectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

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Stefano Restaino

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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MD, Graduation

Role: CONTACT

Phone: 0432 559695

Email: [email protected]

Other Identifiers

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33935

Identifier Type: -

Identifier Source: org_study_id