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

December 19, 2024 updated by: Stefano Restaino, Azienda Sanitaria-Universitaria Integrata di Udine

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3D laparoscopy
Performed using 3D laparoscopy
Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy
3D laparoscopy versus 4K laparoscopy for bilateral salpingo-oophorectomy performed by residents
Experimental: 4K laparoscopy
Performed using 4K laparoscopy
Procedure: 3D versus 4K laparoscopic bilateral salpingo-oophorectomy
3D laparoscopy versus 4K laparoscopy for bilateral salpingo-oophorectomy performed by residents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment to the end of follow up at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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