NCT06750003

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Dec 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

December 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 15, 2024

Last Update Submit

December 19, 2024

Conditions

Ovarian Diseases

Keywords

Benign ovarian diseaselaparoscopyannessiectomyovariectomyresidenttridimensionalhigh definition surgery3D4K

Outcome Measures

Primary Outcomes (1)

  • operative time

    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

Study Arms (2)

3D laparoscopy

ACTIVE COMPARATOR

Performed using 3D laparoscopy

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

4K laparoscopy

EXPERIMENTAL

Performed using 4K laparoscopy

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

Interventions

3D versus 4K laparoscopic bilateral salpingo-oophorectomyPROCEDURE

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

3D laparoscopy4K laparoscopy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Suspected neoplastic pathology
  • Patients not eligible for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Diseases

Condition Hierarchy (Ancestors)

Adnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

MD, Graduation

CONTACT

0432 559695stefano.restaino@asufc.sanita.fvg.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 15, 2024

First Posted

December 27, 2024

Study Start

December 15, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share