Laparoscopic Ultrasound Examination: Analysis of Feasibility

NCT06278636 | Unknown

• 1 other identifier: 5745
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery. The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon.

Conditions

Gynecologic Cancer; Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

• feasibility of the laparoscopic

  for to assess the feasibility of the laparoscopic ultrasound examination during minimally invasive gynaecological surgery, achievement of one ultrasound picture in maximum 120 seconds examination during minimally invasive gynaecological surgery, in terms of achievement of one ultrasound picture in maximum 120 seconds

  2 minutes

Secondary Outcomes (2)

• the learning curve of fellow surgeons

  5 minutes

• the performance of fellow surgeons

  30 minutes

Interventions

Laparoscopi ultrasound examination DIAGNOSTIC_TEST

Analysis of feasibility and fellow surgeons learning curve in minimally invasive gynecological procedures

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible population includes 5 fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology (11) and 150 women satisfying inclusion criteria

You may qualify if:

• Fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology.
• Women affected by gynecological pathologies undergoing elective laparoscopic surgery such as endometrial cancer, cervical cancer at early stage, or benign pathologies.
• All women will be required to sign written informed consent to enter the study.

You may not qualify if:

• Patients affected by gynaecological pathologies undergoing emergency surgeries.
• Refusal to sign written informed consent.
• Patients with previous hysterectomy or salpingo-oophorectomy.
• Uterus and adnexa not visualised at LPS examination.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, 00168, Italy

RECRUITING

Central Study Contacts

Floriana Mascilini

CONTACT

0630156399; floriana.mascilini@policlinicogemellli.it

Maria Teresa Giudice

CONTACT

0630156399; mariateresa.giulia@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: February 26, 2024
• Study Start: July 18, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 26, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Laparoscopic Ultrasound examination: analysis of Feasibility and fEllows Surgeons' LEarning Curve in minimally invasive gynecological procedures

Locations

IT (1)