Laparoscopic Ultrasound Examination: Analysis of Feasibility (LUXA)

Laparoscopic Ultrasound Examination: Analysis of Feasibility and fEllows Surgeons' LEarning Curve in Minimally Invasive Gynecological Procedures

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Surgical Procedure, Unspecified
• Intervention / Treatment: Diagnostic test: Laparoscopi ultrasound examination

Detailed Description

The use of laparoscopic ultrasound is an evolving field with a potentially wide range of advantages that could facilitate complex gynecologic surgical procedures; increasing surgical safety by allowing the surgeon to see beyond the surface of the organ, visualizing anatomical structures and identifying, for example, retroperitoneal recurrences and benign or malignant pelvic lesions, even small and not visible laparoscopically, and consequently improving the surgical accuracy of tumor resection. (10) Gynecologists who are familiar with gynecological transvaginal ultrasound should be able to become proficient in identifying pelvic organs during surgical procedures in order to improve surgical accuracy, reduce complications, and ultimately improve patient care.

Nevertheless, this technique has been slow to be implemented in the clinical setting, perhaps due to the lack of a learning curve. Therefore, training gynecological surgical fellows in recognizing pelvic structures using laparoscopic probes is critical for allows them to use this tool in different application fields, providing them with an important advantage. The training of gynecological surgeons in the use of laparoscopic probes would provide an advantage in terms of surgical time, speeding up the procedures of recognition and removal of target lesions. In addition, by making surgeons autonomous in the operating theatre, the need for an additional ultrasound operator during surgery would be eliminated. These benefits would translate into a potential reduction in cost as well

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Floriana Mascilini; Phone Number: 0630156399; Email: floriana.mascilini@policlinicogemellli.it
• Study Contact Backup: Name: Maria Teresa Giudice; Phone Number: 0630156399; Email: mariateresa.giulia@guest.policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
    • Contact: Floriana Mascilini, Dr
    • Contact: Antonia Carla Testa, Prof
    • Principal Investigator: Floriana Mascilini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the learning curve of fellow surgeons	To investigate the learning curve of fellow surgeons in obtaining skill competency by using laparoscopic probe	5 minutes
the performance of fellow surgeons	To evaluate the performance of fellow surgeons in obtaining high-quality US images of anatomical parameters using expert assessment as the gold standard and in achieving a reduction in the operative time of laparoscopic probe use.	30 minutes

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 5745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Laparoscopic Ultrasound examination: analysis of Feasibility and fEllows Surgeons' LEarning Curve in minimally invasive gynecological procedures
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No