Laparoscopic Ultrasound Examination: Analysis of Feasibility

NCT ID: NCT06278636

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2025-01-30

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.

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

Conditions

Gynecologic Cancer; Surgical Procedure, Unspecified

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Laparoscopi ultrasound examination

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Mascilini Floriana

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Floriana Mascilini

Role: CONTACT

floriana.mascilini@policlinicogemellli.it

0630156399

Maria Teresa Giudice

Role: CONTACT

mariateresa.giulia@guest.policlinicogemelli.it

0630156399

Facility Contacts

Floriana Mascilini, Dr

Role: primary

Antonia Carla Testa, Prof

Role: backup

Other Identifiers

5745

Identifier Type: -

Identifier Source: org_study_id