Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06278636 |
Other study ID # |
5745 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 18, 2023 |
Est. completion date |
January 30, 2025 |
Study information
Verified date |
June 2023 |
Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact |
Floriana Mascilini |
Phone |
0630156399 |
Email |
floriana.mascilini[@]policlinicogemellli.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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