Gynecologic CancerLUXANCT06278636
Laparoscopic Ultrasound Examination: Analysis of Feasibility
An observational study of Gynecologic Cancer and Surgical Procedure, Unspecified, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Surgical Procedure, Unspecified
- What is being tested?
- Laparoscopi ultrasound examination
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2023to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Eligible population includes 5 fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology (11) and 150 women satisfying inclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rome, 00168
Floriana Mascilini, Dr
Antonia Carla Testa, Prof
About this study
Official title: 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.
Read the 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
- Being tested
- Laparoscopi ultrasound examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopi ultrasound examinationDiagnostic test
Analysis of feasibility and fellow surgeons learning curve in minimally invasive gynecological procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 minutes
Secondary outcomes (2)
the learning curve of fellow surgeons
To investigate the learning curve of fellow surgeons in obtaining skill competency by using laparoscopic probe
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start18 Jul 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mascilini Floriana, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278636
- Sponsor's protocol ID
- 5745
- Acronym
- LUXA
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ultrasound Examination: Analysis of Feasibility and fEllows Surgeons' LEarning Curve in Minimally Invasive Gynecological Procedures
- ClinicalTrials.gov ID
- NCT06278636
- Acronym / sponsor ID
- LUXA / 5745
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible population includes 5 fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology (11) and 150 women satisfying inclusion criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopi ultrasound examinationAnalysis of feasibility and fellow surgeons learning curve in minimally invasive gynecological procedures | Diagnostic test | – |
Primary outcome
feasibility of the laparoscopic
Time frame: 2 minutes
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 secondary outcomes
the learning curve of fellow surgeons
Time frame: 5 minutes
the performance of fellow surgeons
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Surgical Procedure, Unspecified, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floriana Mascilini (0630156399, floriana.mascilini@policlinicogemellli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of the laparoscopic (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.