Assessing the feasibility of laparoscopic ultrasound during gynecological surgery
Laparoscopic Ultrasound Examination: Analysis of Feasibility and fEllows Surgeons' LEarning Curve in Minimally Invasive Gynecological Procedures
This study is testing whether using laparoscopic ultrasound during gynecological surgeries can help surgeons perform better and improve patient care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06278636 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study evaluates the feasibility of using laparoscopic ultrasound examination directly by surgeons during minimally invasive gynecological surgeries. It aims to assess the learning curve for surgical fellows and the quality of ultrasound images obtained. The study will also analyze patients' medical histories and symptoms to determine their impact on the procedure's success. By integrating laparoscopic ultrasound into surgical practice, the study seeks to enhance surgical accuracy and efficiency, ultimately improving patient care.
Who should consider this trial
Good fit: Ideal candidates include women with gynecological conditions requiring elective laparoscopic surgery, such as early-stage cervical cancer or endometrial cancer.
Not a fit: Patients undergoing emergency surgeries or those with previous hysterectomies or salpingo-oophorectomies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and reduce complications for patients undergoing gynecological procedures.
How similar studies have performed: While the use of laparoscopic ultrasound is an evolving field, this specific approach to training surgeons and integrating the technique into surgical practice is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Floriana Mascilini
- Email: floriana.mascilini@policlinicogemellli.it
- Phone: 0630156399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.