Clinical trial · Observational
Laparoscopic Ultrasound Examination: Analysis of Feasibility
Laparoscopic Ultrasound Examination: Analysis of Feasibility and fEllows Surgeons' LEarning Curve in Minimally Invasive Gynecological Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopi ultrasound examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- feasibility of the laparoscopic
- timeFrame
- 2 minutes
- description
- 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
Secondary outcomes (2)
- measure
- the learning curve of fellow surgeons
- timeFrame
- 5 minutes
- description
- To investigate the learning curve of fellow surgeons in obtaining skill competency by using laparoscopic probe
- measure
- the performance of fellow surgeons
- timeFrame
- 30 minutes
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available