A new clinical trial is set to investigate the role of optic nerve sheath diameter (ONSD) measurements as a potential indicator of intracranial pressure (ICP) in two widely used gynecological surgical methods: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and total laparoscopic hysterectomy (TLH). This trial will help clinicians and regulators better understand the physiological impact of these minimally invasive surgical procedures.
ClinicalTrials.gov recently listed this trial under the sponsorship of Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, with a targeted participant pool focused on conditions like endometrial cancer, abnormal uterine bleeding, myoma, or uterine pathology. As of late November 2025, recruitment has yet to begin.
In this article:
- What is the study about?
- How is ONSD connected to ICP monitoring?
- Who will participate in this trial?
What is the study about?
This investigation seeks to compare the impact of two minimally invasive surgical methods, vNOTES and TLH, on changes in intracranial pressure. Intracranial pressure can be indirectly measured through optic nerve sheath diameter, which responds sensitively to shifts in cerebrospinal fluid dynamics during surgical procedures. This makes ONSD a non-invasive and real-time indicator that may enhance safety monitoring during surgeries.
The trial addresses an ongoing need among clinicians to evaluate how different surgical techniques influence systemic and neurological parameters. By studying ICP fluctuations, the aim is to supplement surgical decision-making protocols, leading to optimized patient safety and outcomes.
How is ONSD connected to ICP monitoring?
ONSD measurement is increasingly regarded as a reliable method to estimate ICP. During conditions of elevated intracranial pressure, the optic nerve becomes compressed, causing measurable widening of its sheath. This response provides a practical marker where direct invasive monitoring is not feasible.
This study integrates this technique in the context of gynecological procedures, marking a novel application of the method. By measuring ONSD before, during, and after surgeries, researchers aim to map any ICP variations induced by the surgical approach and identify if one procedure carries lower risks of associated complications.
Who will participate in this trial?
The clinical trial aims to recruit patients experiencing conditions such as endometrial cancer, abnormal uterine bleeding, uterine myomas, or other uterine pathologies, all of which may necessitate minimally invasive surgical intervention. These conditions align with the inclusion criteria for vNOTES and TLH, offering a representative sample for finding reliable data on ICP changes.
This patient-centered approach will help ensure the results are directly applicable to real-world scenarios faced by gynecological surgeons and anesthesiologists.
FAQ
- Why study ONSD in gynecological surgery?
ONSD provides a non-invasive way to track changes in intracranial pressure, potentially improving safety monitoring during surgeries. - What makes vNOTES and TLH different?
Both are minimally invasive procedures, but they differ in surgical approach and physiological implications, which will be examined in this study. - Who is funding the study?
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the listed sponsor.
Conclusion
This clinical trial represents an exciting step in combining non-invasive diagnostic methods with minimally invasive surgical innovations. For regulators, clinicians, and health systems, the results could inform best practices in patient monitoring and safety during gynecological procedures. Stakeholders should monitor this study’s updates to incorporate any resulting recommendations into practice.
Disclaimer
This content is intended for informational purposes only and should not be considered as legal or medical advice. Always consult professional guidelines and governing policies for decision-making.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07250178?term=medical+device