An observational study in Prostate Cancer, Optic Nerve Sheath Diameter and Robot-Assisted Radical Prostatectomy, sponsored by Ege University. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Ege University · Observational
This prospective study aims to evaluate the effect of steep Trendelenburg position and pneumoperitoneum on optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic radical prostatectomy and open radical prostatectomy under general anesthesia. Increased intracranial pressure may occur during robotic surgery due to pneumoperitoneum and head-down positioning. Optic nerve sheath diameter measured by ocular ultrasonography is a non-invasive method used to assess intracranial pressure changes. Hemodynamic and respiratory parameters will also be recorded during surgery. The results of this study may help to better understand the physiological effects of surgical position and pneumoperitoneum during prostatectomy procedures.
Robot-assisted laparoscopic radical prostatectomy requires steep Trendelenburg positioning and carbon dioxide pneumoperitoneum to improve the surgical field. These conditions may lead to increased intracranial pressure due to venous congestion and elevated intrathoracic pressure. Optic nerve sheath diameter measurement by ultrasonography is a noninvasive method that can be used to estimate changes in intracranial pressure during surgery.
In this prospective study, patients undergoing robot-assisted laparoscopic radical prostatectomy will be compared with patients undergoing open radical prostatectomy. Optic nerve sheath diameter will be measured at predefined time points during surgery using ocular ultrasonography. Hemodynamic parameters, respiratory variables, intra-abdominal pressure, duration of surgery, blood loss, and administered fluids will also be recorded.
The aim of this study is to evaluate the effect of pneumoperitoneum and steep Trendelenburg position on optic nerve sheath diameter and to determine the relationship between optic nerve sheath diameter and intraoperative physiological changes.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
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Adult male patients aged 18 years and older with ASA physical status I-III who are scheduled for robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia at Ege University Faculty of Medicine Hospital will be included in this prospective observational study.
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Exclusion Criteria:
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia.
Patients undergoing open radical prostatectomy under general anesthesia.
Optic Nerve Sheath Diameter
Measurement of optic nerve sheath diameter using ocular ultrasonography during surgery.
Time frame: During surgery at predefined intraoperative time points
Plan to share: No — Individual participant data will not be shared due to privacy and institutional restrictions.
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