Prostate CancerONSD-RALPNCT07491198
Effect Of Trendelenburg Position And Pneumoperitoneum On Optic Nerve Sheath Diameter In Robot-Assisted Prostatectomy
An observational study of Prostate Cancer and Optic Nerve Sheath Diameter, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Optic Nerve Sheath Diameter, Robot-Assisted Radical Prostatectomy
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- ASA physical status I-III
- Patients scheduled for robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia
- Written informed consent obtained
Who cannot join
- History of intracranial surgery or intracranial lesion
- Known ocular disease (glaucoma, retinal detachment, diabetic retinopathy, previous ocular surgery, etc.)
- Intraocular pressure greater than 30 mmHg
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Faculty of Medicine Hospital
Izmir, İzmir, 35100
Nursen Karaca, MD, +902323902142 ext. 2142, dr.nursenkaraca@hotmail.com
Işık Alper, Professor of Anesthesiology, +902323902140 ext. 2140, i.alper@yahoo.com
About this study
Official title: Effect of Steep Trendelenburg Position and Pneumoperitoneum on Optic Nerve Sheath Diameter in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Study
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Optic Nerve Sheath Diameter, Robot-Assisted Radical Prostatectomy, Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
- Keywords
- Optic Nerve Sheath Diameter, Trendelenburg Position, Pneumoperitoneum, Robot-Assisted Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Radical Prostatectomy | Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia. | |
| Open Radical Prostatectomy | Patients undergoing open radical prostatectomy under general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diameter
Measurement of optic nerve sheath diameter using ocular ultrasonography during surgery.
Measured: During surgery at predefined intraoperative time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start5 Jan 2026
- Primary completion1 Oct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursen Karaca, Ege University
- Investigators
- NURSEN KARACA, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491198
- Sponsor's protocol ID
- 25-12.1T/18
- Other IDs
- 25-12.1T/18
- Acronym
- ONSD-RALP
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and institutional restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steep Trendelenburg Position and Pneumoperitoneum on Optic Nerve Sheath Diameter in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT07491198
- Acronym / sponsor ID
- ONSD-RALP / 25-12.1T/18
- Conditions
- Prostate Cancer, Optic Nerve Sheath Diameter, Robot-Assisted Radical Prostatectomy, Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
- Keywords
- Optic Nerve Sheath Diameter, Trendelenburg Position, Pneumoperitoneum, Robot-Assisted Radical Prostatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Radical Prostatectomy | – | –Patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia. |
| Open Radical Prostatectomy | – | –Patients undergoing open radical prostatectomy under general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- ASA physical status I-III
- Patients scheduled for robot-assisted laparoscopic radical prostatectomy or open radical prostatectomy under general anesthesia
- Written informed consent obtained
Key exclusion criteria (4 listed)
- History of intracranial surgery or intracranial lesion
- Known ocular disease (glaucoma, retinal detachment, diabetic retinopathy, previous ocular surgery, etc.)
- Intraocular pressure greater than 30 mmHg
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optic Nerve Sheath Diameter
Time frame: During surgery at predefined intraoperative time points
Measurement of optic nerve sheath diameter using ocular ultrasonography during surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and institutional restrictions.
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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.
NURSEN KARACA, MD principal investigator
Ege University
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 Prostate Cancer and Optic Nerve Sheath Diameter, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nursen Karaca, MD (+902323902142 ext. 2142, dr.nursenkaraca@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic Nerve Sheath Diameter (time frame: During surgery at predefined intraoperative time points). 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 10 Sep 2026.