Menu
Recruiting NCT07491198

Effect Of Trendelenburg Position And Pneumoperitoneum On Optic Nerve Sheath Diameter In Robot-Assisted Prostatectomy

Observational Prostate Cancer Optic Nerve Sheath Diameter Robot-Assisted Radical Prostatectomy Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostate Cancer, Optic Nerve Sheath Diameter, Robot-Assisted Radical Prostatectomy, Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Steep Trendelenburg Position and Pneumoperitoneum on Optic Nerve Sheath Diameter in Robot-Assisted Laparoscopic Radical Prostatectomy: A Prospective Study

Overview

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.

Primary outcome measures

  • Optic Nerve Sheath Diameter [Time frame: During surgery at predefined intraoperative time points]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ege University Faculty of Medicine Hospital — Izmir

Identifiers

NCT: NCT07491198 · 25-12.1T/18 · 25-12.1T/18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗