CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05668208
NCT05668208N/ACompleted

Comparison of the Effects of Extraperitoneal and Transperitoneal Laparoscopic Surgeries on Intracranial Pressure: A Prospective Clinical Study

Konya City Hospital·interventional·Posted Dec 29, 2022·Updated Mar 14, 2023

In Brief

A clinical study evaluating E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea) for Intracranial Pressure Increase. Completed, enrolled 60 participants across 1 site.

Detailed Summary

When the literature is examined, it has been reported in many studies that intracranial pressure increases due to laparoscopic procedures performed in the intraperitoneal area. The mechanism of increased intracranial pressure (ICP) associated with insufflation is most likely due to impaired venous drainage of the lumbar venous plexus at increased intra-abdominal pressure. Changes in ICP can be monitored by ultrasonographic measurement of optic nerve sheath diameter (ONSD), which is a generally accepted simple, reliable and non-invasive ICP measurement technique. In meta-analyses conducted on this subject, it has been revealed that ICP elevation during laparoscopy can be observed with a significant increase in ONSD in the early (0 30 minutes) and late (30-120 minutes) periods during carbondioxid (CO2) pneumoperitoneum. However, the effect of laparoscopic procedures performed in the extraperitoneal area on the central nervous system is not clear. There is not found any study in the literature comparing laparoscopic procedures, especially performed extraperitoneally and transperitoneally, and their effects on intracranial pressure. The aim of the study compare to laparoscopic cholecystectomy performed in the transperitoneal area and (totally extra-peritoneal) TEP inguinal hernia repair performed in the extraperitoneal area in terms of intracranial pressure relationship.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedDec 29, 2022
Enrollment StartJan 6, 2023
Primary CompletionJan 15, 2023
Study CompletionJan 20, 2023
TodayJul 2, 2026
Enrollment to primary: 9 daysPosted 3.5 years ago

Interventions

E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)device

ONSD measurement will be made using the E-CUBE i7 ultrasound system.