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Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure? - Trial NCT05668208

Access comprehensive clinical trial information for NCT05668208 through Pure Global AI's free database. This phase not specified trial is sponsored by Konya City Hospital and is currently Completed. The study focuses on Intracranial Pressure Increase. Target enrollment is 60 participants.

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NCT05668208
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Trial Details
ClinicalTrials.gov โ€ข NCT05668208
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Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure?
Comparison of the Effects of Extraperitoneal and Transperitoneal Laparoscopic Surgeries on Intracranial Pressure: A Prospective Clinical Study

Study Focus

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

Interventional

device

Sponsor & Location

Konya City Hospital

Konya, Turkey

Timeline & Enrollment

N/A

Jan 06, 2023

Jan 20, 2023

60 participants

Primary Outcome

measurements of optic nerve sheath diameter (ONSD)

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.

ICD-10 Classifications

Benign intracranial hypertension
Intracranial injury
Intracranial injury, unspecified
Other intracranial injuries
Intracranial hypotension following ventricular shunting

Data Source

ClinicalTrials.gov

NCT05668208

Device Trial