Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure?

NCT05668208 | Completed

• 1 other identifier: 22222222
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Pressure Increase

Keywords

intracranial pressure; laparoscopic; transperitoneally; extraperitoneal

Outcome Measures

Primary Outcomes (1)

• measurements of optic nerve sheath diameter (ONSD)

  mm

  during surgery

Secondary Outcomes (4)

• heart rate value

  during surgery

• blood pressure

  during surgery

• SPO2 measurements

  during surgery

• ETCO2 measurements

  during surgery

Study Arms (2)

extraperitoneal surgery group - TEP inguinal hernia repair

EXPERIMENTAL

The external sheath of the rectus muscle was seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus edge. A 10 mm trocar was placed in the preperitoneal area and CO2 insufflation was performed. The pressure was set to 14 mmHg. Two more 5 mm trocars were inserted between the umbilicus and the sympisis pubis under the laparoscope. The preperitoneal inguinal area was dissected with a laparoscopic dissector and grasper. The hernia sac was released. A 10x15 cm prolene mesh was spread and fixed to cover the femoral, direct and indirect hernia areas. The trocars were removed by evacuating the CO2 gas. The skin was closed and the operation was terminated.

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

transperitoneal surgery group - laparoscopic cholecystectomy

ACTIVE COMPARATOR

With a mini incision made under the umbilicus, the abdomen was entered with a 10 mm trocar. Pneumoperitoneum was created with CO2 gas. Intra-abdominal pressure was set to 14 mmHg. Under the guidance of the laparoscope, one 10 mm trocar from the subxiphoid area and two more 5 mm trocars from the subcostal area were inserted. The cystic artery and cystic duct were clipped and cut by exposing the Callot triangle. Then the gallbladder was separated from the liver bed and taken out of the abdomen. The CO2 in the abdomen was evacuated and the trocars were removed. The fascia defect and skin were closed and the operation was terminated.

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

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.

extraperitoneal surgery group - TEP inguinal hernia repair; transperitoneal surgery group - laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,
• ASA (American Society of Anesthesiologists) I-II,
• patients who will undergo laparoscopic cholecystectomy with the diagnosis of symptomatic cholelithiasis or TEP due to inguinal hernia.

You may not qualify if:

• patients who were switched to open surgery,
• glaucoma, corneal disease, eye surgery,
• cerebrovascular disease,
• any neurological disease,
• chronic kidney disease,
• liver cirrhosis,
• patients whose peritoneum was opened during TEP.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

University of Health Science Konya City Hospital

Konya, Turkey (Türkiye)

Location

Related Publications (9)

• Steiner CA, Karaca Z, Moore BJ, Imshaug MC, Pickens G. Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014. 2017 May [updated 2020 Jul 20]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #223. Available from http://www.ncbi.nlm.nih.gov/books/NBK442035/

  PMID: 28722845 BACKGROUND

• Montorfano L, Giambartolomei G, Funes DR, Lo Menzo E, Dip F, White KP, Rosenthal RJ. The Cushing reflex and the vasopressin-mediated hemodynamic response to increased intracranial pressure during acute elevations in intraabdominal pressure. Surgery. 2020 Feb;167(2):478-483. doi: 10.1016/j.surg.2019.10.006. Epub 2019 Dec 6.

  PMID: 31813477 BACKGROUND

• Rosenthal RJ, Friedman RL, Chidambaram A, Khan AM, Martz J, Shi Q, Nussbaum M. Effects of hyperventilation and hypoventilation on PaCO2 and intracranial pressure during acute elevations of intraabdominal pressure with CO2 pneumoperitoneum: large animal observations. J Am Coll Surg. 1998 Jul;187(1):32-8. doi: 10.1016/s1072-7515(98)00126-4.

  PMID: 9660022 BACKGROUND

• Yashwashi T, Kaman L, Kajal K, Dahiya D, Gupta A, Meena SC, Singh K, Reddy A. Effects of low- and high-pressure carbon dioxide pneumoperitoneum on intracranial pressure during laparoscopic cholecystectomy. Surg Endosc. 2020 Oct;34(10):4369-4373. doi: 10.1007/s00464-019-07207-w. Epub 2019 Oct 15.

  PMID: 31617096 BACKGROUND

• Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.

  PMID: 27956677 BACKGROUND

• Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.

  PMID: 20167583 BACKGROUND

• Citerio G, Vascotto E, Villa F, Celotti S, Pesenti A. Induced abdominal compartment syndrome increases intracranial pressure in neurotrauma patients: a prospective study. Crit Care Med. 2001 Jul;29(7):1466-71. doi: 10.1097/00003246-200107000-00027.

  PMID: 11445709 BACKGROUND

• Rosenthal RJ, Hiatt JR, Phillips EH, Hewitt W, Demetriou AA, Grode M. Intracranial pressure. Effects of pneumoperitoneum in a large-animal model. Surg Endosc. 1997 Apr;11(4):376-80. doi: 10.1007/s004649900367.

  PMID: 9094281 BACKGROUND

• Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R. Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.

  PMID: 25899811 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (MD)

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 29, 2022
• Study Start: January 6, 2023
• Primary Completion: January 15, 2023
• Study Completion: January 20, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)