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Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure?

Primary Purpose

Intracranial Pressure Increase

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)
Sponsored by
Konya City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Pressure Increase focused on measuring intracranial pressure, laparoscopic, transperitoneally, extraperitoneal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-70 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. Exclusion Criteria: 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.

Sites / Locations

  • University of Health Science Konya City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

extraperitoneal surgery group - TEP inguinal hernia repair

transperitoneal surgery group - laparoscopic cholecystectomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

measurements of optic nerve sheath diameter (ONSD)
mm

Secondary Outcome Measures

heart rate value
/min
blood pressure
mmHg
SPO2 measurements
ETCO2 measurements
mmHg

Full Information

First Posted
December 11, 2022
Last Updated
March 11, 2023
Sponsor
Konya City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05668208
Brief Title
Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure?
Official Title
Comparison of the Effects of Extraperitoneal and Transperitoneal Laparoscopic Surgeries on Intracranial Pressure: A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A total of 60 patients, including 30 patients who underwent laparoscopic cholecystectomy and 30 patients who underwent TEP inguinal hernia repair between December 2022 and January 2023, were included in the study. Inclusion criteria: 18-70 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. Exclusion criteria: patients who were switched to open surgery, glaucoma, corneal disease, eye surgery, cerebrovascular disease, any neurological disease, chronic kidney disease, liver cirrhosis, and patients whose peritoneum was opened during TEP. Anesthesia All patients will undergo general anesthesia and will be given Propofol 2 mg/kg and Fentanyl 2 μg/kg intravenously (IV) for analgesia. Endotracheal intubation will be performed after a 4-minute injection of 0.1 mg/kg Vecuronium. Anesthesia will be maintained with an oxygen-air ratio of 50:50 propofol. For postoperative nausea and vomiting prophylaxis, 4 mg of dexamethasone will be given at induction. Intermittent doses of Fentanyl and Vecuronium will be given from time to time as needed. At the end of the surgery, the neuromuscular paralysis will be reversed with 0.05 mg/kg Neostigmine and 0.02 mg/kg Glycopyrrolate Injection, and the patient will be extubated. Surgical Method in Patients Undergoing Laparoscopic Cholecystectomy: With a mini incision made under the umbilicus, the abdomen will be entered with a 10 mm trocar. Pneumoperitoneum will be created with CO2 gas. The intra-abdominal pressure will be set to 14 mmHg. Under the guidance of the laparoscope, 1 10 mm trocar from the subxiphoid region and 2 more 5 mm trocars from the subcostal region will be inserted. The cystic artery and cystic duct will be clipped and cut, exposing the Callot's triangle. The gallbladder will then be separated from the liver bed and removed through the abdomen. The CO2 in the abdomen will be evacuated and the trocars will be removed. The operation will be terminated by closing the fascia defect and the skin. Surgical Method in Patients with Totally Extra-peritoneal (TEP) Repair: The outer sheath of the rectus muscle will be seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus. A 10 mm trocar will be placed in the preperitoneal space and CO2 insufflation will be applied. The pressure will be set to 14 mmHg. Two more 5 mm trocars will be placed between the umbilicus and the sympisis pubis under the laparoscope. The preperitoneal inguinal region will be dissected with a laparoscopic dissector and holder. The hernial sac will be released. A 10x15 cm prolene mesh will be fixed to cover the femoral, direct and indirect hernia areas. The trocars will be removed by evacuating the CO2 gas. The skin will be closed and the operation will be terminated. Results The primary outcome of the study is the comparison of ONSD measurements between patients who underwent laparoscopic cholecystectomy and TEP repair. Secondary outcomes are age, gender, ASA score, height, weight, comorbidities, heart rate, blood pressure, oxygen saturation (SpO2), end tidal CO2 (ETCO2) measurements. ONSD measurement: ONSD will be performed with transorbital sonography by 2 investigators unaware of the study protocol. Transorbital sonography will be performed using an E-CUBE i7 ultrasound system (mechanical index, 0.2; thermal index, 0) using a linear 6-13 Hz probe (Alpinion Medical Systems, Seoul, Republic of Korea). To prevent eye damage, a sterile occlusion gel will be used and gently probed without applying pressure to the eyelid. Ultrasonographic images of the area will be obtained at the optic nerve level and the ONSD image will be taken 3 mm behind the optic nerve head. The optic nerve sheath will be taken from both eyes at certain times, preoperatively (T0), at the end of insufflation (T1), and at the end of the operation (T2). The average value of the 3 measurements will be recorded as ONSD. Heart rate (HR), blood pressure, SPO2 and EtCO2 will be recorded separately at each time point. Statistical analysis The primary aim of this study is to compare the effect of laparoscopic surgeries performed in the preperitoneal and intraperitoneal areas on OSD. For clinically reliable results, at least 30 subjects in each group had to detect a difference of 0.3 mm in ONSD measurements. Sample size was calculated based on a pilot study. Multivariate observational analyzes of all data will be performed. Descriptive statistics will be given for hidden variables. Mean and standard deviation will be given for continuous variables, frequency and percentage will be given for categorical variables. Mixed effects models will be created for constant variables. Group, time and group-time interaction will be evaluated. The t-test will be used to measure continuous variables between the 2 groups. When group-time interaction is important, least squares means will be compared. Statistical Analysis SAS (University Edition 9.4) software will be used for data analysis. A P value of <0.05 will be considered significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase
Keywords
intracranial pressure, laparoscopic, transperitoneally, extraperitoneal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extraperitoneal surgery group - TEP inguinal hernia repair
Arm Type
Experimental
Arm Description
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.
Arm Title
transperitoneal surgery group - laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)
Intervention Description
ONSD measurement will be made using the E-CUBE i7 ultrasound system.
Primary Outcome Measure Information:
Title
measurements of optic nerve sheath diameter (ONSD)
Description
mm
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
heart rate value
Description
/min
Time Frame
during surgery
Title
blood pressure
Description
mmHg
Time Frame
during surgery
Title
SPO2 measurements
Time Frame
during surgery
Title
ETCO2 measurements
Description
mmHg
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-70 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Health Science Konya City Hospital
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28722845
Citation
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/
Results Reference
background
PubMed Identifier
31813477
Citation
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.
Results Reference
background
PubMed Identifier
9660022
Citation
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.
Results Reference
background
PubMed Identifier
31617096
Citation
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.
Results Reference
background
PubMed Identifier
27956677
Citation
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.
Results Reference
background
PubMed Identifier
20167583
Citation
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.
Results Reference
background
PubMed Identifier
11445709
Citation
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.
Results Reference
background
PubMed Identifier
9094281
Citation
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.
Results Reference
background
PubMed Identifier
25899811
Citation
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.
Results Reference
background

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Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure?

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