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NCT05070572 Clinical Trial

Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

Inguinal Hernia Clinical Trial

Official title:
Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output in Obese Individuals Undergoing Laparoscopic Inguinal Hernia Repair

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05070572
Other study ID # 2021-05-02-MMC
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 30, 2022

Study information
Verified date July 2022
Source Maimonides Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. By measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of IAP during laparoscopic hernia surgery using the Accuryn Monitoring System. By obtaining accurate and precise measurements of IAP during surgery the investigators will be to compare measurements to previous IAP data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 25
Est. completion date December 30, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Obese with BMI > 30 - Diagnosis of inguinal hernia - Qualify for laparoscopic inguinal hernia repair Exclusion Criteria: - Previous bowel resections resulting in short bowel - Extensive abdominal scarring - BMI < 30 - Fail to qualify for laparoscopic inguinal hernia repair

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Accuryn Monitoring System
Utilization of the Accuryn Monitoring System to measure intraabdominal pressure and urine output during laparoscopic inguinal hernia repair surgery.

Locations
Country Name City State
United States Maimonides Medical Center Brooklyn New York

Sponsors (2)
Lead Sponsor Collaborator
Maimonides Medical Center Potrero Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraabdominal Pressure Maximum IAP levels during surgery 2 hours
See also
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