Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inguinal Hernia; Intra-Abdominal Hypertension
• Intervention / Treatment: Device: Accuryn Monitoring System

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be derived from the elective, outpatient surgical practice of the department of general surgery at Maimonides Medical Center.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraabdominal Pressure	Maximum IAP levels during surgery	2 hours

Collaborators and Investigators

• Sponsor: Maimonides Medical Center
• Collaborators: Potrero Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (ACTUAL): October 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Compartment Syndromes; Hernia; Hernia, Inguinal; Intra-Abdominal Hypertension
• Other Study ID Numbers: 2021-05-02-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No