Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

• Sponsor: Maimonides Medical Center (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05070572
• Collaborator: Potrero Medical (Industry)
• Enrollment: 25
• Location: 1
• Anticipated Duration (Months): 23.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intra-Abdominal Hypertension; Inguinal Hernia	Device: Accuryn Monitoring System

Study Design

• Study Type: Observational
• Anticipated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output in Obese Individuals Undergoing Laparoscopic Inguinal Hernia Repair
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Outcome Measures

Primary Outcome Measures

1. Intraabdominal Pressure [2 hours]

   Maximum IAP levels during surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Maimonides Medical Center
• Potrero Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Prien, Principal Investigator, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT05070572
• Other Study ID Numbers: 2021-05-02-MMC
• First Posted: Oct 7, 2021
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intra-Abdominal Hypertension; Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Jul 19, 2022