Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

NCT05070572 | Completed Results

• 1 other identifier: 2021-05-02-MMC
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Intra-Abdominal Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraabdominal Pressure

  Maximum IAP levels during surgery

  2 hours

Interventions

Accuryn Monitoring System DEVICE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Obese with BMI \> 30
• Diagnosis of inguinal hernia
• Qualify for laparoscopic inguinal hernia repair

You may not qualify if:

• Previous bowel resections resulting in short bowel
• Extensive abdominal scarring
• BMI \< 30
• Fail to qualify for laparoscopic inguinal hernia repair

Sponsors & Collaborators

• Potrero Medical: collaborator
• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christopher Prien
• Organization: Maimonides Medical Center

DSherwinter@maimonidesmed.org

718-283-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: January 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: April 30, 2023
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)