Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

NCT ID: NCT05070572

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intra-Abdominal Hypertension Inguinal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Accuryn Monitoring System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Potrero Medical

INDUSTRY

Sponsor Role collaborator

Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christopher Prien

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2021-05-02-MMC

Identifier Type: -

Identifier Source: org_study_id

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