Intra-Abdominal HypertensionNCT05070572
Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output
An observational study of Intra-Abdominal Hypertension and Inguinal Hernia, run by Antonios Likourezos at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intra-Abdominal Hypertension, Inguinal Hernia
- What is being tested?
- Accuryn Monitoring System
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Apr 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study population will be derived from the elective, outpatient surgical practice of the department of general surgery at Maimonides Medical Center.
Who may be able to join
- Obese with BMI > 30
- Diagnosis of inguinal hernia
- Qualify for laparoscopic inguinal hernia repair
Who cannot join
- Previous bowel resections resulting in short bowel
- Extensive abdominal scarring
- BMI < 30
- Fail to qualify for laparoscopic inguinal hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intra-Abdominal Hypertension, Inguinal Hernia
- Being tested
- Accuryn Monitoring System
- Medical subject headings
- Intra-Abdominal Hypertension, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuryn Monitoring SystemDevice
Utilization of the Accuryn Monitoring System to measure intraabdominal pressure and urine output during laparoscopic inguinal hernia repair surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraabdominal Pressure
Maximum IAP levels during surgery
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Jan 2021
- Primary completion31 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Collaborators
- Potrero Medical
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070572
- Sponsor's protocol ID
- 2021-05-02-MMC
- Status last verified
- Dec 2023
- First submitted
- 27 Sep 2021
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output in Obese Individuals Undergoing Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05070572
- Acronym / sponsor ID
- 2021-05-02-MMC
- Conditions
- Intra-Abdominal Hypertension, Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Collaborators
- Potrero Medical
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be derived from the elective, outpatient surgical practice of the department of general surgery at Maimonides Medical Center.
Key inclusion criteria (3 listed)
- Obese with BMI > 30
- Diagnosis of inguinal hernia
- Qualify for laparoscopic inguinal hernia repair
Key exclusion criteria (4 listed)
- Previous bowel resections resulting in short bowel
- Extensive abdominal scarring
- BMI < 30
- Fail to qualify for laparoscopic inguinal hernia repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuryn Monitoring SystemUtilization of the Accuryn Monitoring System to measure intraabdominal pressure and urine output during laparoscopic inguinal hernia repair surgery. | Device | – |
Primary outcome
Intraabdominal Pressure
Time frame: 2 hours
Maximum IAP levels during surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Hypertension and Inguinal Hernia, run by Antonios Likourezos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraabdominal Pressure (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.