Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity

July 19, 2020 updated by: rambam75, Rambam Health Care Campus
The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed

Study Overview

Detailed Description

Intra-abdominal pressure (IAP) affects cardio-respiratory hemodynamics and can be assessed either directly, or by measuring gastric or urinary bladder pressure. However, in patients with morbid obesity, the correlations between gastric and urinary bladder pressures with IAP have not been addressed. The investigator's aim was to assess the correlations between IAP and gastric and urinary bladder pressure in patients with morbid obesity, at normal and elevated levels of IAP, and to examine the effects of increasing IAP and patient position on hemodynamic and respiratory parameters.

Study Type

Observational

Enrollment (Actual)

12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult subjects with morbid obesity

Description

Inclusion Criteria:

  • age >18 years
  • Morbid Obesity
  • candidate for bariatric surgery

Exclusion Criteria:

  • Contraindication to laparoscopy
  • Advanced COPD
  • Advanced CHF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between intra-abdominal pressure and gastric pressure
Time Frame: Early post-operative- up to 1 week post operation
different measurement methods
Early post-operative- up to 1 week post operation
Intra-abdominal pressure
Time Frame: 0-7 days post bariatric surgery
Correlation between measured IAP according to different measurement methods
0-7 days post bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 22, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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