- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481880
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rambam ethics number: 0019-12
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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