Morbid ObesityNCT04481880
Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity
An observational study of Morbid Obesity and Intra-Abdominal Hypertension, run by Rambam Health Care Campus.
Trial summary
The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbid Obesity, Intra-Abdominal Hypertension, Bariatric Surgery Candidate
- What is being tested?
- measuring IAP and respiratory parameters
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Adult, Older adult
Study population: adult subjects with morbid obesity
Who may be able to join
- age >18 years
- Morbid Obesity
- candidate for bariatric surgery
Who cannot join
- Contraindication to laparoscopy
- Advanced COPD
- Advanced CHF
About this study
The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed
Read the 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.
- Being tested
- measuring IAP and respiratory parameters
- Medical subject headings
- Obesity, Morbid, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring IAP and respiratory parametersDiagnostic test
Effect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between intra-abdominal pressure and gastric pressure
different measurement methods
Measured: Early post-operative- up to 1 week post operation
Intra-abdominal pressure
Correlation between measured IAP according to different measurement methods
Measured: 0-7 days post bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rambam75, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481880
- Sponsor's protocol ID
- Rambam ethics number: 0019-12
- Status last verified
- Jul 2020
- First submitted
- 22 Mar 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT04481880
- Acronym / sponsor ID
- Rambam ethics number: 0019-12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult subjects with morbid obesity
Key inclusion criteria (3 listed)
- age >18 years
- Morbid Obesity
- candidate for bariatric surgery
Key exclusion criteria (3 listed)
- Contraindication to laparoscopy
- Advanced COPD
- Advanced CHF
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 |
|---|---|---|
| measuring IAP and respiratory parametersEffect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures | Diagnostic test | – |
Primary outcome
correlation between intra-abdominal pressure and gastric pressure
Time frame: Early post-operative- up to 1 week post operation
different measurement methods
Intra-abdominal pressure
Time frame: 0-7 days post bariatric surgery
Correlation between measured IAP according to different measurement methods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Intra-Abdominal Hypertension, run by Rambam Health Care Campus.
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 3 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation between intra-abdominal pressure and gastric pressure (time frame: Early post-operative- up to 1 week post operation). The study lists 2 primary outcomes in all. 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 22 Jul 2020.