Small Bowel ObstructionNCT01934283
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
A study testing urine folly catheter in people with Small Bowel Obstruction, run by Meir Medical Center at 1 site in Israel.
Trial summary
Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- urine folly catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 , diagnosis of small bowel obstruction
Who cannot join
- younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kfar Saba
ronen ghinea, MD, 972544388990, rghinea@hotmail.com
About this study
Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery.
Some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction.
Read more
The pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.
In this study we will measure the intra-abdominal pressure in SBO patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.
- Conditions
- Small Bowel Obstruction
- Being tested
- urine folly catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine folly catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| operated patients | No intervention | small bowel obstrucion patients who needed surgery for treatment of obstruction. Receives: Device: urine folly catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra abdominal pressure
serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934283
- Sponsor's protocol ID
- mmc-0188-12
- Status last verified
- Aug 2013
- First submitted
- 27 Feb 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
- ClinicalTrials.gov ID
- NCT01934283
- Acronym / sponsor ID
- mmc-0188-12
- Conditions
- Small Bowel Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Sep 2013 (estimated)
- 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.
Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery.
Some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction.
The pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.
In this study we will measure the intra-abdominal pressure in SBO patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operated patients | No intervention | Device: urine folly cathetersmall bowel obstrucion patients who needed surgery for treatment of obstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older than 18 , diagnosis of small bowel obstruction
Key exclusion criteria (1 listed)
- younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia
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 |
|---|---|---|
| urine folly catheter | Device | operated patients |
Primary outcome
intra abdominal pressure
Time frame: up to 1 week
serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine folly catheter in people with Small Bowel Obstruction, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Sep 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ronen ghinea, MD (972544388990, rghinea@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra abdominal pressure (time frame: up to 1 week). 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 4 Sep 2013.