Small Bowel ObstructionNCT07099300
Water-Soluble Contrast Induced Intestinal Stimulation for the Treatment of Small Bowel Obstruction: A Feasibility Study
A study testing Abdominal Radiography in people with Small Bowel Obstruction, run by University of California, Los Angeles.
Trial summary
Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- Abdominal Radiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 15 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria:
- Nausea
- Emesis
- Abdominal pain
- Distended abdomen
- CT evidence of aSBO
- Known abdominal surgical history.
- Written informed consent obtained from subject.
Who cannot join
- Unable to provide consent for the study.
- Pregnant or breastfeeding.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Unstable angina or recent myocardial infarction or stroke within 6 months
- Patients with peritonitis or who require immediate surgery.
- Non-adhesive SBO, including.
Show all 11Show fewer
- Paralytic Ileus
- Incarcerated hernia
- Fecal impaction
- Intra-abdominal malignancy
- Early aSBO within 4 weeks of a prior abdominal operation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Use of Nasogastric Tubes and Water-Soluble Contrast With or Without Radiographic Imaging in The Management of Adhesive Small Bowel Obstruction: A Feasibility Study
Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. The intent of this study is to determine if the x-ray component of this therapeutic approach is necessary.
Read the detailed description
Responsible for more than 340,000 hospital admissions per year, small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. In most (60%) patients, aSBO resolves spontaneously. However, NGTs are uncomfortable for patients and have multiple associated risks, leading many patients and clinicians to avoid their use if possible.
Despite NGT placement being considered a standard component of aSBO treatment, some series report that as many as ½ of all patients with aSBO may be treated without them. A recent meta-analysis showed that hospital length-of-stay (HLOS) may be reduced by 2 days if treated with water-soluble contrast (WSC).
Despite aSBO being common, little is known about the optimal means for its treatment and even less about the mechanisms by which it resolves. The overall intent of this research is to develop evidence-based treatment protocols and to better understand the mechanisms by which aSBO resolves and how interventions can be developed to improve its treatment.
This feasibility study's purpose is to determine the ability to perform a randomized clinical trial (RCT) investigating treatments options for aSBO. Specifically, WSC will be administered to patients with a SBO followed by randomization to undergo formal upper gastrointestinal-small bowel follow through (UGI-SBFT) series vs no radiologic imaging to determine if radiologic examination can be eliminated when treating patients with aSBO. A concurrent observational arm will enroll patients who elect not to have NGTs placed to follow their hospital course. A state-transition model of daily clinical status will be tested to determine its effectiveness as a primary outcome to replace older, traditional outcomes for hospitalized patients such as diet resumption or length of stay.
- Conditions
- Small Bowel Obstruction
- Being tested
- Abdominal Radiography
- Keywords
- water soluble contrast, radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal RadiographyDiagnostic test
Obtain plain film radiographs 3 times after adminstration of WSC
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Experimental | Patients with SBO will undergo an initial WSC study but no subsequent x-rays will be obtained, Receives: Diagnostic Test: Abdominal Radiography |
| Control | Active comparator | Patients with SBO will undergo an initial WSC study and will have routine abdominal radiographs at 12, 24, and 48 hours. Receives: Diagnostic Test: Abdominal Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median number of days of benefit
probability distribution of the difference in median number of days of benefit attributable to the intervention determined from the posterior distribution of state occupancy probabilities.
Measured: 30 Days
Secondary outcomes (2)
Daily Clinical Status
longitudinal, ordinal state transition analysis of a patient's clinical status on any day within a 30-day window
Measured: 30 day
Health Care Quality of Life (HCQOL)
HCQOL as assessed by PROMIS-29: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has a physical function scale ranging from 30-56 with higher scores representing better physical function. Anxiety, depression, fatigue, sleep disturbance, social function, pain interference have scales ranging from a low of 30-40 and a high of 60-80 with higher scores representing worse outcomes. Pain intensity is measured on a scale of 0 to 10 with 10 representing more pain.
Measured: 30 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Aug 2030 (estimated)
- Study completion15 Aug 2030 (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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group, Randomized, Clinical Trail
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Harry Livingston, University of California, Los Angeles
- Investigators
- Edward H Livingston, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099300
- Sponsor's protocol ID
- 21-6143
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be of patients who are potentially identifiable. Data will not be publically available to protect their identities.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nasogastric Tubes and Water-Soluble Contrast With or Without Radiographic Imaging in The Management of Adhesive Small Bowel Obstruction: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07099300
- Acronym / sponsor ID
- 21-6143
- Conditions
- Small Bowel Obstruction
- Keywords
- water soluble contrast, radiology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Aug 2030 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 1 Aug 2025 (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.
Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. The intent of this study is to determine if the x-ray component of this therapeutic approach is necessary.
Detailed description
Responsible for more than 340,000 hospital admissions per year, small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. In most (60%) patients, aSBO resolves spontaneously. However, NGTs are uncomfortable for patients and have multiple associated risks, leading many patients and clinicians to avoid their use if possible.
Despite NGT placement being considered a standard component of aSBO treatment, some series report that as many as ½ of all patients with aSBO may be treated without them. A recent meta-analysis showed that hospital length-of-stay (HLOS) may be reduced by 2 days if treated with water-soluble contrast (WSC).
Despite aSBO being common, little is known about the optimal means for its treatment and even less about the mechanisms by which it resolves. The overall intent of this research is to develop evidence-based treatment protocols and to better understand the mechanisms by which aSBO resolves and how interventions can be developed to improve its treatment.
This feasibility study's purpose is to determine the ability to perform a randomized clinical trial (RCT) investigating treatments options for aSBO. Specifically, WSC will be administered to patients with a SBO followed by randomization to undergo formal upper gastrointestinal-small bowel follow through (UGI-SBFT) series vs no radiologic imaging to determine if radiologic examination can be eliminated when treating patients with aSBO. A concurrent observational arm will enroll patients who elect not to have NGTs placed to follow their hospital course. A state-transition model of daily clinical status will be tested to determine its effectiveness as a primary outcome to replace older, traditional outcomes for hospitalized patients such as diet resumption or length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Group, Randomized, Clinical Trail
| Arm | Type | Receives |
|---|---|---|
| Imaging | Experimental | Diagnostic Test: Abdominal RadiographyPatients with SBO will undergo an initial WSC study but no subsequent x-rays will be obtained, |
| Control | Active comparator | Diagnostic Test: Abdominal RadiographyPatients with SBO will undergo an initial WSC study and will have routine abdominal radiographs at 12, 24, and 48 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria:
- Written informed consent obtained from subject.
Key exclusion criteria (11 listed)
- Unable to provide consent for the study.
- Pregnant or breastfeeding.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Unstable angina or recent myocardial infarction or stroke within 6 months
- Patients with peritonitis or who require immediate surgery.
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 |
|---|---|---|
| Abdominal RadiographyObtain plain film radiographs 3 times after adminstration of WSC | Diagnostic test | Control, Imaging |
Primary outcome
Median number of days of benefit
Time frame: 30 Days
probability distribution of the difference in median number of days of benefit attributable to the intervention determined from the posterior distribution of state occupancy probabilities.
2 secondary outcomes
Daily Clinical Status
Time frame: 30 day
Health Care Quality of Life (HCQOL)
Time frame: 30 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No. The study will be of patients who are potentially identifiable. Data will not be publically available to protect their identities.
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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.
Edward H Livingston, MD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Radiography in people with Small Bowel Obstruction, run by University of California, Los Angeles.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward H Livingston, MD (818-461-3321, elivingston@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median number of days of benefit (time frame: 30 Days). 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 7 Aug 2025.