Intestinal ObstructionNCT02928458
Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol
A study testing Omnipaque and MD-Gastroview in people with Intestinal Obstruction, run by The Guthrie Clinic at 1 site in United States.
Trial summary
This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a condition in which the small intestine gets blocked due to scars called adhesions. To see the blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Obstruction
- What is being tested?
- Omnipaque and MD-Gastroview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 13 Sep 2017
- 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
- Principle diagnosis of adhesive small bowel obstruction
Who cannot join
- Evidence of strangulation on initial CT scan leading to emergent operation
- Any known allergy to either contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a condition in which the small intestine gets blocked due to scars called adhesions. To see the blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). MD Gastroview and omnipaque are two contrast agents that may be given as part of your normal care for ASBO. This study hopes to see if one is better than the other.
Read the detailed description
Small bowel obstruction is a common general surgical diagnosis providing a significant proportion (16%) of the emergency general surgery admissions. Unfortunately, there is a paucity of clear, well defined management protocols for this very common problem which results in a wide array of management techniques used by the general surgeon. It has already been shown that CT scan with IV contrast is the most accurate method of identifying strangulated bowel, a diagnosis that requires urgent surgical intervention(4). There is no variability in this aspect of the treatment arm for ASBO, rather the variability is found in the medical management of ASBO. Nasogastric tube (NGT) decompression is a universal component of non-operative management but the duration of NGT therapy and the definition of failed medical management requiring surgery lack a clear consensus. It is this aspect of the management of ASBO that I am hoping to better define. Water soluble contrast (MD-Gastroview) has been shown to be both diagnostic and therapeutic in the management of ASBO decreasing length of stay in this patient population. Not only does it expedite the resolution of ASBO, but is also yields objective evidence whether or not ASBO will resolve with medical management alone, therefore decreasing delay in the inevitable surgical intervention.
The hypothesis of this study is that the implementation of an evidence based adhesive small bowel obstruction protocol can reduce length of stay and reduce the financial burden on the health care system regarding this common general surgical problem. A second hypothesis is that MD-Gastroview and omnipaque will have similar properties regarding their diagnostic and therapeutic impact on ASBO.
- Conditions
- Intestinal Obstruction
- Being tested
- Omnipaque, MD-Gastroview
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnipaqueDrug
MD-GastroviewDrug
| Study group | Role | What they receive |
|---|---|---|
| Omnipaque | Active comparator | Arm 1 Receives: Drug: Omnipaque |
| MD-Gastroview | Active comparator | Arm 2 Receives: Drug: MD-Gastroview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.
Measured: Three years
Secondary outcomes (1)
Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start1 Sep 2015
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Behm, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928458
- Sponsor's protocol ID
- 1609-39
- Status last verified
- Dec 2018
- First submitted
- 18 Jul 2016
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol
- ClinicalTrials.gov ID
- NCT02928458
- Acronym / sponsor ID
- 1609-39
- Conditions
- Intestinal Obstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 10 Oct 2016 (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.
This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a condition in which the small intestine gets blocked due to scars called adhesions. To see the blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). MD Gastroview and omnipaque are two contrast agents that may be given as part of your normal care for ASBO. This study hopes to see if one is better than the other.
Detailed description
Small bowel obstruction is a common general surgical diagnosis providing a significant proportion (16%) of the emergency general surgery admissions. Unfortunately, there is a paucity of clear, well defined management protocols for this very common problem which results in a wide array of management techniques used by the general surgeon. It has already been shown that CT scan with IV contrast is the most accurate method of identifying strangulated bowel, a diagnosis that requires urgent surgical intervention(4). There is no variability in this aspect of the treatment arm for ASBO, rather the variability is found in the medical management of ASBO. Nasogastric tube (NGT) decompression is a universal component of non-operative management but the duration of NGT therapy and the definition of failed medical management requiring surgery lack a clear consensus. It is this aspect of the management of ASBO that I am hoping to better define. Water soluble contrast (MD-Gastroview) has been shown to be both diagnostic and therapeutic in the management of ASBO decreasing length of stay in this patient population. Not only does it expedite the resolution of ASBO, but is also yields objective evidence whether or not ASBO will resolve with medical management alone, therefore decreasing delay in the inevitable surgical intervention.
The hypothesis of this study is that the implementation of an evidence based adhesive small bowel obstruction protocol can reduce length of stay and reduce the financial burden on the health care system regarding this common general surgical problem. A second hypothesis is that MD-Gastroview and omnipaque will have similar properties regarding their diagnostic and therapeutic impact on ASBO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnipaque | Active comparator | Drug: OmnipaqueArm 1 |
| MD-Gastroview | Active comparator | Drug: MD-GastroviewArm 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Principle diagnosis of adhesive small bowel obstruction
Key exclusion criteria (2 listed)
- Evidence of strangulation on initial CT scan leading to emergent operation
- Any known allergy to either contrast agent
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 |
|---|---|---|
| Omnipaque | Drug | Omnipaque |
| MD-Gastroview | Drug | MD-Gastroview |
Primary outcome
Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.
Time frame: Three years
1 secondary outcome
Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.
Time frame: Three years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Robert Behm, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipaque and MD-Gastroview in people with Intestinal Obstruction, run by The Guthrie Clinic at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 4 Dec 2018. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol. (time frame: Three years). 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 Dec 2018.