Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol
Primary Purpose
Intestinal Obstruction
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnipaque
MD-Gastroview
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Obstruction
Eligibility Criteria
Inclusion Criteria:
- Principle diagnosis of adhesive small bowel obstruction
Exclusion Criteria:
- Evidence of strangulation on initial CT scan leading to emergent operation
- Any known allergy to either contrast agent
Sites / Locations
- The Guthrie Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Omnipaque
MD-Gastroview
Arm Description
Arm 1
Arm 2
Outcomes
Primary Outcome Measures
Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.
Secondary Outcome Measures
Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02928458
Brief Title
Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol
Official Title
Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate enrollment
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 13, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Guthrie Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omnipaque
Arm Type
Active Comparator
Arm Description
Arm 1
Arm Title
MD-Gastroview
Arm Type
Active Comparator
Arm Description
Arm 2
Intervention Type
Drug
Intervention Name(s)
Omnipaque
Intervention Type
Drug
Intervention Name(s)
MD-Gastroview
Primary Outcome Measure Information:
Title
Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Principle diagnosis of adhesive small bowel obstruction
Exclusion Criteria:
Evidence of strangulation on initial CT scan leading to emergent operation
Any known allergy to either contrast agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Behm, MD
Organizational Affiliation
The Guthrie Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Guthrie Clinic
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol
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