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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Withdrawn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
The Guthrie Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 18, 2016
Last Updated
December 3, 2018
Sponsor
The Guthrie Clinic
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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Withdrawn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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