NCT02928458

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2017

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

July 18, 2016

Last Update Submit

December 3, 2018

Conditions

Intestinal Obstruction

Outcome Measures

Primary Outcomes (1)

  • Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.

    Three years

Secondary Outcomes (1)

  • Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.

    Three years

Study Arms (2)

Omnipaque

ACTIVE COMPARATOR

Arm 1

Drug: Omnipaque

MD-Gastroview

ACTIVE COMPARATOR

Arm 2

Drug: MD-Gastroview

Interventions

OmnipaqueDRUG
Omnipaque
MD-GastroviewDRUG
MD-Gastroview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Principle diagnosis of adhesive small bowel obstruction

You may not qualify if:

  • Evidence of strangulation on initial CT scan leading to emergent operation
  • Any known allergy to either contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

IohexolDiatrizoate

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Robert Behm, MD

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

October 10, 2016

Study Start

September 1, 2015

Primary Completion

September 13, 2017

Study Completion

September 13, 2017

Last Updated

December 4, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)