Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol

NCT ID: NCT02928458

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2017-09-13

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.

Conditions

Intestinal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Omnipaque

Arm 1

Group Type: ACTIVE_COMPARATOR

Omnipaque

Intervention Type: DRUG

MD-Gastroview

Arm 2

Group Type: ACTIVE_COMPARATOR

MD-Gastroview

Intervention Type: DRUG

Interventions

Omnipaque

Intervention Type: DRUG

MD-Gastroview

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Guthrie Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Behm, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

The Guthrie Clinic

Sayre, Pennsylvania, United States

Countries

United States

Other Identifiers

1609-39

Identifier Type: -

Identifier Source: org_study_id