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

Intestinal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02928458
• Other study ID #: 1609-39
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: September 13, 2017

Study information

• Verified date: December 2018
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 13, 2017
• Est. primary completion date: September 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction

Intervention

Drug:
• Omnipaque

• MD-Gastroview

Locations

Country	Name	City	State
United States	The Guthrie Clinic	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.		Three years
Secondary	Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.		Three years