Summary

Eligibility
for people ages 18-80 (full criteria)
Dates
study started
study ends around
Principal Investigator
by Edward H Livingston, MD

Description

Summary

Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. The intent of this study is to determine if the x-ray component of this therapeutic approach is necessary.

Details

Responsible for more than 340,000 hospital admissions per year, small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. In most (60%) patients, aSBO resolves spontaneously. However, NGTs are uncomfortable for patients and have multiple associated risks, leading many patients and clinicians to avoid their use if possible. Despite NGT placement being considered a standard component of aSBO treatment, some series report that as many as ½ of all patients with aSBO may be treated without them. A recent meta-analysis showed that hospital length-of-stay (HLOS) may be reduced by 2 days if treated with water-soluble contrast (WSC).

Despite aSBO being common, little is known about the optimal means for its treatment and even less about the mechanisms by which it resolves. The overall intent of this research is to develop evidence-based treatment protocols and to better understand the mechanisms by which aSBO resolves and how interventions can be developed to improve its treatment.

This feasibility study's purpose is to determine our ability to perform an RCT investigating treatments options for aSBO. Specifically, we will administer WSC to patients with a SBO followed by randomization to undergo formal upper gastrointestinal-small bowel follow through (UGI-SBFT) series vs no radiologic imaging to determine if radiologic examination can be eliminated when treating patients with aSBO. A concurrent observational arm will enroll patients who elect not to have NGTs placed to follow their hospital course. We will also test a state-transition model of daily clinical status as the primary outcome to replace older, traditional outcomes for hospitalized patients such as diet resumption or length of stay.

Keywords

Small Bowel Obstruction, water soluble contrast, radiology, Intestinal Obstruction, Abdominal Radiography, Imaging

Eligibility

You can join if…

Open to people ages 18-80

Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria:

Nausea, emesis, abdominal pain, distended abdomen CT evidence of aSBO Known abdominal surgical history. Written informed consent obtained from subject.

You CAN'T join if...

Unable to provide consent for the study. Pregnant or breastfeeding. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

Unstable angina or recent MI/stroke within 6 months Patients with peritonitis or who require immediate surgery. Non-adhesive SBO, including. Paralytic Ileus Incarcerated hernia Fecal impaction Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07099300
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated