Overview

Optimizing Treatment of Adhesive Small Bowel Obstruction

Status:
Recruiting
Trial end date:
2025-12-15
Target enrollment:
0
Participant gender:
All
Summary
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. The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO. This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Los Angeles
Criteria
Inclusion Criteria:

1. Male or female ≥18 years of age.

2. 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

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study.

2. 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.

3. Unstable angina or recent myocardial infarction (MI)/stroke within 6 months

4. Nonadhesive SBO

1. Paralytic Ileus

2. Incarcerated hernia

3. Fecal impaction

4. Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal
operation