NCT06182319PHASE3Recruiting

Optimizing Treatment of Adhesive Small Bowel Obstruction

University of California, Los Angeles

Start Date

1/1/2024

Completion Date

12/15/2025

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Gastrografin

DRUG

Saline

PROCEDURE

SBO Treatment Without NG Tubes

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Conditions

Adhesive Small Bowel Obstruction

Locations

University of California, Los Angeles, David Geffen School of Medicine

Los Angeles, California 90024

United States