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Optimizing Treatment of Adhesive Small Bowel Obstruction

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Brief 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.
Primary Purpose
Treatment
Study Type
Interventional
Phase
Pilot/Feasibility

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Male or female ≥18 years of age.
  • 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:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • 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 myocardial infarction (MI)/stroke within 6 months
  • Nonadhesive SBO
    • Paralytic Ileus
    • Incarcerated hernia
    • Fecal impaction
    • Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation

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Study Stats
Protocol No.
23-001055
Category
GI Disorders
Contact
Facundo Bianchetti-Castro
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT06182319
For detailed technical eligibility, visit ClinicalTrials.gov.