Optimizing Treatment of Adhesive Small Bowel Obstruction
ConditionAdhesive Small Bowel Obstruction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Gastrografin
- Saline
- SBO Treatment Without NG Tubes
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov