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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Gastrografin
DrugAdministration of WSC (Gastrografin) 2 hours after placement of NGT.
Saline
DrugAdministration of Saline 2 hours after placement of NGT.
SBO Treatment Without NG Tubes
Procedure/SurgeryPatients who decline to have NG tubes placed will be enrolled and followed with the same outcomes protocol as the other patients in the trial
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: SBO treated without NG tubeExperimental treatment 1 intervention
Group B: SBO treated with NG tube and Water-Soluble Contrast (WSC)Experimental treatment 1 intervention
Group C: SBO Treated with NG tube and PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS®)-29
Quality of life will be assessed using the PROMIS-29 HRQOL instrument. The survey uses multiple response formats. A total score provides an index of HRQOL, with higher scores on a scale of 0-100 reflecting better HRQOL.
Time frame
The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge.Sponsors and contacts
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Source ClinicalTrials.gov