About this trial
Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. The intent of this study is to determine if the x-ray component of this therapeutic approach is necessary.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Nausea
Emesis
Abdominal pain
Distended abdomen
Disqualifiers
Unable to provide consent for the study.
Pregnant or breastfeeding.
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 or stroke within 6 months
Trial design
Parallel
Treatments tested in this trial
Abdominal Radiography
Diagnostic testObtain plain film radiographs 3 times after adminstration of WSC
Treatment groups
Trial outcomes
Primary outcomes
Median number of days of benefit
probability distribution of the difference in median number of days of benefit attributable to the intervention determined from the posterior distribution of state occupancy probabilities.
Secondary outcomes
Daily Clinical Status
longitudinal, ordinal state transition analysis of a patient's clinical status on any day within a 30-day window
Health Care Quality of Life (HCQOL)
HCQOL as assessed by PROMIS-29: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has a physical function scale ranging from 30-56 with higher scores representing better physical function. Anxiety, depression, fatigue, sleep disturbance, social function, pain interference have scales ranging from a low of 30-40 and a high of 60-80 with higher scores representing worse outcomes. Pain intensity is measured on a scale of 0 to 10 with 10 representing more pain.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: