Water-Soluble Contrast Induced Intestinal Stimulation for the Treatment of Small Bowel Obstruction: A Feasibility Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, Los Angeles

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Abdominal Radiography

    Diagnostic test

    Obtain plain film radiographs 3 times after adminstration of WSC

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ImagingExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 Days

Secondary outcomes

1

Daily Clinical Status

longitudinal, ordinal state transition analysis of a patient's clinical status on any day within a 30-day window

Time frame
30 day
2

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.

Time frame
30 Day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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