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

NCT07099300 | Not Yet Recruiting

• 1 other identifier: 21-6143
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Small Bowel Obstruction

Keywords

water soluble contrast; radiology

Outcome Measures

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.

  30 Days

Secondary Outcomes (2)

• Daily Clinical Status

  30 day

• Health Care Quality of Life (HCQOL)

  30 Day

Study Arms (2)

Imaging

EXPERIMENTAL

Patients with SBO will undergo an initial WSC study but no subsequent x-rays will be obtained,

Diagnostic Test: Abdominal Radiography

Control

ACTIVE COMPARATOR

Patients with SBO will undergo an initial WSC study and will have routine abdominal radiographs at 12, 24, and 48 hours.

Diagnostic Test: Abdominal Radiography

Interventions

Abdominal Radiography DIAGNOSTIC_TEST

Obtain plain film radiographs 3 times after adminstration of WSC

Control; Imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Known abdominal surgical history.
• Written informed consent obtained from subject.

You may not qualify if:

• 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
• Patients with peritonitis or who require immediate surgery.
• Non-adhesive SBO, including.
• Paralytic Ileus
• Incarcerated hernia
• Fecal impaction
• Intra-abdominal malignancy
• Early aSBO within 4 weeks of a prior abdominal operation

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Interventions

Radiography, Abdominal

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Edward H Livingston, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward H Livingston, MD

CONTACT

818-461-3321; elivingston@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Parallel Group, Randomized, Clinical Trail

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2030
• Study Completion (Estimated): August 15, 2030
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share