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

NCT ID: NCT07099300

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2030-08-15

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.

Detailed Description

Responsible for more than 340,000 hospital admissions per year, 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. In most (60%) patients, aSBO resolves spontaneously. However, NGTs are uncomfortable for patients and have multiple associated risks, leading many patients and clinicians to avoid their use if possible.

Despite NGT placement being considered a standard component of aSBO treatment, some series report that as many as ½ of all patients with aSBO may be treated without them. A recent meta-analysis showed that hospital length-of-stay (HLOS) may be reduced by 2 days if treated with water-soluble contrast (WSC).

Despite aSBO being common, little is known about the optimal means for its treatment and even less about the mechanisms by which it resolves. The overall intent of this research is to develop evidence-based treatment protocols and to better understand the mechanisms by which aSBO resolves and how interventions can be developed to improve its treatment.

This feasibility study's purpose is to determine the ability to perform a randomized clinical trial (RCT) investigating treatments options for aSBO. Specifically, WSC will be administered to patients with a SBO followed by randomization to undergo formal upper gastrointestinal-small bowel follow through (UGI-SBFT) series vs no radiologic imaging to determine if radiologic examination can be eliminated when treating patients with aSBO. A concurrent observational arm will enroll patients who elect not to have NGTs placed to follow their hospital course. A state-transition model of daily clinical status will be tested to determine its effectiveness as a primary outcome to replace older, traditional outcomes for hospitalized patients such as diet resumption or length of stay.

Conditions

Small Bowel Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imaging

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

Group Type: EXPERIMENTAL

Abdominal Radiography

Intervention Type: DIAGNOSTIC_TEST

Obtain plain film radiographs 3 times after adminstration of WSC

Control

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

Group Type: ACTIVE_COMPARATOR

Abdominal Radiography

Intervention Type: DIAGNOSTIC_TEST

Obtain plain film radiographs 3 times after adminstration of WSC

Interventions

Abdominal Radiography

Obtain plain film radiographs 3 times after adminstration of WSC

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Written informed consent obtained from subject.

Exclusion Criteria

1. Unable to provide consent for the study.

2. Pregnant or breastfeeding.

3. 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.

4. Unstable angina or recent myocardial infarction or stroke within 6 months

5. Patients with peritonitis or who require immediate surgery.

6. Non-adhesive SBO, including.

• Paralytic Ileus
• Incarcerated hernia
• Fecal impaction
• Intra-abdominal malignancy
• Early aSBO within 4 weeks of a prior abdominal operation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Edward Harry Livingston

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward H Livingston, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Central Contacts

Edward H Livingston, MD

Role: CONTACT

elivingston@mednet.ucla.edu

818-461-3321

Other Identifiers

21-6143

Identifier Type: -

Identifier Source: org_study_id