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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female ≥18 years of age. 2. 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

Exclusion Criteria

  1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. 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. 3. Unstable angina or recent myocardial infarction (MI)/stroke within 6 months 4. Nonadhesive SBO 1. Paralytic Ileus 2. Incarcerated hernia 3. Fecal impaction 4. Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Patients will be allocated into 3 groups: One treated without NG tubes. The other 2 groups will have an NG tube and be randomized into treatment with water-soluble contrast or saline.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SBO treated without NG tube 		Patients who decline NG intubation will be enrolled in the trial, followed prospectively and have the same outcome measures as are acquired in the other study arms.
  • Procedure: SBO Treatment Without NG Tubes
    Patients who decline to have NG tubes placed will be enrolled and followed with the same outcomes protocol as the other patients in the trial
Experimental
SBO treated with NG tube and Water-Soluble Contrast (WSC) 		Patients who select NG tube treatment will be randomized into experimental and control groups. The experimental groups will have 100 cc of WSC administered in the NG tube within 2 hours of NG tube placement.
  • Drug: Gastrografin
    Administration of WSC (Gastrografin) 2 hours after placement of NGT.
Placebo Comparator
SBO Treated with NG tube and Placebo 		The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement.
  • Drug: Saline
    Administration of Saline 2 hours after placement of NGT.

Recruiting Locations

University of California, Los Angeles, David Geffen School of Medicine
Los Angeles, California 90024
Contact:
310-825-2631

More Details

Status
Recruiting
Sponsor
University of California, Los Angeles

Study Contact

Steven Stokes
310-206-7436
sstokes@mednet.ucla.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.