Optimizing Treatment of Adhesive Small Bowel Obstruction

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06182319
Phase
PHASE3
Status
Recruiting
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Conditions

  • Adhesive Small Bowel Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gastrografin — DRUG
    Administration of WSC (Gastrografin) 2 hours after placement of NGT.
  • Saline — DRUG
    Administration of Saline 2 hours after placement of NGT.
  • SBO Treatment Without NG Tubes — PROCEDURE
    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

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
May 2024
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 [ Time Frame: The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles, David Geffen School of MedicineLos AngelesCalifornia90024
310-825-2631

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By research site
University of California, Los Angeles, David Geffen School of Medicine· Los Angeles, CA

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