Recruiting
Phase 3

Adhesive Small Bowel Obstruction

Sponsor:

UCLA

Code:

NCT06182319

Conditions

Adhesive Small Bowel Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gastrografin

Saline

SBO Treatment Without NG Tubes

Study Details

Brief summary:

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.

Conditions

Adhesive Small Bowel Obstruction

Study ID

NCT06182319

Start date

Jan 1, 2024

Status verified date

May, 2024

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Gastrografin

Administration of WSC (Gastrografin) 2 hours after placement of NGT.

Saline

Administration of Saline 2 hours after placement of NGT.

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

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 and Locations

Central contacts

Steven Stokes

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

Edward H Livingston, MD

310-794-7788

Locations

University of California, Los Angeles, David Geffen School of Medicine

Recruiting

Los Angeles, California, United States, 90024

Contacts

310-825-2631

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 8, 2024

Last verified

May, 2024

Keywords

  • nasogastric tube (NGT)
  • water-soluble contrast (WSC)
  • Adhesion-related SBO (aSBO)
  • Small bowel obstruction (SBO)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2024-05-08.