Optimizing Treatment of Adhesive Small Bowel Obstruction

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 3

Conditions: Adhesive Small Bowel Obstruction

Treatments: Drug: Gastrografin; Drug: Saline; Procedure: SBO Treatment Without NG Tubes

Study type: Interventional

Funder types: Other

Identifiers

NCT06182319

23-001055

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups, including a placebo group

SBO treated without NG tube

Experimental group

Description:

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.

Treatment:

Procedure: SBO Treatment Without NG Tubes

SBO treated with NG tube and Water-Soluble Contrast (WSC)

Experimental group

Description:

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.

Treatment:

Drug: Gastrografin

SBO Treated with NG tube and Placebo

Placebo Comparator group

Description:

The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement.

Treatment:

Drug: Saline