Optimizing Treatment of Adhesive Small Bowel Obstruction

Phase 3

Recruiting

• Conditions: Adhesive Small Bowel Obstruction
• Interventions: Procedure: SBO Treatment Without NG Tubes; Drug: Saline; Drug: Gastrografin

• Registration Number: NCT06182319
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2023-12-26
• Study Start: 2024-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBO treated without NG tube	SBO Treatment Without NG Tubes	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.
SBO Treated with NG tube and Placebo	Saline	The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement.
SBO treated with NG tube and Water-Soluble Contrast (WSC)	Gastrografin	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.

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS®)-29	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.	Quality of life will be assessed using the PROMIS-29 HRQOL instrument. The survey uses multiple response formats. A total score provides an index of HRQOL, with higher scores on a scale of 0-100 reflecting better HRQOL.

Trial Locations

Locations (1)

University of California, Los Angeles, David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States