NCT06182319

Optimizing Treatment of Adhesive Small Bowel Obstruction

The Use of Nasogastric Tubes And Water-Soluble Contrast In The Management Of Small Bowel Obstruction: A Feasibility Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Gastrografin	Administration of WSC (Gastrografin) 2 hours after placement of NGT.
DRUG	Saline	Administration of Saline 2 hours after placement of NGT.
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

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2023-12-26
• Last updated: 2024-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study