Optimizing Treatment of Adhesive Small Bowel Obstruction

Adhesive Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182319
• Other study ID #: 23-001055
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Steven Stokes
• Phone: 310-206-7436
• Email: sstokes[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Small Bowel Obstruction
• Intestinal Obstruction

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Los Angeles, David Geffen School of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS®)-29	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.	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.

External Links

•   Management of small bowel obstruction and systematic review of treatment without nasogastric tube decompression
•   The Effect of Hyperosmolar Water-Soluble Contrast for the Management of Adhesive Small Bowel Obstruction: A Systematic Review and Meta-Analysis