Optimizing Treatment of Adhesive Small Bowel Obstruction

NCT ID: NCT06182319

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-15

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SBO Treatment Without NG Tubes

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Gastrografin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Administration of Saline 2 hours after placement of NGT.

Interventions

Gastrografin

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

Intervention Type: DRUG

Saline

Administration of Saline 2 hours after placement of NGT.

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Edward Harry Livingston

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Stokes

Role: CONTACT

sstokes@mednet.ucla.edu

310-206-7436

Edward H Livingston, MD

Role: CONTACT

310-794-7788

Facility Contacts

Role: primary

310-825-2631

Related Links

http://pubmed.ncbi.nlm.nih.gov/35837888/

The Effect of Hyperosmolar Water-Soluble Contrast for the Management of Adhesive Small Bowel Obstruction: A Systematic Review and Meta-Analysis

http://pubmed.ncbi.nlm.nih.gov/36992798/

Management of small bowel obstruction and systematic review of treatment without nasogastric tube decompression

Other Identifiers

23-001055

Identifier Type: -

Identifier Source: org_study_id