Optimizing Treatment of Adhesive Small Bowel Obstruction

NCT06182319 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 23-001055
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

nasogastric tube (NGT); water-soluble contrast (WSC); Adhesion-related SBO (aSBO); Small bowel obstruction (SBO)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

SBO treated without NG tube

EXPERIMENTAL

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.

Procedure: SBO Treatment Without NG Tubes

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

EXPERIMENTAL

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.

Drug: Gastrografin

SBO Treated with NG tube and Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Gastrografin DRUG

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

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

Saline DRUG

Administration of Saline 2 hours after placement of NGT.

SBO Treated with NG tube and Placebo

SBO Treatment Without NG Tubes 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 without NG tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age.
• 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

You may not qualify if:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• 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.
• Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
• Nonadhesive SBO
• Paralytic Ileus
• Incarcerated hernia
• Fecal impaction
• Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

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

Los Angeles, California, 90024, United States

RECRUITING

Related Links

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

MeSH Terms

Interventions

Diatrizoate Meglumine; Sodium Chloride; Enteral Nutrition

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Diatrizoate; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hexosamines; Amino Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

Steven Stokes

CONTACT

310-206-7436; sstokes@mednet.ucla.edu

Edward H Livingston, MD

CONTACT

310-794-7788

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Patients will be allocated into 3 groups: One treated without NG tubes. The other 2 groups will have an NG tube and be randomized into treatment with water-soluble contrast or saline.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)