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NCT Number: NCT06182319

Optimizing Treatment of Adhesive Small Bowel Obstruction

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.

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Key information

Conditions

Adhesive Small Bowel Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Los Angeles, California, 90024, United States

Location status: Recruiting

Location contact

CONTACT

310-825-2631

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Gastrografin

Drug

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

Saline

Drug

Administration of Saline 2 hours after placement of NGT.

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

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS®)-29

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edward H Livingston, MD

CONTACT

310-794-7788

Steven Stokes

CONTACT

[email protected]

310-206-7436

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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