Optimizing Treatment of Adhesive Small Bowel Obstruction

a study on Adhesive Small Bowel Obstruction

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Edward Harry Livingston (ucla)

Description

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.

Official Title

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

Keywords

Adhesive Small Bowel Obstruction, nasogastric tube (NGT), water-soluble contrast (WSC), Adhesion-related SBO (aSBO), Small bowel obstruction (SBO), Intestinal Obstruction, Gastrografin, Saline, SBO Treatment Without NG Tubes

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Location

  • University of California, Los Angeles, David Geffen School of Medicine accepting new patients
    Los Angeles California 90024 United States

Lead Scientist at University of California Health

  • Edward Harry Livingston (ucla)
    HS Clinical Professor, Surgery, Medicine. Authored (or co-authored) 299 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
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
ID
NCT06182319
Phase
Phase 3 Adhesive Small Bowel Obstruction Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated