Clinical trial NCT06182319: Optimizing Treatment of Adhesive Small Bowel Obstruction
Official title: The Use of Nasogastric Tubes And Water-Soluble Contrast In The Management Of Small Bowel Obstruction: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Adhesive Small Bowel Obstruction
Keywords: nasogastric tube (NGT)
water-soluble contrast (WSC)
Adhesion-related SBO (aSBO)
Small bowel obstruction (SBO)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS®)-29
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles, David Geffen School of Medicine
state: California
Study officials:
References: