Adhesive Small Bowel Obstruction
Conditions
Keywords
nasogastric tube (NGT), water-soluble contrast (WSC), Adhesion-related SBO (aSBO), Small bowel obstruction (SBO)
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.
Interventions
DRUGGastrografin
Administration of WSC (Gastrografin) 2 hours after placement of NGT.
DRUGSaline
Administration of Saline 2 hours after placement of NGT.
PROCEDURESBO 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
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 | 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. |
Countries
United States
Contacts
Primary ContactSteven Stokes
Backup ContactEdward H Livingston, MD
Outcome results
None listed