NCT06182319 Optimizing Treatment of Adhesive Small Bowel Obstruction
| NCT ID | NCT06182319 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, Los Angeles |
| Condition | Adhesive Small Bowel Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2024-01-01 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06182319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adhesive Small Bowel Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06182319 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06182319 currently recruiting?
Yes, NCT06182319 is actively recruiting participants. Contact the research team at sstokes@mednet.ucla.edu for enrollment information.
Where is the NCT06182319 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06182319 clinical trial?
NCT06182319 is sponsored by University of California, Los Angeles. The trial plans to enroll 40 participants.