Optimizing Treatment of Adhesive Small Bowel Obstruction

NCT06182319 — Phase 3, Recruiting, 40 participants, University of California, Los Angeles

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

Registry	NCT06182319
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	University of California, Los Angeles (Other)
Conditions	Adhesive Small Bowel Obstruction
Interventions	Gastrografin, Saline, SBO Treatment Without NG Tubes (Drug, procedure)
Dates	start 2024-01-01, primary completion 2025-12-15 (estimated), completion 2025-12-15 (estimated), first posted 2023-12-26, last updated 2024-05-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
SBO treated without NG tube	Experimental	Procedure: SBO Treatment Without NG Tubes	Patients who decline NG intubation will be enrolled in the trial, followed prospectively and have the same outcome measures as are acquired in the other study arms.
SBO treated with NG tube and Water-Soluble Contrast (WSC)	Experimental	Drug: Gastrografin	Patients who select NG tube treatment will be randomized into experimental and control groups. The experimental groups will have 100 cc of WSC administered in the NG tube within 2 hours of NG tube placement.
SBO Treated with NG tube and Placebo	Placebo comparator	Drug: Saline	The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement.

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of California, Los Angeles, David Geffen School of Medicine	Los Angeles, California	United States	Recruiting