Optimizing Treatment of Adhesive Small Bowel Obstruction

Study Overview
=================
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.

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

Conditions
-----------------
Adhesive Small Bowel Obstruction

Intervention / Treatment
-----------------
* Drug: Gastrografin
* Drug: Saline
* Procedure: SBO Treatment Without NG Tubes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age. 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: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 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. Unstable angina or recent myocardial infarction (MI)/stroke within 6 months Nonadhesive SBO Paralytic Ileus Incarcerated hernia Fecal impaction Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBO treated without NG tube<br>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. | Procedure: SBO Treatment Without NG Tubes<br>* 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<br>|
| Experimental: SBO treated with NG tube and Water-Soluble Contrast (WSC)<br>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. | Drug: Gastrografin<br>* Administration of WSC (Gastrografin) 2 hours after placement of NGT.<br>|
| Placebo Comparator: SBO Treated with NG tube and Placebo<br>The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement. | Drug: Saline<br>* Administration of Saline 2 hours after placement of NGT.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 | 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. | The measure will be obtained at baseline before surgery, postoperative period, postoperative follow up clinic visits, postoperative follow up calls, and end of study visit (30 days after surgery). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasogastric tube (NGT), water-soluble contrast (WSC), Adhesion-related SBO (aSBO), Small bowel obstruction (SBO)