Optimizing Treatment for Small Bowel Obstruction

Overseen By Edward H Livingston, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, Los Angeles

Disqualifiers: Pregnancy, Unstable angina, Recent MI/stroke, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 30 days

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment for small bowel obstruction without using NG tubes?

Research shows that non-surgical management of adhesive small bowel obstruction (ASBO) often leads to resolution for most patients, indicating that conservative treatment can be effective. However, it is important to note that while non-operative management is successful for many, some patients may still require surgery. ^{1 2 3 4 5}

Is non-surgical treatment for small bowel obstruction safe?

Non-surgical treatment for small bowel obstruction is generally safe for most patients, as it often leads to resolution without surgery. However, there is a risk of recurrence, and some patients may eventually require surgery if non-surgical methods are not effective. ^{1 2 3 4 6}

How is the SBO Treatment Without NG Tubes different from other treatments for small bowel obstruction?

This treatment is unique because it focuses on managing small bowel obstruction without using nasogastric tubes, which are typically used to decompress the stomach in traditional non-surgical management. Instead, it relies on other conservative methods, potentially reducing discomfort and complications associated with tube insertion. ^{1 2 3 7 8}

Eligibility Criteria

This trial is for individuals with adhesive small bowel obstruction (aSBO). Participants must have a confirmed diagnosis of aSBO and be suitable candidates for the study as determined by their healthcare providers. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have symptoms like nausea, vomiting, abdominal pain, or a swollen belly, and a CT scan shows I have a small bowel obstruction.

Exclusion Criteria

I have a hernia that is trapped and cannot be pushed back in.

I had abdominal surgery and developed a blockage within 4 weeks.

I am currently experiencing severe constipation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive treatment for aSBO with or without NG tube and WSC, including administration of IV fluids and observation by a surgical team

Up to 30 days

Daily hospital visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with HRQOL measured at multiple time points

30 days

1 visit (in-person) at 30 days post-discharge

Treatment Details

Interventions

• SBO Treatment Without NG Tubes

Trial Overview The study is testing if patients with aSBO can be treated without nasogastric tubes (NGTs) using saline or gastrografin, which are types of treatments. It will also assess quality of life outcomes and develop treatment protocols based on whether NGTs are used.

Participant Groups

Group I: SBO treated without NG tube Experimental Treatment 1 Intervention

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.

Group II: SBO treated with NG tube and Water-Soluble Contrast (WSC) Experimental Treatment 1 Intervention

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.

Group III: SBO Treated with NG tube and Placebo Placebo Group 1 Intervention

The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement.

SBO Treatment Without NG Tubes is already approved in United States, European Union for the following indications:

Approved in United States as Conservative Management of aSBO for:

• Adhesive Small Bowel Obstruction

Approved in European Union as Non-Surgical Management of aSBO for:

• Adhesive Small Bowel Obstruction

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

After implementing a resident-run emergency general surgery service, 74% of patients with adhesive small bowel obstruction (ASBO) were admitted to a surgical service, a significant increase from 35% before the residency program.

Patients treated under the new residency program experienced a 0.77-day reduction in hospital stay, a 24% decrease in average treatment costs, and a 35.7% reduction in 30-day readmissions, with no change in mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General Surgery Residency and Emergency General Surgery Service Reduces Readmission Rates and Length of Stay in Nonoperative Small Bowel Obstruction. Manning, SW., Orr, SL., Mastriani, KS.[2020]

In a study of 252 patients with adhesive small bowel obstruction (SBO), certain imaging findings, such as a definitive transition point and free fluid, were identified as predictors for the need for surgical intervention, helping to guide treatment decisions.

The presence of contrast in the colon after administering water-soluble contrast medium was found to be a strong indicator (3.83 times more likely) of successful non-operative management, suggesting that imaging can significantly influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors for success of non-operative management of adhesive small bowel obstruction. Ng, ZQ., Hsu, V., Tee, WWH., et al.[2023]

In a study of 234 patients with postoperative adhesive small bowel obstruction (ASBO), it was found that early placement of a long tube for conservative treatment is crucial, as a significant difference in symptom onset to tube insertion time was observed (35 hours vs. 44 hours).

The volume of drainage through the long tube on day 3 was a key indicator for deciding whether to proceed with surgery, with a cut-off value of 500mL distinguishing between those who improved conservatively and those who required surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The indicator for surgery in adhesive small bowel obstruction patient managed with long tube. Sakakibara, T., Harada, A., Yaguchi, T., et al.[2022]

In a study of 25,150 patients with adhesive small bowel obstruction (aSBO), early operative management (EOM) resulted in a significantly lower recurrence rate (13.2%) compared to trial of non-operative management (TNOM) which had a recurrence rate of 20.9%.

Although EOM had higher upfront costs ($17,951 vs. $11,594 for TNOM), it was found to be cost-effective with an incremental cost-effectiveness ratio (ICER) of $29,881 per quality-adjusted life-year (QALY), suggesting that EOM may provide better long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early operative management in patients with adhesive small bowel obstruction: population-based cost analysis. Behman, R., Nathens, AB., Pechlivanoglou, P., et al.[2021]

Minimally invasive surgical techniques and the use of adhesion barriers can help reduce the formation of adhesions that lead to adhesive small bowel obstruction (ASBO), which is a common surgical emergency.

Non-operative treatment is effective for most ASBO patients, but certain conditions like peritonitis or strangulation require surgical intervention, with a laparoscopic approach being beneficial in selected cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2017 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. Ten Broek, RPG., Krielen, P., Di Saverio, S., et al.[2018]

In a study of 8 children with uncomplicated adhesive small bowel obstruction (SBO), the use of Gastrografin significantly reduced the length of hospital stay and the time to first feeding compared to matched controls.

The results suggest that Gastrografin could be an effective conservative treatment option for managing SBO in children, potentially avoiding the need for more invasive surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrografin for uncomplicated adhesive small bowel obstruction in children. Bonnard, A., Kohaut, J., Sieurin, A., et al.[2021]

This study will evaluate the efficacy of laser acupuncture in treating adhesive small bowel obstruction (ASBO) in 92 participants through a randomized controlled trial, focusing on the success rate of conservative treatment.

Participants will receive either real or sham laser acupuncture for 6 days, with outcomes measured including time to oral intake and length of hospital stay, alongside various serum biomarkers to assess treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of laser acupuncture on adhesive small bowel obstruction: A prospective double-blind randomized controlled trial. Shih, CH., Hsieh, TM., Wu, BY., et al.[2023]

A new protocol using a water-soluble contrast agent for managing adhesive small bowel obstruction (ASBO) significantly reduced the average length of hospital stay from 6.56 days to 4.08 days for patients, based on a study of 767 patients from 2010 to 2018.

The protocol also decreased the time from admission to surgery from 3.79 days to 2.10 days, which may help lower the rates of bowel ischemia and the need for surgical resections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Protocol Utilizing Water-Soluble Contrast for Adhesive Small Bowel Obstruction. Dombert, L., Hussain, A., Bullock, B., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

General Surgery Residency and Emergency General Surgery Service Reduces Readmission Rates and Length of Stay in Nonoperative Small Bowel Obstruction. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Predictors for success of non-operative management of adhesive small bowel obstruction. [2023]

3. Greece pubmed.ncbi.nlm.nih.gov

The indicator for surgery in adhesive small bowel obstruction patient managed with long tube. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Early operative management in patients with adhesive small bowel obstruction: population-based cost analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2017 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Gastrografin for uncomplicated adhesive small bowel obstruction in children. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of laser acupuncture on adhesive small bowel obstruction: A prospective double-blind randomized controlled trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of Protocol Utilizing Water-Soluble Contrast for Adhesive Small Bowel Obstruction. [2021]