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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to treat adhesion-related small bowel obstruction (aSBO), a serious digestive condition where the small intestine is blocked. The study will explore whether patients can recover without using a nasogastric tube (a tube through the nose into the stomach) by comparing different treatments, including SBO Treatment Without NG Tubes. Patients with symptoms such as nausea, vomiting, or abdominal pain, and who have been diagnosed with aSBO, might be suitable for this study. Participants will help researchers learn which treatments improve quality of life and determine when it's safe for patients to resume eating and leave the hospital. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many people with small bowel obstruction (SBO) can be safely treated without a nasogastric tube (NGT). One study revealed that 36% of 759 patients were successfully managed without NGTs. Another study found that 80% of cases responded well to simple methods like observation and fluids, which are less invasive. These methods also led to fewer short-term issues compared to early surgeries.

Overall, treating SBO without NGTs appears safe and well-tolerated. Most patients recover without needing more invasive procedures, experiencing fewer short-term complications. This approach offers a promising option for those wishing to avoid the discomfort of an NGT. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores new approaches to treating small bowel obstruction (SBO) that could reduce patient discomfort and improve outcomes. Traditionally, SBO is often managed with nasogastric (NG) tube insertion to relieve pressure and prevent vomiting. However, this trial is investigating the possibility of treating SBO without the use of NG tubes, potentially offering a more comfortable experience for patients. Additionally, for those who do use NG tubes, the trial examines the potential benefits of adding Water-Soluble Contrast (WSC) to speed up the resolution of the obstruction compared to using just a placebo. These innovations could lead to faster recovery times and less invasive treatment options for individuals suffering from SBO.

What evidence suggests that this trial's treatments could be effective for small bowel obstruction?

Research has shown that treating small bowel obstruction (SBO) without nasogastric tubes (NGTs) can be very effective. In this trial, one arm will examine SBO treatment without NGTs, which studies indicate works in over 70% of cases for managing adhesive SBO without surgery. This method results in fewer short-term complications and deaths compared to early surgery. Additionally, avoiding NGTs can shorten hospital stays and reduce health issues, especially if no abdominal infection is present. Overall, many patients can recover well without needing an NGT. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10040372/

Management of small bowel obstruction and systematic ... There were 3 articles of the initial 1650 screened that reported outcomes of SBO treatment without NGTs. These articles included 759 patients, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12540683/

Success rate and associated factors of conservative ... Conservative management of ASBO is advantageous for reducing morbidity, mortality, and hospital stays, especially in cases without peritonitis, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961018303441

Non-operative management of adhesive small bowel ... The management of adhesive SBO remains a largely nonoperative practice, with 40% to 70% of cases successfully treated nonoperatively.13–16 This is not indicated ...

4. academic.oup.com academic.oup.com/bjs/article/doi/10.1093/bjs/znaf104/8172364

SBO ACTION: conservative Small Bowel Obstruction ... Non-operative management (NOM) for aSBO can be successful in over 70% of patients, with lower rates of short-term morbidity and mortality compared to early ...

5. emedicine.medscape.com emedicine.medscape.com/article/774140-treatment

Small-Bowel Obstruction Treatment & Management Good data regarding nonoperative management suggest it to be successful in 65-81% of partial SBO cases without peritonitis. Nonoperative ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X2308705X

Conservative Management of Adhesive Small Bowel ... Of the 130 cases, 104 cases (80%) were successfully treated by conservative management, and the symptoms of SBO were resolved by the sixth day (range 1 to 22).

7. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-018-0185-2

Bologna guidelines for diagnosis and management of ... The present paper presents a revised version of the Bologna guidelines to evidence-based diagnosis and treatment of ASBO.

8. nature.com nature.com/articles/s41598-025-20288-z

Success rate and associated factors of conservative ... Studies indicate that 70% to 80% of adhesive small bowel obstruction (ASBO) cases can be effectively managed through conservative treatment.