Small Bowel ObstructionSBO-TUBENCT07574515
The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial
A study testing Nasogastric tube placement in people with Small Bowel Obstruction and Intestinal Obstruction and Ileus, run by University Hospital, Linkoeping at 3 sites in Sweden.
Trial summary
Background: Small bowel obstruction (SBO) is a surgical emergency where the normal continuous bowel movements are hindered and approximately 8000-9000 patients visit the emergency department every year in Sweden due to SBO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction, Intestinal Obstruction and Ileus
- What is being tested?
- Nasogastric tube placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesSweden
- Study dates
- 27 May 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Small bowel obstruction diagnosed on Computer Tomography
Who cannot join
- Nasogastric Tube already places
- Amyotrophic lateral sclerosis
- Cerebral palsy
- Dementia
- Parkinson's disease
- Multiple Sclerosis
Show all 12Show fewer
- Previous stroke with documented persistent dysphagia
- Planned for urgent surgery
- Acute Massive Gastric Dilatation
- Gastric outlet obstruction
- Fundoplicatio/Inability to vomit
- Signs of pneumonia/pneumonitis on initial diagnostic CT
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erika Johannesson, MSc contact
Sweden3 sites, 3 recruiting
- Recruiting
Linköping University Hospital
Linköping, 58561
Jens Wretborn, Associate Professor, +46101030000, jens.wretborn@liu.se
- Recruiting
Motala Lasarett
Motala, 59135
Jens Wretborn, Associate Professor, +46101030000, jens.wretborn@liu.se
- Recruiting
Värnamo Lasarett
Värnamo, 33156
Jenny Gustavsson, MD, +46102410000, jenny.gustavsson@rjl.se
Amanda Tyrsing, MD
About this study
Official title: The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Randomized Controlled Trial
Background: Small bowel obstruction (SBO) is a surgical emergency where the normal continuous bowel movements are hindered and approximately 8000-9000 patients visit the emergency department every year in Sweden due to SBO. A minority of these have evidence of intestinal injury, warranting emergency surgery, while the majority (70-90%) will have an initial plan for non-operative management with a nasogastric tube (NGT), placed to alleviate gastric pressure, reduce pain and prevent complications like aspiration pneumonia. The effectiveness of NGT in patients with SBO to prevent complications is unclear, with current data from observational data indicating increased risk of pneumonia in patients treated with NGT. Objective: To assess whether deferring the placement of a NGT in subjects with small bowel obstruction and planned for non-operative management leads to lower rates of respiratory complication compared to placing an NGT. Methods: This will be a randomized, controlled, open-label, multicenter study of patients with SBO and an initial plan for non-operative management. Patients will be randomized in a 1:1 ratio to not receive an NGT (intervention) or receive an NGT (control) and monitored regularly until the SBO resolves spontaneously or through surgery, whichever comes first. The primary outcome will be a composite of pulmonary complications and treatment in a high dependency unit, analyzed as a superiority study with an intention-to-treat framework with secondary per-protocol and non-inferiority analysis. The trial will recruit 1000 patients. Secondary analysis includes health-economy, qualitative interviews, and long term (1 year) follow up. Discussion: The current management of NGT in SBO is based on clinical and guideline-based recommendations with limited supporting data. Available data, albeit observational with risk for selection bias, indicates increased risk of complications. This equipoise warrants further investigation to understand the true benefit of NGT in SBO. This study will provide high quality evidence of the ability of a NGT to prevent complications in SBO through its randomized, prospective design
- Being tested
- Nasogastric tube placement
- Keywords
- ileus, small bowel obstruction, nasogastric tube
- Medical subject headings
- Intestinal Obstruction, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric tube placementProcedure or surgery
The placement of a nasogastric tube from the nares to gastric ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric Tube | Experimental | This arm receives a nasogastric tube. Other management according to local guidelines. Receives: Procedure: Nasogastric tube placement |
| No Nasogastric Tube | No intervention | Nasogastric tube is deferred. Other management according to local guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
Pulmonary complications, any of:
- Respiratory infection - treatment with antibiotics supported by suggestive findings on x-ray and/or laboratory findings
- Respiratory failure - new pulse-oximetry values below 90% or an increased need for supplemental oxygen for an oxygen saturation above 90%, measured by pulse-oximetry or blood gases.
- Pleural effusion - based on x-ray findings
- Atelectasis - based on x-ray findings
- Pneumothorax - based on x-ray findings
- Bronchospasm - documented wheezing or increased effort breathing
- Aspiration pneumonitis - treatment with antibiotics supported by suggestive findings on x-ray and/or laboratory findings and a clinical correlation to an event of vomiting/dysphagia High dependency unit or Intensive care unit
This study will use the definitions of pulmonary complications defined by Jammer et al:
Individual components of the composite endpoint will be reported and analysed separately as secondary endpoints.
Measured: From enrollment until 30 days or hospital discharge
Secondary outcomes (9)
Surgery
Requiring surgery for their small bowel obstruction
Measured: From enrollment until 30 days or hospital discharge, whichever comes first
Death
Death from any cause
Measured: From enrollment until 365 days
Time to functional recovery
Time to functional recovery is seen as a more objective outcome compared to hospital length of stay, which may be influenced by other factors, not related to the disease. Functional recovery is a composite of the following components:
- Independently mobile at preoperative level
- Sufficient pain control with oral medications only
- Ability to maintain necessary caloric intake with parenteral nutrition of fluids
- No intravenous fluid administration
- No clinical signs of infection
Measured: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel perforation
As a finding, or complication, during surgery
Measured: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection
Bowel resection during surgery measured in cm.
Measured: From enrollment until 30 days or hospital discharge, whichever comes first
Hospital Length of Stay
Length of stay in hospitals measured both as when the subject is ready to leave the hospital and when the subject actually leaves hospital
Measured: Enrollment until 30 days or hospital discharge, whichever comes first
Emergency Department Length of Stay
The duration the research subject stays in the Emergency Department
Measured: From emergency department registration until 2 days or emergency department discharge, whichever comes first.
Time to resolved small bowel obstruction
Time to resolvement of obstruction, defined as either; Water soluable contrast passing to the colon, or both ability to pass gas and ability for oral intake
Measured: From enrollment until 30 days or hospital discharge, whichever comes first
Readmission for small bowel obstruction
Any readmission to hospital for small bowel obstruction
Measured: From enrollment until 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start27 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Region Jönköping County
- Responsible party
- Principal investigator, Daniel Wilhelms, University Hospital, Linkoeping
- Investigators
- Jens Wretborn, Associate Professor, Principal investigator, Clinical Department of Emergency Medicine in Linköping, Region Östergötland, Linköping, Sweden; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574515
- Sponsor's protocol ID
- 2026-00330-01
- Acronym
- SBO-TUBE
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07574515
- Acronym / sponsor ID
- SBO-TUBE / 2026-00330-01
- Keywords
- ileus, small bowel obstruction, nasogastric tube
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University, Region Jönköping County
- Study start
- 27 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Small bowel obstruction (SBO) is a surgical emergency where the normal continuous bowel movements are hindered and approximately 8000-9000 patients visit the emergency department every year in Sweden due to SBO. A minority of these have evidence of intestinal injury, warranting emergency surgery, while the majority (70-90%) will have an initial plan for non-operative management with a nasogastric tube (NGT), placed to alleviate gastric pressure, reduce pain and prevent complications like aspiration pneumonia. The effectiveness of NGT in patients with SBO to prevent complications is unclear, with current data from observational data indicating increased risk of pneumonia in patients treated with NGT. Objective: To assess whether deferring the placement of a NGT in subjects with small bowel obstruction and planned for non-operative management leads to lower rates of respiratory complication compared to placing an NGT. Methods: This will be a randomized, controlled, open-label, multicenter study of patients with SBO and an initial plan for non-operative management. Patients will be randomized in a 1:1 ratio to not receive an NGT (intervention) or receive an NGT (control) and monitored regularly until the SBO resolves spontaneously or through surgery, whichever comes first. The primary outcome will be a composite of pulmonary complications and treatment in a high dependency unit, analyzed as a superiority study with an intention-to-treat framework with secondary per-protocol and non-inferiority analysis. The trial will recruit 1000 patients. Secondary analysis includes health-economy, qualitative interviews, and long term (1 year) follow up. Discussion: The current management of NGT in SBO is based on clinical and guideline-based recommendations with limited supporting data. Available data, albeit observational with risk for selection bias, indicates increased risk of complications. This equipoise warrants further investigation to understand the true benefit of NGT in SBO. This study will provide high quality evidence of the ability of a NGT to prevent complications in SBO through its randomized, prospective design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasogastric Tube | Experimental | Procedure: Nasogastric tube placementThis arm receives a nasogastric tube. Other management according to local guidelines. |
| No Nasogastric Tube | No intervention | –Nasogastric tube is deferred. Other management according to local guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Small bowel obstruction diagnosed on Computer Tomography
Key exclusion criteria (12 listed)
- Nasogastric Tube already places
- Amyotrophic lateral sclerosis
- Cerebral palsy
- Dementia
- Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastric tube placementThe placement of a nasogastric tube from the nares to gastric ventricle. | Procedure or surgery | Nasogastric Tube |
Primary outcome
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
Time frame: From enrollment until 30 days or hospital discharge
Pulmonary complications, any of: * Respiratory infection - treatment with antibiotics supported by suggestive findings on x-ray and/or laboratory findings * Respiratory failure - new pulse-oximetry values below 90% or an increased need for supplemental oxygen for an oxygen saturation above 90%, measured by pulse-oximetry or blood gases. * Pleural effusion - based on x-ray findings * Atelectasis - based on x-ray findings * Pneumothorax - based on x-ray findings * Bronchospasm - documented wheezing or increased effort breathing * Aspiration pneumonitis - treatment with antibiotics supported by suggestive findings on x-ray and/or laboratory findings and a clinical correlation to an event of vomiting/dysphagia High dependency unit or Intensive care unit This study will use the definitions of pulmonary complications defined by Jammer et al: Individual components of the composite endpoint will be reported and analysed separately as secondary endpoints.
9 secondary outcomes
Surgery
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Death
Time frame: From enrollment until 365 days
Time to functional recovery
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel perforation
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Hospital Length of Stay
Time frame: Enrollment until 30 days or hospital discharge, whichever comes first
Emergency Department Length of Stay
Time frame: From emergency department registration until 2 days or emergency department discharge, whichever comes first.
Time to resolved small bowel obstruction
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Readmission for small bowel obstruction
Time frame: From enrollment until 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika Johannesson, MSc contact
Jens Wretborn, Associate Professor principal investigator
Clinical Department of Emergency Medicine in Linköping, Region Östergötland, Linköping, Sweden; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastric tube placement in people with Small Bowel Obstruction and Intestinal Obstruction and Ileus, run by University Hospital, Linkoeping at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Wretborn, Associate Professor (+46101030000, jens.wretborn@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit (time frame: From enrollment until 30 days or hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.