The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nasogastric tube placement.
- Who it may be relevant to
- Registry conditions: Small Bowel Obstruction, Intestinal Obstruction and Ileus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Randomized Controlled Trial
Overview
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
Interventions
- Procedure Nasogastric tube placement
The placement of a nasogastric tube from the nares to gastric ventricle.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- Small bowel obstruction diagnosed on Computer Tomography
Exclusion criteria
- Nasogastric Tube already places
- Amyotrophic lateral sclerosis
- Cerebral palsy
- Dementia
- Parkinson's disease
- Multiple Sclerosis
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 3 centers
- Linköping University Hospital — Linköping
- Motala Lasarett — Motala
- Värnamo Lasarett — Värnamo
Identifiers
NCT: NCT07574515 · 2026-00330-01