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
Small bowel obstruction diagnosed on Computer Tomography
Nasogastric Tube already places
Amyotrophic lateral sclerosis
Cerebral palsy
Dementia
Parallel
Nasogastric tube placement
Procedure/SurgeryThe placement of a nasogastric tube from the nares to gastric ventricle.
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.
Surgery
Requiring surgery for their small bowel obstruction
Death
Death from any cause
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
Bowel perforation
As a finding, or complication, during surgery
Recurrent Small Bowel Obstruction
Admission for small bowel obstruction
Health-related quality of life
Measured by the EQ-5D-5L tool
Number of required morphine-equivalents
Nausea
Nausea, measured on a numeric rating scale from 0 to 10
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University Hospital, Linkoeping
Lead sponsor
Linkoeping University
Collaborator
Region Jönköping County
Collaborator
