An interventional study of Nasogastric tube placement in Small Bowel Obstruction and Intestinal Obstruction and Ileus, sponsored by University Hospital, Linkoeping. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Treatment
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
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →University Hospital, Linkoeping is the lead sponsor of 119 studies on the registry; 15 are open to participants now.
Compared within Ileus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Intestinal Obstruction. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm receives a nasogastric tube. Other management according to local guidelines.
Procedure: Nasogastric tube placement
Nasogastric tube is deferred. Other management according to local guidelines
The 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.
Time frame: From enrollment until 30 days or hospital discharge
Surgery
Requiring surgery for their small bowel obstruction
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Death
Death from any cause
Time frame: 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
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel perforation
As a finding, or complication, during surgery
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection
Bowel resection during surgery measured in cm.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment until 30 days or hospital discharge, whichever comes first
Readmission for small bowel obstruction
Any readmission to hospital for small bowel obstruction
Time frame: From enrollment until 365 days
Recurrent Small Bowel Obstruction
Admission for small bowel obstruction
Time frame: From inclusion until 365 days
Health-related quality of life
Measured by the EQ-5D-5L tool
Time frame: Up to 30 days after hospital discharge
Number of required morphine-equivalents
Time frame: From inclusion until 30 days or hospital discharge, whichever comes first
Nausea
Nausea, measured on a numeric rating scale from 0 to 10
Time frame: From enrollment until 30 days or hospital admission, whichever comes first
Pain from Small bowel obstruction
Pain, measure on a numeric rating scale from 0-10
Time frame: From enrollment until 30 days or hospital admission, whichever comes first
Pain from insertion of nasogastric tube
Patient experience pain on a NRS 0-10 scale
Time frame: From enrollment until 2 days or emergency department discharge, whichever comes first
Discomfort from nasogastric tube
Patient-experience discomfort, rated on NRS (0-10) scale
Time frame: From enrollment until 30 days or hospital admission, whichever comes first
Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.
Of 40 non-industry interventional studies with no phase under Ileus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's planned 19 months is close to that.
Counting every sponsor, half of 40 studies reached it within 19 months; a quarter within 7 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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