The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial (SBO-TUBE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Small Bowel Obstruction; Intestinal Obstruction and Ileus
• Intervention / Treatment: Procedure: Nasogastric tube placement

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens Wretborn, Associate Professor; Phone Number: +46101030000; Email: jens.wretborn@liu.se
• Study Contact Backup: Name: Erika Johannesson, MSc; Phone Number: +46101030000

Study Locations

• Sweden
  • Linköping, Sweden, 58561
    • Linkoping University Hospital
    • Contact: Jens Wretborn, Associate Professor; Phone Number: +46101030000; Email: jens.wretborn@liu.se
  • Motala, Sweden, 59135
    • Motala Lasarett
    • Contact: Jens Wretborn, Associate Professor; Phone Number: +46101030000; Email: jens.wretborn@liu.se
  • Värnamo, Sweden, 33156
    • Värnamo Lasarett
    • Contact: Jenny Gustavsson, MD; Phone Number: +46102410000; Email: jenny.gustavsson@rjl.se
    • Sub-Investigator: Amanda Tyrsing, MD
    • Sub-Investigator: Kaj Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasogastric Tube; This arm receives a nasogastric tube. Other management according to local guidelines.	Procedure: Nasogastric tube placement; The placement of a nasogastric tube from the nares to gastric ventricle.
No Intervention: No Nasogastric Tube; Nasogastric tube is deferred. Other management according to local guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment until 30 days or hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery	Requiring surgery for their small bowel obstruction	From enrollment until 30 days or hospital discharge, whichever comes first
Death	Death from any cause	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	From enrollment until 30 days or hospital discharge, whichever comes first
Bowel perforation	As a finding, or complication, during surgery	From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection	Bowel resection during surgery measured in cm.	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	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	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	From enrollment until 30 days or hospital discharge, whichever comes first
Readmission for small bowel obstruction	Any readmission to hospital for small bowel obstruction	From enrollment until 365 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Small Bowel Obstruction	Admission for small bowel obstruction	From inclusion until 365 days
Health-related quality of life	Measured by the EQ-5D-5L tool	Up to 30 days after hospital discharge
Number of required morphine-equivalents		From inclusion until 30 days or hospital discharge, whichever comes first
Nausea	Nausea, measured on a numeric rating scale from 0 to 10	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	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	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	From enrollment until 30 days or hospital admission, whichever comes first

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Linkoeping University; Region Jönköping County
• Investigators: Principal Investigator: Jens Wretborn, Associate Professor, Clinical Department of Emergency Medicine in Linköping, Region Östergötland, Linköping, Sweden; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: small bowel obstruction; nasogastric tube; ileus
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Ileus; Intestinal Obstruction
• Other Study ID Numbers: 2026-00330-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No