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

NCT07574515 | Not Yet Recruiting DMC

• 1 other identifier: 2026-00330-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief 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. 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. We plan to 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

Conditions

Small Bowel Obstruction; Intestinal Obstruction and Ileus

Keywords

ileus; small bowel obstruction; nasogastric tube

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Surgery

  From enrollment until 30 days or hospital discharge, whichever comes first

• Death

  From enrollment until 365 days

• Time to functional recovery

  From enrollment until 30 days or hospital discharge, whichever comes first

• Bowel perforation

  From enrollment until 30 days or hospital discharge, whichever comes first

• Bowel resection

  From enrollment until 30 days or hospital discharge, whichever comes first

Other Outcomes (7)

• Recurrent Small Bowel Obstruction

  From inclusion until 365 days

• Health-related quality of life

  Up to 30 days after hospital discharge

• Number of required morphine-equivalents

  From inclusion until 30 days or hospital discharge, whichever comes first

Study Arms (2)

Nasogastric Tube

EXPERIMENTAL

This arm receives a nasogastric tube. Other management according to local guidelines.

Procedure: Nasogastric tube placement

No Nasogastric Tube

NO INTERVENTION

Nasogastric tube is deferred. Other management according to local guidelines

Interventions

Nasogastric tube placement PROCEDURE

The placement of a nasogastric tube from the nares to gastric ventricle.

Nasogastric Tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Small bowel obstruction diagnosed on Computer Tomography

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Linkoeping University: collaborator
• Region Jönköping County: collaborator

Study Sites (3)

Linköping University Hospital

Linköping, 58561, Sweden

Location

Motala Lasarett

Motala, 59135, Sweden

Location

Värnamo Lasarett

Värnamo, 33156, Sweden

Location

MeSH Terms

Conditions

Intestinal Obstruction; Ileus

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Wretborn, Associate Professor

CONTACT

+46101030000; jens.wretborn@liu.se

Erika Johannesson, MSc

CONTACT

+46101030000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 8, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

SE (3)