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NCT Number: NCT07574515

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

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Key information

Conditions

Small Bowel Obstruction Digestive System Diseases Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction Intestinal Obstruction and Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University Hospital, Linköping, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasogastric tube placement

Procedure

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Surgery

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

    Requiring surgery for their small bowel obstruction

  2. Death

    Time frame: From enrollment until 365 days

    Death from any cause

  3. Time to functional recovery

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

    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

  4. Bowel perforation

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

    As a finding, or complication, during surgery

  5. Bowel resection

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

    Bowel resection during surgery measured in cm.

  6. Hospital Length of Stay

    Time frame: Enrollment until 30 days or hospital discharge, whichever comes first

    Length of stay in hospitals measured both as when the subject is ready to leave the hospital and when the subject actually leaves hospital

  7. Emergency Department Length of Stay

    Time frame: From emergency department registration until 2 days or emergency department discharge, whichever comes first.

    The duration the research subject stays in the Emergency Department

  8. Time to resolved small bowel obstruction

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

    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

  9. Readmission for small bowel obstruction

    Time frame: From enrollment until 365 days

    Any readmission to hospital for small bowel obstruction

Other outcomes

  1. Recurrent Small Bowel Obstruction

    Time frame: From inclusion until 365 days

    Admission for small bowel obstruction

  2. Health-related quality of life

    Time frame: Up to 30 days after hospital discharge

    Measured by the EQ-5D-5L tool

  3. Number of required morphine-equivalents

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

  4. Nausea

    Time frame: From enrollment until 30 days or hospital admission, whichever comes first

    Nausea, measured on a numeric rating scale from 0 to 10

  5. Pain from Small bowel obstruction

    Time frame: From enrollment until 30 days or hospital admission, whichever comes first

    Pain, measure on a numeric rating scale from 0-10

  6. Pain from insertion of nasogastric tube

    Time frame: From enrollment until 2 days or emergency department discharge, whichever comes first

    Patient experience pain on a NRS 0-10 scale

  7. Discomfort from nasogastric tube

    Time frame: From enrollment until 30 days or hospital admission, whichever comes first

    Patient-experience discomfort, rated on NRS (0-10) scale

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Johannesson, MSc

CONTACT

+46101030000

Jens Wretborn, Associate Professor

CONTACT

[email protected]

+46101030000

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Linkoeping University
  • Region Jönköping County

Registry information

Official study title

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

Acronym: SBO-TUBE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 8, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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