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

8 juni 2026 bijgewerkt door: Daniel Wilhelms, University Hospital, Linkoeping

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

1000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jens Wretborn, Associate Professor
  • Telefoonnummer: +46101030000
  • E-mail: jens.wretborn@liu.se

Studie Contact Back-up

  • Naam: Erika Johannesson, MSc
  • Telefoonnummer: +46101030000

Studie Locaties

  • Zweden
      • Linköping, Zweden, 58561
        • Werving
        • Linköping University Hospital
        • Contact:
      • Motala, Zweden, 59135
        • Werving
        • Motala Lasarett
        • Contact:
      • Värnamo, Zweden, 33156
        • Werving
        • Värnamo Lasarett
        • Contact:
        • Onderonderzoeker:
          • Amanda Tyrsing, MD
        • Onderonderzoeker:
          • Kaj Li, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geen tussenkomst: No Nasogastric Tube
Nasogastric tube is deferred. Other management according to local guidelines

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
Tijdsspanne: 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.
From enrollment until 30 days or hospital discharge

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Surgery
Tijdsspanne: From enrollment until 30 days or hospital discharge, whichever comes first
Requiring surgery for their small bowel obstruction
From enrollment until 30 days or hospital discharge, whichever comes first
Death
Tijdsspanne: From enrollment until 365 days
Death from any cause
From enrollment until 365 days
Time to functional recovery
Tijdsspanne: 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
From enrollment until 30 days or hospital discharge, whichever comes first
Bowel perforation
Tijdsspanne: From enrollment until 30 days or hospital discharge, whichever comes first
As a finding, or complication, during surgery
From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection
Tijdsspanne: From enrollment until 30 days or hospital discharge, whichever comes first
Bowel resection during surgery measured in cm.
From enrollment until 30 days or hospital discharge, whichever comes first
Hospital Length of Stay
Tijdsspanne: 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
Enrollment until 30 days or hospital discharge, whichever comes first
Emergency Department Length of Stay
Tijdsspanne: From emergency department registration until 2 days or emergency department discharge, whichever comes first.
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
Tijdsspanne: 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
From enrollment until 30 days or hospital discharge, whichever comes first
Readmission for small bowel obstruction
Tijdsspanne: From enrollment until 365 days
Any readmission to hospital for small bowel obstruction
From enrollment until 365 days

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recurrent Small Bowel Obstruction
Tijdsspanne: From inclusion until 365 days
Admission for small bowel obstruction
From inclusion until 365 days
Health-related quality of life
Tijdsspanne: Up to 30 days after hospital discharge
Measured by the EQ-5D-5L tool
Up to 30 days after hospital discharge
Number of required morphine-equivalents
Tijdsspanne: From inclusion until 30 days or hospital discharge, whichever comes first
From inclusion until 30 days or hospital discharge, whichever comes first
Nausea
Tijdsspanne: From enrollment until 30 days or hospital admission, whichever comes first
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
Tijdsspanne: From enrollment until 30 days or hospital admission, whichever comes first
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
Tijdsspanne: From enrollment until 2 days or emergency department discharge, whichever comes first
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
Tijdsspanne: From enrollment until 30 days or hospital admission, whichever comes first
Patient-experience discomfort, rated on NRS (0-10) scale
From enrollment until 30 days or hospital admission, whichever comes first

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Linkoeping

Medewerkers

Linkoeping University
Region Jönköping County

Onderzoekers

  • Hoofdonderzoeker: 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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 mei 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-00330-01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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