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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 aktualisiert von: 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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

1000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Erika Johannesson, MSc
  • Telefonnummer: +46101030000

Studienorte

  • Schweden
      • Linköping, Schweden, 58561
        • Rekrutierung
        • Linköping University Hospital
        • Kontakt:
      • Motala, Schweden, 59135
        • Rekrutierung
        • Motala Lasarett
        • Kontakt:
      • Värnamo, Schweden, 33156
        • Rekrutierung
        • Värnamo Lasarett
        • Kontakt:
        • Unterermittler:
          • Amanda Tyrsing, MD
        • Unterermittler:
          • Kaj Li, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Nasogastric Tube
This arm receives a nasogastric tube. Other management according to local guidelines.
Verfahren: Nasogastric tube placement
The placement of a nasogastric tube from the nares to gastric ventricle.
Kein Eingriff: No Nasogastric Tube
Nasogastric tube is deferred. Other management according to local guidelines

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Surgery
Zeitfenster: 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
Zeitfenster: From enrollment until 365 days
Death from any cause
From enrollment until 365 days
Time to functional recovery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From enrollment until 365 days
Any readmission to hospital for small bowel obstruction
From enrollment until 365 days

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recurrent Small Bowel Obstruction
Zeitfenster: From inclusion until 365 days
Admission for small bowel obstruction
From inclusion until 365 days
Health-related quality of life
Zeitfenster: 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
Zeitfenster: From inclusion until 30 days or hospital discharge, whichever comes first
From inclusion until 30 days or hospital discharge, whichever comes first
Nausea
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Linkoeping

Mitarbeiter

Linkoeping University
Region Jönköping County

Ermittler

  • Hauptermittler: 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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

8. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-00330-01

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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