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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 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jens Wretborn, Associate Professor
  • Numero di telefono: +46101030000
  • Email: jens.wretborn@liu.se

Backup dei contatti dello studio

  • Nome: Erika Johannesson, MSc
  • Numero di telefono: +46101030000

Luoghi di studio

  • Svezia
      • Linköping, Svezia, 58561
        • Reclutamento
        • Linköping University Hospital
        • Contatto:
      • Motala, Svezia, 59135
        • Reclutamento
        • Motala Lasarett
        • Contatto:
      • Värnamo, Svezia, 33156
        • Reclutamento
        • Värnamo Lasarett
        • Contatto:
        • Sub-investigatore:
          • Amanda Tyrsing, MD
        • Sub-investigatore:
          • Kaj Li, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nasogastric Tube
This arm receives a nasogastric tube. Other management according to local guidelines.
Procedura: Nasogastric tube placement
The placement of a nasogastric tube from the nares to gastric ventricle.
Nessun intervento: No Nasogastric Tube
Nasogastric tube is deferred. Other management according to local guidelines

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite of Pulmonary complications and care at a high dependency unit or intensive care unit
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Surgery
Lasso di tempo: 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
Lasso di tempo: From enrollment until 365 days
Death from any cause
From enrollment until 365 days
Time to functional recovery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From enrollment until 365 days
Any readmission to hospital for small bowel obstruction
From enrollment until 365 days

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Recurrent Small Bowel Obstruction
Lasso di tempo: From inclusion until 365 days
Admission for small bowel obstruction
From inclusion until 365 days
Health-related quality of life
Lasso di tempo: 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
Lasso di tempo: From inclusion until 30 days or hospital discharge, whichever comes first
From inclusion until 30 days or hospital discharge, whichever comes first
Nausea
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Linkoeping

Collaboratori

Linkoeping University
Region Jönköping County

Investigatori

  • Investigatore principale: 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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 maggio 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-00330-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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