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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Composite of Pulmonary complications and care at a high dependency unit or intensive care unit [Срок оценки: From enrollment until 30 days or hospital discharge]

Вторичные конечные точки (9)

• Surgery [Срок оценки: From enrollment until 30 days or hospital discharge, whichever comes first]
• Death [Срок оценки: From enrollment until 365 days]
• Time to functional recovery [Срок оценки: From enrollment until 30 days or hospital discharge, whichever comes first]
• Bowel perforation [Срок оценки: From enrollment until 30 days or hospital discharge, whichever comes first]
• Bowel resection [Срок оценки: From enrollment until 30 days or hospital discharge, whichever comes first]
• Hospital Length of Stay [Срок оценки: Enrollment until 30 days or hospital discharge, whichever comes first]
• Emergency Department Length of Stay [Срок оценки: From emergency department registration until 2 days or emergency department discharge, whichever comes first.]
• Time to resolved small bowel obstruction [Срок оценки: From enrollment until 30 days or hospital discharge, whichever comes first]
• Readmission for small bowel obstruction [Срок оценки: From enrollment until 365 days]

Критерии участия

Критерии включения

• Small bowel obstruction diagnosed on Computer Tomography

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 3 центра

• Linköping University Hospital — Linköping
• Motala Lasarett — Motala
• Värnamo Lasarett — Värnamo

Идентификаторы

NCT: NCT07574515 · 2026-00330-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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