Small Bowel Obstruction, Intestinal Obstruction and Ileus
Conditions
Keywords
ileus, small bowel obstruction, nasogastric tube
Brief summary
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. We plan to 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
Interventions
PROCEDURENasogastric tube placement
The placement of a nasogastric tube from the nares to gastric ventricle.
Sponsors
University Hospital, Linkoeping
Linkoeping University
Region Jönköping County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Pulmonary complications and care at a high dependency unit or intensive care unit | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgery | From enrollment until 30 days or hospital discharge, whichever comes first | Requiring surgery for their small bowel obstruction |
| Death | From enrollment until 365 days | Death from any cause |
| Time to functional recovery | 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 |
| Bowel perforation | From enrollment until 30 days or hospital discharge, whichever comes first | As a finding, or complication, during surgery |
| Bowel resection | From enrollment until 30 days or hospital discharge, whichever comes first | Bowel resection during surgery measured in cm. |
| Hospital Length of Stay | 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 |
| Emergency Department Length of Stay | From emergency department registration until 2 days or emergency department discharge, whichever comes first. | The duration the research subject stays in the Emergency Department |
| Time to resolved small bowel obstruction | 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 |
| Readmission for small bowel obstruction | From enrollment until 365 days | Any readmission to hospital for small bowel obstruction |
Countries
Sweden
Contacts
CONTACTJens Wretborn, Associate Professor
CONTACTErika Johannesson, MSc
PRINCIPAL_INVESTIGATORJens Wretborn, Associate Professor
Clinical Department of Emergency Medicine in Linköping, Region Östergötland, Linköping, Sweden; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
Outcome results
None listed