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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
| Region Jönköping County | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasogastric Tube | Experimental | This arm receives a nasogastric tube. Other management according to local guidelines. |
|
| No Nasogastric Tube | No Intervention | Nasogastric tube is deferred. Other management according to local guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasogastric tube placement | Procedure | The placement of a nasogastric tube from the nares to gastric ventricle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pulmonary complications and care at a high dependency unit or intensive care unit | Pulmonary complications, any of:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery | Requiring surgery for their small bowel obstruction | From enrollment until 30 days or hospital discharge, whichever comes first |
| Death | Death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Small Bowel Obstruction | Admission for small bowel obstruction | From inclusion until 365 days |
| Health-related quality of life | Measured by the EQ-5D-5L tool |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Wretborn, Associate Professor | Contact | +46101030000 | jens.wretborn@liu.se | |
| Erika Johannesson, MSc | Contact | +46101030000 |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University Hospital | Recruiting | Linköping | 58561 | Sweden |
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| From enrollment until 365 days |
| Time to functional recovery | 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:
| From enrollment until 30 days or hospital discharge, whichever comes first |
| Bowel perforation | As a finding, or complication, during surgery | From enrollment until 30 days or hospital discharge, whichever comes first |
| Bowel resection | Bowel resection during surgery measured in cm. | From enrollment until 30 days or hospital discharge, whichever comes first |
| Hospital Length of Stay | 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 | 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 | 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 | Any readmission to hospital for small bowel obstruction | From enrollment until 365 days |
| Up to 30 days after hospital discharge |
| Number of required morphine-equivalents | From inclusion until 30 days or hospital discharge, whichever comes first |
| Nausea | 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 | 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 | 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 | Patient-experience discomfort, rated on NRS (0-10) scale | From enrollment until 30 days or hospital admission, whichever comes first |
| Motala Lasarett | Recruiting | Motala | 59135 | Sweden |
|
| Värnamo Lasarett | Recruiting | Värnamo | 33156 | Sweden |
|
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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