Clinical trial NCT06262815: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction
Official title: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction in Adult Patients in the Emergency Department; an Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Bowel Obstruction
Frailty
Nasogastric Tube
Keywords: Small bowel obstruction
nasogastric tube
pain
mortality
morbidity
frailty
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2024-02-16
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting any of the following Emergency Departments in Sweden:

* Linköping University Hospital
* Motala Lasarett
* Vrinnevisjukhuset Norrköping
* Sundvalls Lasarett
* Skåne University Hospital Malmö
* Skåne University Hospital Lund
* Sahlgrenska University Hospital Sahlgrenska
* Sahlgrenska University Hospital Östra

Brief summary: Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.

Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.

To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed.


Eligibility criteria: Inclusion Criteria:

* Diagnosed small bowel obstruction
* Age 18 or older

Exclusion Criteria:

* Abdominal surgery within 7 days
* Not able to give informed consent

Primary outcomes:
measure: Pain at Emergency Department discharge
timeFrame: at Emergency Department Discharge, assessed up to 48 hours
Secondary outcomes:
measure: Nausea at Emergency Department discharge
timeFrame: at Emergency Department discharge, assessed up to 48 hours
measure: Hospital Length of Stay
timeFrame: Up to 90 days from inclusion
measure: Mortality
timeFrame: up to 90 days from inclusion
measure: Admission for Small bowel obstruction
timeFrame: up to 365 days from inclusion in the study
measure: Emergency Surgery
timeFrame: up to 30 days from inclusion
measure: Emergency Department Length of Stay
timeFrame: up to 7 days from inclusion
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Göteborg
country: Sweden
facility: Östra sjukhuset
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus
city: Motala
country: Sweden
facility: Lasarett i Motala
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
city: Sundsvall
country: Sweden
facility: Sundsvalls sjukhus
city: Linköping
country: Sweden
facility: Akutmottagningen US Östergötland
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Daniel B Wilhelms, PhD
role: PRINCIPAL_INVESTIGATOR
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