The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction
- Conditions
- Small Bowel ObstructionNasogastric TubeFrailty
- Interventions
- Diagnostic Test: Clinical Frailty ScaleProcedure: Nasogastric tube placement
- Registration Number
- NCT06262815
- Lead Sponsor
- Daniel Wilhelms
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Diagnosed small bowel obstruction
- Age 18 or older
- Abdominal surgery within 7 days
- Not able to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients living with frailty Clinical Frailty Scale Subgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of \>4. Patients with nasogastric tube treatment Nasogastric tube placement Adult patients with diagnosed small bowel obstruction in the Emergency Department for a nasogastric tube was placed Patients without nasogastric tube treatment Nasogastric tube placement Adult patients with diagnosed small bowel obstruction in the Emergency Department for no nasogastric tube was placed Patients not living with frailty Clinical Frailty Scale Subgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of \<5.
- Primary Outcome Measures
Name Time Method Pain at Emergency Department discharge at Emergency Department Discharge, assessed up to 48 hours self-reported Pain on a Numeric Rating Scale from 0 to 10 were higher is worse
- Secondary Outcome Measures
Name Time Method Hospital Length of Stay Up to 90 days from inclusion Duration of days spent in the hospital by patients with Small Bowel obstruction admitted from the Emergency Department
Emergency Surgery up to 30 days from inclusion Any emergency operation
Mortality up to 90 days from inclusion Mortality of any cause
Emergency Department Length of Stay up to 7 days from inclusion Length of stay, defined as the time from registration in the Emergency Department to discharge from the Emergency Department at the visit of inclusion.
Nausea at Emergency Department discharge at Emergency Department discharge, assessed up to 48 hours Nausea as self-reported by patients on a numeric rating scale from 0 to 10 were higher is worse
Admission for Small bowel obstruction up to 365 days from inclusion in the study Any admission to a hospital in Sweden with a primary discharge diagnosis of small bowel obstruction
Trial Locations
- Locations (7)
Östra sjukhuset
🇸🇪Göteborg, Sweden
Vrinnevisjukhuset
🇸🇪Norrköping, Sweden
Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Skånes Universitetssjukhus
🇸🇪Malmö, Sweden
Lasarett i Motala
🇸🇪Motala, Sweden
Sundsvalls sjukhus
🇸🇪Sundsvall, Sweden
Akutmottagningen US Östergötland
🇸🇪Linköping, Östergötland, Sweden