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临床试验/NCT06262815
NCT06262815进行中(未招募)不适用

The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction in Adult Patients in the Emergency Department; an Observational Multicenter Study

Daniel Wilhelms14 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
400
试验地点
14
主要终点
Pain at Emergency Department discharge

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed small bowel obstruction
  • Age 18 or older

排除标准

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

研究组 & 干预措施

Patients with nasogastric tube treatment

Adult patients with diagnosed small bowel obstruction in the Emergency Department for a nasogastric tube was placed

干预措施: Nasogastric tube placement (Procedure)

Patients without nasogastric tube treatment

Adult patients with diagnosed small bowel obstruction in the Emergency Department for no nasogastric tube was placed

干预措施: Nasogastric tube placement (Procedure)

Patients living with frailty

Subgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of >4.

干预措施: Clinical Frailty Scale (Diagnostic Test)

Patients not living with frailty

Subgroup of patients, with small bowel obstruction in the Emergency Department over 65 years of age with a clinical frailty score of <5.

干预措施: Clinical Frailty Scale (Diagnostic Test)

结局指标

主要结局

Pain at Emergency Department discharge

时间窗: 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

次要结局

  • Hospital Length of Stay(Up to 90 days from inclusion)
  • Emergency Surgery(up to 30 days from inclusion)
  • Mortality(up to 90 days from inclusion)
  • Emergency Department Length of Stay(up to 7 days from inclusion)
  • Nausea at Emergency Department discharge(at Emergency Department discharge, assessed up to 48 hours)
  • Admission for Small bowel obstruction(up to 365 days from inclusion in the study)

研究者

发起方
Daniel Wilhelms
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Wilhelms

Head of Research, Department of Emergency Medicine, Associate Professor

University Hospital, Linkoeping

研究点 (14)

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