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临床试验/NCT01125280
NCT01125280Unknown不适用

Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Proportion of patients with a score of 0-2 with successful conservative treatment

研究概览

简要总结

The purpose of this study is to apply and validate a clinicoradiological score for the prediction of severity of strangulated small bowel occlusion (SBO). This score was elaborated by analyzing clinical, biological and radiological parameters of patients admitted in an emergency center for acute strangulated SBO. Two clinical, two biological and two radiological parameters were shown to significantly predict the surgical outcome of SBO patients.

Since any delay in the management of SBO may result in devastating consequences, a score predicting the severity of the SBO episode is an essential tool for helping in the management of SBO patients. A prospective multicenter validation of the score is mandatory for its extended use.

详细描述

Elaboration of the SBO score:

Intestinal ischaemia as a result of small bowel obstruction (SBO) requires prompt recognition and early intervention. A clinicoradiological score was sought to predict the risk of ischaemia in patients with SBO. A determined protocol for the assessment of patients presenting with SBO was used. A logistic regression model was applied to identify determinant variables and construct a clinical score that would predict ischaemia requiring resection. Of 233 successive patients with SBO, 138 required laparotomy of whom 45 underwent intestinal resection. In multivariable analysis, six variables correlated with small bowel resection and were given one point each towards the clinical score: history of pain lasting more than 4 days, guarding, C-reactive protein level at least 75 mg/l, leucocyte count over 10 G/l, free intraperitoneal fluid volume exceeding 500 ml on computed tomography (CT) and reduction of CT small bowel wall contrast enhancement. The risk of intestinal ischaemia was 6 per cent in patients with a score of 1 or less, whereas 21 of 29 patients with a score of three or more 3 underwent small bowel resection. A positive score of 3 or more had a sensitivity of 67.7 per cent and specificity 90.8 per cent; the area under the receiver operating characteristics curve was 0.87 (95 per cent confidence interval 0.79 to 0.95). By combining clinical, laboratory and radiological parameters, the clinical score allowed early identification of strangulated SBO.

The purpose of the present protocol is to apply the SBO score as a prospective multicenter study. After informed consent, SBO patients corresponding to the inclusion and exclusion criteria will be managed according to the score. Patients with a score of 0 to 2 will be treated conservatively, while a score ≥3 will imply emergency surgery. For its validation, the conservative and surgical outcomes will be compared with the results obtained for the elaboration of the score.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Strangulated small bowel occlusion
  • Diagnosis confirmation by CT-scan with iv contrast
  • Blood analysis comprising: leucocyte count and repartition, CRP, lactates

排除标准

  • Large bowel occlusion
  • Strangulated hernia
  • Tumor occlusion
  • Post-Radiotherapy occlusion
  • Paralytic ileus (neurological diseases, diabetes, etc)
  • Inflammatory bowel diseases
  • Any condition able to modify the clinical or biological parameters without any relation with the SBO episode (inflammatory, infectious diseases, etc)

结局指标

主要结局

Proportion of patients with a score of 0-2 with successful conservative treatment

时间窗: 3 days

According to the score, patients will be managed either conservatively or surgically. Patients with a score of 0-2 will be treated conservatively. The success of the decision and the treatment will be evaluated after 3 days since admission. Indeed, patients with conservative treatment who do not retrieve a gastrointestinal transit after 3 days will be operated on.

次要结局

  • Proportion of patients with a score ≥3 needing small bowel resection(1 day)

研究者

申办方类型
Other

研究点 (2)

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