Intestinal Obstruction Clinical Trial
Official title:
Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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