Clinical trial NCT01125280: Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion
Official title: Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Obstruction
Keywords: Small bowel occlusion
Conservative treatment for small bowel occlusion
Surgical treatment for small bowel occlusion
Small bowel resection
Score of severity of small bowel occlusion
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2010-05-18
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Proportion of patients with a score of 0-2 with successful conservative treatment
timeFrame: 3 days
Secondary outcomes:
measure: Proportion of patients with a score ≥3 needing small bowel resection
timeFrame: 1 day
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Division of visceral and transplantation surgery, Department of surgery, Geneva University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Frank P Schwenter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: