Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion
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|ClinicalTrials.gov Identifier: NCT01125280|
Recruitment Status : Unknown
Verified May 2010 by University Hospital, Geneva.
Recruitment status was: Not yet recruiting
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Obstruction||Procedure: Conservative treatment versus surgical treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Experimental: SBO score application
Acute strangulated SBO patients will receive a severity score at emergency admission. According to the score, they will be managed either conservatively or surgically. During surgery, the need of small bowel resection will be evaluated. The endpoint will be to correlate the type and success of treatment with the score in order to validate this new tool in SBO assessment.
Procedure: Conservative treatment versus surgical treatment
Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection
- Proportion of patients with a score of 0-2 with successful conservative treatment [ Time Frame: 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.
- Proportion of patients with a score ≥3 needing small bowel resection [ Time Frame: 1 day ]Patients with a score ≥3 will be emergently operated on with a surgical delay below 12 hours since admission. During surgery, segmental small bowel resection will be performed in case of ischemia or necrosis. The need of small bowel resection will be related to the pre-operative score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125280
|Contact: Frank P Schwenter, MD, PhDfirstname.lastname@example.org|
|Contact: Philippe Morel, MDemail@example.com|
|Division of visceral and transplantation surgery, Department of surgery, Geneva University Hospital||Not yet recruiting|
|Geneva, Switzerland, 1211|
|Contact: Frank P Schwenter, MD, PhD +41223727703 firstname.lastname@example.org|
|Contact: Philippe Morel, MD +41223727702 email@example.com|
|Principal Investigator: Frank P Schwenter, MD, PhD|
|Principal Investigator:||Frank P Schwenter, MD, PhD||Geneva University Hospital|