Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion
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Purpose
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 | Intervention |
|---|---|
|
Intestinal Obstruction |
Procedure: Conservative treatment versus surgical treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion |
- Proportion of patients with a score of 0-2 with successful conservative treatment [ Time Frame: 3 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Procedure: Conservative treatment versus surgical treatment
Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection
Other Names:
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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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Frank P Schwenter, MD, PhD | +41223727703 | frank.schwenter@hcuge.ch |
| Contact: Philippe Morel, MD | +41223727702 | philippe.morel@hcuge.ch |
| Switzerland | |
| 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 frank.schwenter@hcuge.ch | |
| Contact: Philippe Morel, MD +41223727702 philippe.morel@hcuge.ch | |
| Principal Investigator: Frank P Schwenter, MD, PhD | |
| Principal Investigator: | Frank P Schwenter, MD, PhD | Geneva University Hospital |
More Information
No publications provided
| Responsible Party: | Schwenter Frank, MD, PhD, Geneva University Hospital, Department of Surgery |
| ClinicalTrials.gov Identifier: | NCT01125280 History of Changes |
| Other Study ID Numbers: | NAC 10-009 |
| Study First Received: | May 17, 2010 |
| Last Updated: | May 17, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Geneva:
|
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 |
Additional relevant MeSH terms:
|
Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013