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Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University Hospital, Geneva.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01125280
First received: May 17, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 17, 2010
May 17, 2010
July 2010
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Intestinal Obstruction
Procedure: Conservative treatment versus surgical treatment
Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection
Other Names:
  • Laparotomy
  • Adhesiolysis
  • Small bowel resection
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.
Intervention: Procedure: Conservative treatment versus surgical treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
July 2013
July 2013   (final data collection date for primary outcome measure)

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)
Both
16 Years and older
No
Contact: Frank P Schwenter, MD, PhD +41223727703 frank.schwenter@hcuge.ch
Contact: Philippe Morel, MD +41223727702 philippe.morel@hcuge.ch
Switzerland
 
NCT01125280
NAC 10-009
No
Schwenter Frank, MD, PhD, Geneva University Hospital, Department of Surgery
University Hospital, Geneva
Centre Hospitalier Universitaire Vaudois
Principal Investigator: Frank P Schwenter, MD, PhD Geneva University Hospital
University Hospital, Geneva
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP