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

Primary Purpose

Intestinal Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Conservative treatment versus surgical treatment
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Obstruction focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Division of visceral and transplantation surgery, Department of surgery, Geneva University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBO score application

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of patients with a score of 0-2 with successful conservative treatment
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.

Secondary Outcome Measures

Proportion of patients with a score ≥3 needing small bowel resection
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.

Full Information

First Posted
May 17, 2010
Last Updated
May 17, 2010
Sponsor
University Hospital, Geneva
Collaborators
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT01125280
Brief Title
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva
Collaborators
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBO score application
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Conservative treatment versus surgical treatment
Other Intervention Name(s)
Laparotomy, Adhesiolysis, Small bowel resection
Intervention Description
Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection
Primary Outcome Measure Information:
Title
Proportion of patients with a score of 0-2 with successful conservative treatment
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Proportion of patients with a score ≥3 needing small bowel resection
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank P Schwenter, MD, PhD
Phone
+41223727703
Email
frank.schwenter@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Morel, MD
Phone
+41223727702
Email
philippe.morel@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank P Schwenter, MD, PhD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of visceral and transplantation surgery, Department of surgery, Geneva University Hospital
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank P Schwenter, MD, PhD
Phone
+41223727703
Email
frank.schwenter@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Philippe Morel, MD
Phone
+41223727702
Email
philippe.morel@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Frank P Schwenter, MD, PhD

12. IPD Sharing Statement

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

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