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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
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

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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125280

Contacts
Contact: Frank P Schwenter, MD, PhD +41223727703 frank.schwenter@hcuge.ch
Contact: Philippe Morel, MD +41223727702 philippe.morel@hcuge.ch

Locations
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         
Sponsors and Collaborators
University Hospital, Geneva
Centre Hospitalier Universitaire Vaudois
Investigators
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 October 16, 2014