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

NCT ID: NCT01125280

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-07-31

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.

Conditions

Intestinal Obstruction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Conservative treatment versus surgical treatment

Intervention Type: PROCEDURE

Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection

Interventions

Conservative treatment versus surgical treatment

Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection

Intervention Type: PROCEDURE

Other Intervention Names

Laparotomy; Adhesiolysis; Small bowel resection

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Geneva University Hospital, Department of Surgery

Principal Investigators

Frank P Schwenter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Central Contacts

Frank P Schwenter, MD, PhD

Role: CONTACT

frank.schwenter@hcuge.ch

+41223727703

Philippe Morel, MD

Role: CONTACT

philippe.morel@hcuge.ch

+41223727702

Facility Contacts

Frank P Schwenter, MD, PhD

Role: primary

frank.schwenter@hcuge.ch

+41223727703

Philippe Morel, MD

Role: backup

philippe.morel@hcuge.ch

+41223727702

References

Wassmer CH, Revol R, Uhe I, Chevallay M, Toso C, Gervaz P, Morel P, Poletti PA, Platon A, Ris F, Schwenter F, Perneger T, Meier RPH. A new clinical severity score for the management of acute small bowel obstruction in predicting bowel ischemia: a cohort study. Int J Surg. 2023 Jun 1;109(6):1620-1628. doi: 10.1097/JS9.0000000000000171.

Reference Type: DERIVED

PMID: 37026805 (View on PubMed)

Other Identifiers

NAC 10-009

Identifier Type: -

Identifier Source: org_study_id