NCT01125280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 18, 2010

Status Verified

May 1, 2010

Enrollment Period

3 years

First QC Date

May 17, 2010

Last Update Submit

May 17, 2010

Conditions

Intestinal Obstruction

Keywords

Small bowel occlusionConservative treatment for small bowel occlusionSurgical treatment for small bowel occlusionSmall bowel resectionScore of severity of small bowel occlusion

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days

Secondary Outcomes (1)

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

    1 day

Study Arms (1)

SBO score application

EXPERIMENTAL

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

Interventions

Conservative treatment versus surgical treatmentPROCEDURE

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

Also known as: Laparotomy, Adhesiolysis, Small bowel resection
SBO score application

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Strangulated small bowel occlusion
  • Diagnosis confirmation by CT-scan with iv contrast
  • Blood analysis comprising: leucocyte count and repartition, CRP, lactates

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37026805DERIVED

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Frank P Schwenter, MD, PhD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank P Schwenter, MD, PhD

CONTACT

+41223727703frank.schwenter@hcuge.ch

Philippe Morel, MD

CONTACT

+41223727702philippe.morel@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 18, 2010

Record last verified: 2010-05

Locations

CH(1)