Diagnostic Scoring for Small Bowel Obstruction

January 8, 2024 updated by: Ville Sallinen, Helsinki University Central Hospital
It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. The rationale for this observative study is to collect prospective cohort of patients with small bowel obstruction to create scoring system to predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

482

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Espoo, Finland
        • Helsinki University Hospital, Jorvi hospital
      • Helsinki, Finland
        • Helsinki University Hospital, Meilahti hospital
      • Hyvinkää, Finland
        • Hyvinkää Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients presenting to surgical ER with abdominal complain are screened.

Description

Inclusion Criteria:

  • Computed tomography verified acute small bowel obstruction

Exclusion Criteria:

  • < 18 years old
  • Pregnant
  • Abdominal surgery within 30 days prior recruitment
  • Inflammatory bowel disease
  • Small bowel tumor causing obstruction
  • Peritoneal carcinosis
  • Intraluminal obstruction (bile stone, bezoar, etc.)
  • Large bowel obstruction
  • Small bowel obstruction caused by abdominal wall hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strangulation
Time Frame: Within hospital stay / 30 days from recruitment
Number of patients with strangulated bowel (reversible or irreversible ischemic bowel)
Within hospital stay / 30 days from recruitment
Need for surgery due to nonresolving small bowel obstruction
Time Frame: Within hospital stay / 30 days from recruitment
Number of patients needing surgery due to nonresolving small bowel obstruction
Within hospital stay / 30 days from recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Ville Sallinen, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBO-DG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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