A Danish Audit of Small Bowel Obstruction (DASBO)

March 5, 2024 updated by: Henry Smith, Danish Small Bowel Obstruction Collaborative

Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.

This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.

Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.

Study Type

Observational

Enrollment (Estimated)

540

Contacts and Locations

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

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Herlev Hospital
      • Copenhagen, Denmark
        • Hvidovre Hospital
      • Hillerød, Denmark
        • Hillerød Hospital
      • Køge, Denmark
        • Zealand University Hospital
      • Slagelse, Denmark
        • Slagelse Hospital
    • County
      • Copenhagen, County, Denmark, 2880
        • Bispebjerg 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted to participating centres on the island of Sjaelland, Denmark

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Radiological or clinical diagnosis of mechanical SBO
  • Admitted to one of the 6 participating centres

Exclusion Criteria:

  • SBO presenting within 30 days of a previous abdominal operation

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

Cohorts and Interventions

Group / Cohort
Small Bowel obstruction
Patients admitted with a diagnosis of small bowel obstruction at 1 of the 6 participating centres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30-day morbidity rate
Time Frame: 30 days
30 days
30-day mortality rate
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
90-day mortality rate
Time Frame: 90 days
90 days
To describe the proportion of patients undergoing operative versus non-operative management
Time Frame: From 90 days
From 90 days
To determine the success rate of non-operative management in patients with SBO and identify predictors of success/failure
Time Frame: From the start of treatment until 90-days follow-up
From the start of treatment until 90-days follow-up
To determine the incidence and consequence of acute kidney injury in patients with SBO
Time Frame: 90 days
90 days
To determine the incidence and consequence of malnourishment in patients with SBO
Time Frame: 90 days
90 days

Other Outcome Measures

Outcome Measure
Time Frame
To determine the incidence of recurrent SBO at 1-year, 3-year and 5-year follow-up.
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

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

Sponsor

Danish Small Bowel Obstruction Collaborative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 22, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-2021-70

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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