Small Bowel Obstruction. A Prospective Multicener Study (SBO)

November 29, 2023 updated by: Liis Jaanimäe, University of Tartu

A Multicenter Prospective Study on Small Bowel Obstruction

To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter prospective study conducted at two regional hospitals of Estonia: Tartu University Hospital and North Estonian Medical Center. The data of the patients' hospitalized for SBO between May 2021 and April 2022 were collectedafter patients gave their informed consent to be enrolled in the study.

Eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study.

Characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (WBC), C-reactive protein (CRP), lactate level (Lac), estimated glomerular filtration rate (eGFR)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. It was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. In the case of conservative treatment, it was recorded whether contrast media (CM) was or was not used. In the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.

Study Type

Observational

Enrollment (Actual)

214

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

  • Estonia
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50406
        • Tartu University 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients hospitalized with mechanical small bowel obstruction

Description

Inclusion Criteria:

  • aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form

Exclusion Criteria:

  • Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients hospitalized with small bowel obstruction
Patients hospitalized with a certain diagnosis during a certain period of time
Other: No intervention is planned
Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution on SBO
Time Frame: Hospitalization period (approximately 5 days)
Resolution of small bowel obstruction (passing gas/flatus, contrast media in the colon on the X-ray )
Hospitalization period (approximately 5 days)

Collaborators and Investigators

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

Sponsor

University of Tartu

Collaborators

North Estonian Medical Center

Investigators

  • Principal Investigator: Liis Jaanimäe, University of Tartu

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)

May 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

December 4, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Patients identification numbers will be pseudonymed- the key is in a secure server and will only be accessed through smart-ID identification

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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