- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057599
Ileus After Lumbar Spine Surgery
June 13, 2022 updated by: National Taiwan University Hospital
Investigation of Postoperative Ileus After Lumbar Spine Surgery: a Prospective Observational Study
Postoperative ileus (POI) after lumbar spine surgery is not uncommon.
However, the incidence, severity and risk factors of ileus after spine surgery remain uncertain because there is not yet a prospective investigation using a subjective grading evaluation tool.
Study Overview
Status
Completed
Conditions
Detailed Description
This study aims to prospectively investigate the incidence of POI after spine surgery by using the I-FEED scoring system.
The severity of POI after spine surgery thus could be stratified and then an investigation of possible risk factors could be identified.
Study Type
Observational
Enrollment (Actual)
156
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
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Taipei, Taiwan
- National Taiwan University Hospital
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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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who undergoing elective lumbar spine surgery
Description
Adult patients who undergoing elective lumbar spine surgery
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 |
---|---|---|
Validation of the I-FEED scoring system
Time Frame: 3 days
|
Construct validation of the I-FEED scoring system to ileus-related outcome including the need of gastrointestinal medication, the length of hospital stay and in-hospital cost
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3 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 17, 2019
Primary Completion (Actual)
February 14, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
August 14, 2019
First Submitted That Met QC Criteria
August 14, 2019
First Posted (Actual)
August 15, 2019
Study Record Updates
Last Update Posted (Actual)
June 16, 2022
Last Update Submitted That Met QC Criteria
June 13, 2022
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201907033RINB
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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