Lumbar Spine Surgery Postoperative IleusNCT04057599
Ileus After Lumbar Spine Surgery
An observational study of Lumbar Spine Surgery Postoperative Ileus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lumbar Spine Surgery Postoperative Ileus
- How many people
- 156 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergoing elective lumbar spine surgery
Adult patients who undergoing elective lumbar spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Spine Surgery Postoperative Ileus
- Keywords
- post-operative ileus,lumbar spine surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the I-FEED scoring system
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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start17 Aug 2019
- Primary completion14 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine Surgery Postoperative IleusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fon-Yih Tsuang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057599
- Sponsor's protocol ID
- 201907033RINB
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Postoperative Ileus After Lumbar Spine Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04057599
- Acronym / sponsor ID
- 201907033RINB
- Conditions
- Lumbar Spine Surgery Postoperative Ileus
- Keywords
- post-operative ileus,lumbar spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Aug 2019 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergoing elective lumbar spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fon-Yih Tsuang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Surgery Postoperative Ileus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the I-FEED scoring system (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.