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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04057599
Other study ID # 201907033RINB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2019
Est. completion date February 28, 2022

Study information

Verified date August 2019
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date February 28, 2022
Est. primary completion date February 14, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Adult patients who undergoing elective lumbar spine surgery

Study Design


Related Conditions & MeSH terms

  • Ileus
  • Lumbar Spine Surgery Postoperative Ileus

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 days