- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05593861
Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China
October 22, 2022 updated by: Weibing Tang
Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China: Based on a Survey of Performing Congenital Biliary Dilatation Operations
Enhanced recovery after surgery (ERAS) is a new mode to optimize perioperative management, the core of which is to reduce perioperative physiological and psychological trauma and stress damage, and accelerate postoperative rehabilitation.
ERAS has been gradually introduced in pediatric surgery in recent years, however, there are limited reports on its overall implementation.
We aimed to determine the popularity of ERAS among pediatric populations in mainland China.
Study Overview
Status
Completed
Conditions
Detailed Description
The application of ERAS in children with congenital biliary dilatation (CBD) was investigated.
A total of 31 province-level administrative regions in mainland China were involved and each of them had at least one participating center.
A questionnaire was designed to assess the baseline adherence of 17 recovery elements and chief pediatric surgeons at each center were invited to complete.
Study Type
Observational
Enrollment (Actual)
66
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
-
-
Jiangsu
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Nanjing, Jiangsu, China
- NJMU
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
chief pediatric surgeons at each center
Description
Inclusion Criteria:
- chief pediatric surgeons at each center
Exclusion Criteria:
- Incomplete questionnaire
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 |
|---|
|
This investigation was conducted on chief surgeons at each center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Element adherence
Time Frame: immediately after all the questionnaires are collected
|
Adherence to an element was determined if the frequency of practice reached specific thresholds as defined.
|
immediately after all the questionnaires are collected
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors associated with baseline ERAS utilization
Time Frame: immediately after all the questionnaires are collected
|
Factors associated with baseline ERAS utilization
|
immediately after all the questionnaires are collected
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barriers to implementation
Time Frame: immediately after all the questionnaires are collected
|
Barriers to implementation
|
immediately after all the questionnaires are collected
|
|
Outcomes of concern
Time Frame: immediately after all the questionnaires are collected
|
Outcomes of concern
|
immediately after all the questionnaires are collected
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hua Xie, M.M., Department of pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.
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.
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)
July 1, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
July 21, 2022
Study Registration Dates
First Submitted
July 25, 2022
First Submitted That Met QC Criteria
October 22, 2022
First Posted (Actual)
October 25, 2022
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 22, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- NanjingCH13170
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.