ERASNCT05593861
Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China
An observational study of ERAS, run by Weibing Tang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ERAS
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 21 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: chief pediatric surgeons at each center
Who may be able to join
- chief pediatric surgeons at each center
Who cannot join
- Incomplete questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| This investigation was conducted on chief surgeons at each center. | This investigation was conducted on chief surgeons at each center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Element adherence
Adherence to an element was determined if the frequency of practice reached specific thresholds as defined.
Measured: immediately after all the questionnaires are collected
Secondary outcomes (1)
Factors associated with baseline ERAS utilization
Factors associated with baseline ERAS utilization
Measured: immediately after all the questionnaires are collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weibing Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weibing Tang, Nanjing Children's Hospital
- Investigators
- Hua Xie, M.M., Principal investigator, Department of pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593861
- Sponsor's protocol ID
- NanjingCH13170
- Status last verified
- Oct 2022
- First submitted
- 25 Jul 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vacek J, Davis T, Many BT, Close S, Blake S, Hu YY, Holl JL, Johnson J, Strople J, Raval MV. A baseline assessment of enhanced recovery protocol implementation at pediatric surgery practices performing inflammatory bowel disease operations. J Pediatr Surg. 2020 Oct;55(10):1996-2006. doi: 10.1016/j.jpedsurg.2020.06.021. Epub 2020 Jun 27.
PubMed 32713714
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China: Based on a Survey of Performing Congenital Biliary Dilatation Operations
- ClinicalTrials.gov ID
- NCT05593861
- Acronym / sponsor ID
- NanjingCH13170
- Conditions
- ERAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Weibing TangUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 25 Oct 2022 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This investigation was conducted on chief surgeons at each center. | – | –This investigation was conducted on chief surgeons at each center. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- chief pediatric surgeons at each center
Key inclusion criteria (1 listed)
- chief pediatric surgeons at each center
Key exclusion criteria (1 listed)
- Incomplete questionnaire
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
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.
1 secondary outcome
Factors associated with baseline ERAS utilization
Time frame: immediately after all the questionnaires are collected
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 25 Oct 2022.
- Background: PubMed 32713714Vacek J, Davis T, Many BT, Close S, Blake S, Hu YY, Holl JL, Johnson J, Strople J, Raval MV. A baseline assessment of enhanced recovery protocol implementation at pediatric surgery practices performing inflammatory bowel disease operations. J Pediatr Surg. 2020 Oct;55(10):1996-2006. doi: 10.1016/j.jpedsurg.2020.06.021. Epub 2020 Jun 27.
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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.
Hua Xie, M.M. principal investigator
Department of pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.
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 ERAS, run by Weibing Tang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 25 Oct 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 China. 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?
Element adherence (time frame: immediately after all the questionnaires are collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593861, which also lists 1 linked publication.
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 25 Oct 2022.