ERASNCT04870242
Studding the Implementation of ERAS Protocols in Pediatric Surgery
An observational study of ERAS and Pediatric Disorder, run by University of Jordan at 1 site in Jordan.
Trial summary
this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols, in pediatric surgery and evaluate the feasibility and effectiveness of implementing these protocols Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- ERAS, Pediatric Disorder, Appendicitis
- What is being tested?
- Observational study, non-interventional
- How many people
- 178 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2020to 1 Mar 2021
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution
Who may be able to join
- all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution
Who cannot join
- patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery in Pediatric Surgery in Jordan: A Retrospective Cohort Study in a Tertiary University Hospital
this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols, in pediatric surgery and evaluate the feasibility and effectiveness of implementing these protocols
- Conditions
- ERAS, Pediatric Disorder, Appendicitis, Hydrocele
- Being tested
- Observational study, non-interventional
- Keywords
- Enhanced recovery after surgery (ERAS), enhanced recovery protocol, fast-track surgery, pediatric surgery
- Medical subject headings
- Appendicitis, Testicular Hydrocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, non-interventionalOther
observational study for the ERAS protocols in pediatric surgery
| Study group | Role | What they receive |
|---|---|---|
| pediatric surgery patients | all pediatric surgery patients, aged from 6 months up to 18 years, underwent surgery between January 2017 to December 2018 Receives: Other: Observational study, non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Hospital stay,
Measured: retrospectively studied. data collection done at least 1 year after surgery
Total Hospital expenses
Measured: retrospectively studied. data collection done at least 1 year after surgery
readmission within 30 days
Measured: retrospectively studied. data collection done at least 1 year after surgery
reoperation within 90 days
Measured: retrospectively studied. data collection done at least 1 year after surgery
post op ER visits
Measured: retrospectively studied. data collection done at least 1 year after surgery
Pain control, according to a scale from 0-10, post-operative pain after implementation of ERAS protocols
Measured: retrospectively studied. data collection done at least 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 May 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Abu-Shanab, University of Jordan
- Investigators
- Raed Al-Taher, M.D, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870242
- Sponsor's protocol ID
- 67/2019/6216
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery in Pediatric Surgery in Jordan: A Retrospective Cohort Study in a Tertiary University Hospital
- ClinicalTrials.gov ID
- NCT04870242
- Acronym / sponsor ID
- 67/2019/6216
- Conditions
- ERAS, Pediatric Disorder, Appendicitis, Hydrocele
- Keywords
- Enhanced recovery after surgery (ERAS), enhanced recovery protocol, fast-track surgery, pediatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 3 May 2021 (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.
this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols, in pediatric surgery and evaluate the feasibility and effectiveness of implementing these protocols
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric surgery patients | – | Other: Observational study, non-interventionalall pediatric surgery patients, aged from 6 months up to 18 years, underwent surgery between January 2017 to December 2018 |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution
Key inclusion criteria (1 listed)
- all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution
Key exclusion criteria (1 listed)
- patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, non-interventionalobservational study for the ERAS protocols in pediatric surgery | Other | pediatric surgery patients |
Primary outcome
Duration of Hospital stay,
Time frame: retrospectively studied. data collection done at least 1 year after surgery
Total Hospital expenses
Time frame: retrospectively studied. data collection done at least 1 year after surgery
readmission within 30 days
Time frame: retrospectively studied. data collection done at least 1 year after surgery
reoperation within 90 days
Time frame: retrospectively studied. data collection done at least 1 year after surgery
post op ER visits
Time frame: retrospectively studied. data collection done at least 1 year after surgery
Pain control, according to a scale from 0-10, post-operative pain after implementation of ERAS protocols
Time frame: retrospectively studied. data collection done at least 1 year after surgery
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 3 May 2021.
- Individual participant dataSharing planned: No
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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.
Raed Al-Taher, M.D principal investigator
University of Jordan
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 and Pediatric Disorder, run by University of Jordan at 1 site in Jordan.
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 3 May 2021. 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 Jordan. 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?
Duration of Hospital stay, (time frame: retrospectively studied. data collection done at least 1 year after surgery). The study lists 6 primary outcomes in all. 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 3 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.