- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870242
Studding the Implementation of ERAS Protocols in Pediatric Surgery
April 29, 2021 updated by: Ahmad Abu-Shanab, University of Jordan
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
178
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
-
-
Amman, Jordan
-
Amman, Amman, Jordan, Jordan, 11941
- University of Jordan
-
-
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
6 months to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution
Description
Inclusion Criteria:
- all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution
Exclusion Criteria:
- patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.
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 |
Intervention / Treatment |
|---|---|
|
pediatric surgery patients
all pediatric surgery patients, aged from 6 months up to 18 years, underwent surgery between January 2017 to December 2018
|
observational study for the ERAS protocols in pediatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of Hospital stay,
Time Frame: retrospectively studied. data collection done at least 1 year after surgery
|
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
|
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
|
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
|
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
|
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
|
retrospectively studied. data collection done at least 1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raed Al-Taher, M.D, University of Jordan
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)
May 1, 2020
Primary Completion (ACTUAL)
February 1, 2021
Study Completion (ACTUAL)
March 1, 2021
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (ACTUAL)
May 3, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67/2019/6216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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