NCT04870242

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

April 29, 2021

Last Update Submit

April 29, 2021

Conditions

Keywords

Enhanced recovery after surgery (ERAS)enhanced recovery protocolfast-track surgerypediatric surgery

Outcome Measures

Primary Outcomes (6)

  • Duration of Hospital stay,

    retrospectively studied. data collection done at least 1 year after surgery

  • Total Hospital expenses

    retrospectively studied. data collection done at least 1 year after surgery

  • readmission within 30 days

    retrospectively studied. data collection done at least 1 year after surgery

  • reoperation within 90 days

    retrospectively studied. data collection done at least 1 year after surgery

  • post op ER visits

    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

    retrospectively studied. data collection done at least 1 year after surgery

Study Arms (1)

pediatric surgery patients

all pediatric surgery patients, aged from 6 months up to 18 years, underwent surgery between January 2017 to December 2018

Other: Observational study, non-interventional

Interventions

observational study for the ERAS protocols in pediatric surgery

pediatric surgery patients

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution

You may qualify if:

  • all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution

You may not qualify if:

  • patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Jordan

Amman, Amman, Jordan, 11941, Jordan

Location

MeSH Terms

Conditions

AppendicitisTesticular Hydrocele

Interventions

Observation

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesTesticular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Raed Al-Taher, M.D

    University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 3, 2021

Study Start

May 1, 2020

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations