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ERAS for Pediatric Acute Appendicitis (EPAA)

Primary Purpose

Pediatric Disorder, Complicated Appendicitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERAS
Sponsored by
Feng Jiexiong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Disorder focused on measuring ERAS, Pediatric surgery, Emergency, Both of systolic and diastolic will be measured

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ages<14; no gender limitation;
  • Alvarado scores ≥7;
  • preoperative radiography examination indicated appendicitis;
  • Patients or their legal representatives have signed "informed consent"

Exclusion Criteria:

  • complicated life-threatening disease;
  • perioperative exploration not appendicitis;
  • Recently participated in other clinical trials within 3 months;
  • Researchers found not fit to participate in this trial for any condition

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ERAS group

control group

Arm Description

interventions: 1.preoperative pain control; 2.avoiding application of ureter; 3.avoiding application of gastric tube; 4.avoiding application of irrigation; 5.avoiding application of drainage; 6.early exercising postoperatively; 7.early oral feeding postoperatively; 8.early discharging.

normal treatment

Outcomes

Primary Outcome Measures

length of stay
less hospital length of stay

Secondary Outcome Measures

first time for postoperative feeding
earlier postoperative feeding
first time for postoperative exercising
earlier postoperative exercising
rate of postoperative complication
less postoperative complication
rate of re-operation
less rate of re-operation
rate of re-admission
less rate of re-admission

Full Information

First Posted
October 7, 2018
Last Updated
April 3, 2023
Sponsor
Feng Jiexiong
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1. Study Identification

Unique Protocol Identification Number
NCT03712657
Brief Title
ERAS for Pediatric Acute Appendicitis
Acronym
EPAA
Official Title
Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feng Jiexiong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.
Detailed Description
The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Disorder, Complicated Appendicitis
Keywords
ERAS, Pediatric surgery, Emergency, Both of systolic and diastolic will be measured

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Experimental
Arm Description
interventions: 1.preoperative pain control; 2.avoiding application of ureter; 3.avoiding application of gastric tube; 4.avoiding application of irrigation; 5.avoiding application of drainage; 6.early exercising postoperatively; 7.early oral feeding postoperatively; 8.early discharging.
Arm Title
control group
Arm Type
No Intervention
Arm Description
normal treatment
Intervention Type
Combination Product
Intervention Name(s)
ERAS
Intervention Description
preoperative pain control; avoiding application of ureter; avoiding application of gastric tube; avoiding application of irrigation; avoiding application of drainage; early exercising postoperatively; early oral feeding postoperatively; early discharging.
Primary Outcome Measure Information:
Title
length of stay
Description
less hospital length of stay
Time Frame
through study completion, an average of 7 days
Secondary Outcome Measure Information:
Title
first time for postoperative feeding
Description
earlier postoperative feeding
Time Frame
up to 72 hours
Title
first time for postoperative exercising
Description
earlier postoperative exercising
Time Frame
1-2 days
Title
rate of postoperative complication
Description
less postoperative complication
Time Frame
1 months
Title
rate of re-operation
Description
less rate of re-operation
Time Frame
1 months
Title
rate of re-admission
Description
less rate of re-admission
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages<14; no gender limitation; Alvarado scores ≥7; preoperative radiography examination indicated complicated appendicitis; Patients or their legal representatives have signed "informed consent" Exclusion Criteria: complicated life-threatening disease; perioperative exploration not appendicitis; Recently participated in other clinical trials within 3 months; Researchers found not fit to participate in this trial for any condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiexiong Feng, MD
Phone
0028-13986086129
Email
fengjiexiong@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tianqi Zhu, MD
Phone
0028-13986295423
Email
zhutianqi84@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiexiong Feng, MD
Organizational Affiliation
Tongji Hospital, HUST, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianqi Zhu, MD PhD
Phone
13986295423
Email
zhutianqi84@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.

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ERAS for Pediatric Acute Appendicitis

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