ERAS for Pediatric Acute Appendicitis (EPAA)

Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Disorder; Complicated Appendicitis
• Intervention / Treatment: Combination product: ERAS

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.

• Study Type: Interventional
• Enrollment (Actual): 893
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS group; 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.	Combination product: ERAS; 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.
No Intervention: control group; normal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	less hospital length of stay	through study completion, an average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first time for postoperative feeding	earlier postoperative feeding	up to 72 hours
first time for postoperative exercising	earlier postoperative exercising	1-2 days
rate of postoperative complication	less postoperative complication	1 months
rate of re-operation	less rate of re-operation	1 months
rate of re-admission	less rate of re-admission	1 months

Collaborators and Investigators

• Sponsor: Feng Jiexiong
• Investigators: Principal Investigator: Jiexiong Feng, MD, Tongji Hospital, HUST, China

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Emergency; ERAS; Pediatric surgery; Both of systolic and diastolic will be measured
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: TJH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel. requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No