ERAS for Pediatric Acute Appendicitis

Not Applicable

Completed

• Conditions: Pediatric Disorder; Complicated Appendicitis
• Interventions: Combination Product: ERAS

• Registration Number: NCT03712657
• Lead Sponsor: Feng Jiexiong

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.

Study Timeline

• Study First Submitted: 2018-10-07
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2022-01-10
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 893

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS	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.

Primary Outcome Measures

Name	Time	Method
length of stay	through study completion, an average of 7 days	less hospital length of stay

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China