ERAS for Pediatric Acute Appendicitis

Pediatric Disorder Clinical Trial

— EPAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712657
• Other study ID #: TJH
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 893
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Complicated Appendicitis
• Pediatric Disorder

Intervention

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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Feng Jiexiong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay	less hospital length of stay	through study completion, an average of 7 days
Secondary	first time for postoperative feeding	earlier postoperative feeding	up to 72 hours
Secondary	first time for postoperative exercising	earlier postoperative exercising	1-2 days
Secondary	rate of postoperative complication	less postoperative complication	1 months
Secondary	rate of re-operation	less rate of re-operation	1 months
Secondary	rate of re-admission	less rate of re-admission	1 months