ERAS for Pediatric Acute Appendicitis (EPAA)

Feng Jiexiong

Status: Completed

Conditions: Pediatric Disorder; Complicated Appendicitis

Treatments: Combination Product: ERAS

Study type: Interventional

Funder types: Other

Identifiers

NCT03712657

TJH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 893 patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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893 participants in 2 patient groups

ERAS group

Experimental group

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.

Treatment:

Combination Product: ERAS

control group

No Intervention group

Description:

normal treatment