ERAS for Pediatric Acute Appendicitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Disorder, Complicated Appendicitis

Intervention / Treatment
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* Combination Product: ERAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>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<br>* 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.<br>|
| No Intervention: control group<br>normal treatment | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Both of systolic and diastolic will be measured, ERAS, Pediatric surgery, Emergency