ERAS for Pediatric Acute Appendicitis

NCT03712657 | Completed

• 1 other identifier: TJH
• Study Type: interventional
• Target: 893
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Disorder; Complicated Appendicitis

Keywords

ERAS; Pediatric surgery; Emergency; Both of systolic and diastolic will be measured

Outcome Measures

Primary Outcomes (1)

• length of stay

  less hospital length of stay

  through study completion, an average of 7 days

Secondary Outcomes (5)

• first time for postoperative feeding

  up to 72 hours

• first time for postoperative exercising

  1-2 days

• rate of postoperative complication

  1 months

• rate of re-operation

  1 months

• rate of re-admission

  1 months

Study Arms (2)

ERAS group

EXPERIMENTAL

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

control group

NO INTERVENTION

normal treatment

Interventions

ERAS COMBINATION_PRODUCT

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.

ERAS group

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages\<14; no gender limitation;
• Alvarado scores ≥7;
• preoperative radiography examination indicated complicated appendicitis;
• Patients or their legal representatives have signed "informed consent"

You may not qualify if:

• 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

Sponsors & Collaborators

• Feng Jiexiong: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiexiong Feng, MD

  Tongji Hospital, HUST, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 19, 2018
• Study Start: January 10, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)