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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03712657
Other study ID # TJH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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