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ERAS for Pediatric Acute Appendicitis

NCT ID: NCT03712657

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

893 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-10-31

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.

Conditions

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Pediatric Disorder Complicated Appendicitis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ERAS group

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.

Group Type EXPERIMENTAL

ERAS

Intervention Type 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.

control group

normal treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ERAS

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.

Intervention Type COMBINATION_PRODUCT

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Feng Jiexiong

OTHER

Sponsor Role lead

Responsible Party

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Feng Jiexiong

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jiexiong Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital, HUST, China

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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TJH

Identifier Type: -

Identifier Source: org_study_id