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ERAS for Pediatric Acute Appendicitis (EPAA)

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ClinicalTrials.gov Identifier: NCT03712657
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Tongji Hospital

Brief Summary:
This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.

Condition or disease Intervention/treatment Phase
Pediatric Disorder Appendicitis Combination Product: ERAS Not Applicable

Detailed Description:
The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis
Estimated Study Start Date : October 8, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : October 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Experimental: 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.
Combination Product: 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.

No Intervention: conservative group
normal treatment



Primary Outcome Measures :
  1. length of stay [ Time Frame: through study completion, an average of 7 days ]
    less hospital length of stay


Secondary Outcome Measures :
  1. first time for postoperative feeding [ Time Frame: up to 72 hours ]
    earlier postoperative feeding

  2. first time for postoperative exercising [ Time Frame: 1-2 days ]
    earlier postoperative exercising

  3. rate of postoperative complication [ Time Frame: 1 months ]
    less postoperative complication

  4. rate of re-operation [ Time Frame: 1 months ]
    less rate of re-operation

  5. rate of re-admission [ Time Frame: 1 months ]
    less rate of re-admission



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ages<14; no gender limitation;
  • Alvarado scores ≥7;
  • preoperative radiography examination indicated 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712657


Contacts
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Contact: Jiexiong Feng, MD 0028-13986086129 fengjiexiong@126.com
Contact: Tianqi Zhu, MD 0028-13986295423 zhutianqi84@163.com

Locations
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China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital

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Responsible Party: Tongji Hospital
ClinicalTrials.gov Identifier: NCT03712657     History of Changes
Other Study ID Numbers: TJH
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent review panel. requestors will be required to sign a data access agreement.
URL: http://bethesda.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tongji Hospital:
ERAS
Pediatric surgery
Emergency
Both of systolic and diastolic will be measured

Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases