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Completed

NCT Number: NCT03712657

ERAS for Pediatric Acute Appendicitis

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.

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Key information

Conditions

Pediatric Disorder Complicated Appendicitis Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS

Combination Product
  • 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.

Primary outcomes

  1. length of stay

    Time frame: through study completion, an average of 7 days

    less hospital length of stay

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Feng Jiexiong

Other

Registry information

Official study title

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

Acronym: EPAA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2018
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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