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Completed

NCT Number: NCT05095987

Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.

The aim of this study was to evaluate the value and safety of discharge of a child to home care within 24 hours after laparoscopic appendectomy for uncomplicated appendicitis to reduce the impact on the child's psyche and need for hospitalisation. Baseline demographic data and intraoperative finding will be recorded. Parents are given a two-page questionnaire that is completed in three cycles (immediately after discharge, daily until the first control and immediately before the first control). All data will be statistically processed using descriptive statistics.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

About this study

The research would include children who underwent laparoscopic surgery due to uncomplicated acute appendicitis in the period from October 2021 to October 2023 at the Clinic for Pediatric Surgery of the University Hospital Center Split. After the suspicion of acute inflammation of the appendix is established, the pediatric surgeon decides on surgical treatment. Recently, laparoscopic appendectomy has been performed in a standardized manner at the Clinic for Pediatric Surgery of the Clinical Hospital Center Split. After the operation, and in the current practice, the children would stay in hospital for 2 to 4 days. As the generally known psychological aspects of changes in children's behaviour in involuntary hospital stays, and now even more pronounced due to the SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) COVID19 virus pandemic and reduced opportunities for parents to stay with children, the main goal of this study is to evaluate and possibly reduce hospital stay to a minimum and proof that there are no complications in treatment outcomes due to shortening the length of hospital treatment. To conduct this research, parents are given a two-page questionnaire that is completed in three cycles (immediately after discharge, daily until the first control and immediately before the first control). Baseline demographic data and intraoperative findings will be recorded. All data will be statistically processed using descriptive statistics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children 6 to 18 years
  • uncomplicated acute appendicitis treated with laparoscopic approach
  • children released within 24 hours

Exclusion criteria

  • children under 6 years
  • complicated acute appendicitis
  • intraoperative complication
  • operated by classical approach
  • children needing longer hospital care and parental therapy
  • children with significant comorbidities that could affect treatment outcomes

Treatment and study plan

laparoscopic appendectomy

Procedure

Laparoscopic Appendectomy for acute uncomplicated appendicitis in children

Primary outcomes

  1. Safety of one day discharge after laparoscopic Appendectomy

    Time frame: 4 weeks

    Safety of one day discharge after laparoscopic appendectomy for uncomplicated acute appendicitis in children.

    It will be measured by readmission rate of the "early" discharged children (within 24 hours from surgery). If there is no readmissions then the one day discharge after laparoscopic appendectomy for uncomplicated acute appendicitis in children would be considered safe. Again, the condition of an operated child is monitored and followed-up in an outpatient clinic 1 week after the surgery. The parental notes, and observations are taken into account.

Secondary outcomes

  1. Parental Satisfaction

    Time frame: 1 week

    Using a questionnaire to evaluate parental satisfaction. There are four parts of the questionnaire: First part of the questionnaire 3 level scoring in satisfaction in agreeing of one day discharge after the surgery (the very first day), second part is structured as a simple yes/no answer possibility of childs behaviour and pain at home. The third part is a child pain score from 0-10, 0 being no pain and 10 greatest unbearable pain and parental-child pain management (used medicine, etc...). Finally, fourth part is modified first part where there is 3 level scoring in satisfaction in agreeing of one day discharge after the surgery, but now one week after.

Other outcomes

  1. Readmission rate

    Time frame: 2 weeks

    Readmission rate to the hospital due to the laparoscopic appendectomy.

  2. Complication rate

    Time frame: 2 weeks

    Complication due to surgical intervention

  3. Cost reduction

    Time frame: 2 weeks

    due to shorter hospital stay the study anticipates a cost reduction

Sponsors and collaborators

Lead sponsor

Miro Jukić

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2021
Registry last updated
Jul 20, 2022

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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