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

Not Applicable

Completed

• Conditions: Appendicitis Acute
• Interventions: Procedure: Laparoscopic Appendectomy

• Registration Number: NCT05095987
• Lead Sponsor: Miro Jukić

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-10-01
• Study Start: 2021-10-02
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-27
• Primary Completion: 2022-06-01
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One day discharge after laparoscopic Appendectomy	Laparoscopic Appendectomy	-

Primary Outcome Measures

Name	Time	Method
Safety of one day discharge after laparoscopic Appendectomy	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 Outcome Measures

Name	Time	Method
Parental Satisfaction	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.

Trial Locations

Locations (1)

University hospital of Split; 🇭🇷 Split, Splitsko Dalmatinska Županija, Croatia