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

Appendicitis Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095987
• Other study ID #: UHSplitpedsurg
• Status: Completed
• Phase: N/A
• Start date: October 2, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Procedure:
• Laparoscopic Appendectomy
Laparoscopic Appendectomy for acute uncomplicated appendicitis in children

Locations

Country	Name	City	State
Croatia	University hospital of Split	Split	Splitsko Dalmatinska Županija

Sponsors (1)

Lead Sponsor	Collaborator
Miro Jukic

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission rate	Readmission rate to the hospital due to the laparoscopic appendectomy.	2 weeks
Other	Complication rate	Complication due to surgical intervention	2 weeks
Other	Cost reduction	due to shorter hospital stay the study anticipates a cost reduction	2 weeks
Primary	Safety of one day discharge after laparoscopic Appendectomy	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.	4 weeks
Secondary	Parental Satisfaction	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.	1 week