Clinical trial NCT05095987: Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.
Official title: Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis Acute
Keywords: Pediatric Surgery
One day discharge
parental satisfaction questionnaire
laparoscopic appendectomy
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective nonrandomized cohort study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of one day discharge after laparoscopic Appendectomy
timeFrame: 4 weeks
Secondary outcomes:
measure: Parental Satisfaction
timeFrame: 1 week
Other outcomes:
measure: Readmission rate
timeFrame: 2 weeks
measure: Complication rate
timeFrame: 2 weeks
measure: Cost reduction
timeFrame: 2 weeks
Locations:
city: Split
country: Croatia
facility: University hospital of Split
state: Splitsko Dalmatinska Županija
Study officials:
affiliation: University Hospital of Split
name: Miro Jukić, MD, PHD
role: STUDY_DIRECTOR
References: