Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.
Primary Purpose
Appendicitis Acute
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Laparoscopic Appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis Acute focused on measuring Pediatric Surgery, One day discharge, parental satisfaction questionnaire, laparoscopic appendectomy
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
Sites / Locations
- University hospital of Split
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One day discharge after laparoscopic Appendectomy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05095987
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miro Jukić
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
Keywords
Pediatric Surgery, One day discharge, parental satisfaction questionnaire, laparoscopic appendectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective nonrandomized cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One day discharge after laparoscopic Appendectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Appendectomy
Intervention Description
Laparoscopic Appendectomy for acute uncomplicated appendicitis in children
Primary Outcome Measure Information:
Title
Safety of one day discharge after laparoscopic Appendectomy
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Parental Satisfaction
Description
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.
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Readmission rate
Description
Readmission rate to the hospital due to the laparoscopic appendectomy.
Time Frame
2 weeks
Title
Complication rate
Description
Complication due to surgical intervention
Time Frame
2 weeks
Title
Cost reduction
Description
due to shorter hospital stay the study anticipates a cost reduction
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miro Jukić, MD, PHD
Organizational Affiliation
University Hospital of Split
Official's Role
Study Director
Facility Information:
Facility Name
University hospital of Split
City
Split
State/Province
Splitsko Dalmatinska Županija
ZIP/Postal Code
21000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.
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