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Clinical Trials/NCT05095987
NCT05095987CompletedNot Applicable

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

Miro Jukić1 site in 1 country180 target enrollmentStarted: October 2, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
Safety of one day discharge after laparoscopic Appendectomy

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

One day discharge after laparoscopic Appendectomy

Experimental

Intervention: Laparoscopic Appendectomy (Procedure)

Outcomes

Primary Outcomes

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

  • Parental Satisfaction(1 week)

Investigators

Sponsor
Miro Jukić
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Miro Jukić

MD, PhD, attending Pediatric Surgeon

University Hospital of Split

Study Sites (1)

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