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

NCT ID: NCT05095987

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-02

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Appendicitis Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective nonrandomized cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One day discharge after laparoscopic Appendectomy

Group Type EXPERIMENTAL

Laparoscopic Appendectomy

Intervention Type PROCEDURE

Laparoscopic Appendectomy for acute uncomplicated appendicitis in children

Interventions

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Laparoscopic Appendectomy

Laparoscopic Appendectomy for acute uncomplicated appendicitis in children

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miro Jukić

OTHER

Sponsor Role lead

Responsible Party

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Miro Jukić

MD, PhD, attending Pediatric Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Miro Jukić, MD, PHD

Role: STUDY_DIRECTOR

University Hospital of Split

Locations

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University hospital of Split

Split, Split-Dalmatia County, Croatia

Site Status

Countries

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Croatia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UHSplitpedsurg

Identifier Type: -

Identifier Source: org_study_id

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