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

NCT05095987 | Completed

• 1 other identifier: UHSplitpedsurg
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute

Keywords

Pediatric Surgery; One day discharge; parental satisfaction questionnaire; laparoscopic appendectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parental Satisfaction

  1 week

Other Outcomes (3)

• Readmission rate

  2 weeks

• Complication rate

  2 weeks

• Cost reduction

  2 weeks

Study Arms (1)

One day discharge after laparoscopic Appendectomy

EXPERIMENTAL

Procedure: Laparoscopic Appendectomy

Interventions

Laparoscopic Appendectomy PROCEDURE

Laparoscopic Appendectomy for acute uncomplicated appendicitis in children

One day discharge after laparoscopic Appendectomy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children 6 to 18 years
• uncomplicated acute appendicitis treated with laparoscopic approach
• children released within 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Miro Jukić: lead

Study Sites (1)

University hospital of Split

Split, Split-Dalmatia County, 21000, Croatia

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Miro Jukić, MD, PHD

  University Hospital of Split

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, attending Pediatric Surgeon

Model Details: prospective nonrandomized cohort study

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 27, 2021
• Study Start: October 2, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)