K35.8
Conditions
Interventions
Group 1: Intervention: oral antibiotic therapy of uncomplicated acute appendicitis in children between the ages of 6 and 18. The follow up is performed through a telemedicine app and fixed appointment
Sponsors
Univ. Klinik für Kinder und Jugendchirurgie, Medizinische Universität Wien, Wien, Österreich
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: - patients between 6-18 years of age - sonographically diagnosed non-complicated acute appendicitis: absence of pericecal fluid, or abscess, prominent pericecal fat inflammation and absence of appendicolith. - under written consent
Exclusion criteria
Exclusion criteria: - patients < 6 years of age - sonographically diagnosed complicated acute appendicitis: loculated pericecal fluid or absess, prominent pericecal fat inflammation and circumferential loss of the submucosal layer - presence of appedicolith - major comorbities or previous abdominal operations - out-patient clinic management not possible (uncompliace of patient and/or family) - oral antibiotic therapy not possible - absence of written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the success rate of non-operative management of non-complicated acute appendicitis in children treated with oral antibiotics in an out-patient clinical setting in comparison to early appendectomy. The primary outcome will be analysed on a non-inferiority basis using a 20% non inferiority margin. The outcomes will be evaluated 1 year after inclusion in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The patients and their parents will receive a questionnaire at the end of the study period. Each question can be answered with the following multiple choice options: 1. strongly disagree 2. disagree 3. niether agree nor disagree 4. agree 5 strongly agree • Healthcare satisfaction • satisfaction with decision making measures • Rates of complicated appendicitis: The proportion of patients with complicated appendicitis, as identified during appendectomy with either visualization of a hole in the appendix, extramural appendicolith, frank pus in the abdomen, or pathologic findings of transmural inflammation with perforation through the wall of the appendix, will be compared between the non-operative group (identified during appendectomy in those that fail non-operative management) and in the surgery group. This outcome compares the risk of a patient having more severe or worse appendicitis if they choose non-operative management vs. surgery. • Rates of post-treatment related complications/ Post-treatment related complications includes: episodes of symptoms (e.g. pain, nausea/emesis) requiring unplanned physician or Emergency Department visits or hospital admission and additional surgical or interventional procedures. The proportion of these complications will be compared between treatment groups. This outcome assesses differences in medical morbidity between the treatment groups which is necessary to provide patients and families with a complete risk-benefit assessment of each treatment option. • hospital length of stay • total days off school and days off work for the parents: total number of days in which the patients and the families missed school or work during or after the therapy will be analyzed and compared between the two groups. • recurrence • Days to pain-relief (VAS=0) • Costs for the health system: The costs for the health system will be analyzed for both groups and compared. | — |
Countries
Austria
Contacts
Public ContactRenate Fartacek
Univ. Klinik für Kinder und Jugendchirurgie, Medizinische Universität Wien
Outcome results
None listed