OBJECTIVE The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications, health-related QOL and costs. Main research question: What is the difference in proportion of patients experiencing complications within 1 year between both strategies in children from 7 to 17 years old, inclusive, with acute simple appendicitis?
Initial non-operative treatment of acute simple appendicitis has recently been investigated in both the adult as the paediatric population. In the adult population, six Randomised Controlled Trial (RCTs) showed that an appendectomy could be avoided in 40-76% of the patients at the end of their follow-up period. Despite the fact that some patients need to undergo a delayed appendectomy, it has been demonstrated in systematic reviews that non-operative treatment strategy is associated with a significant reduction in complications, faster recovery and return to work, less pain duration and analgesic medication consumption. In children only pilot data is yet available. Short-term success rates of this strategy (including of the investigators own pilot cohort study) are between the 83-92%. Long-term results (one-year follow-up) are available from two studies; 62-75% did not require an appendectomy. No large RCT have yet been conducted in the paediatric population. It is therefore essential to generate high quality empirical evidence regarding this strategy in this subset of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours
Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics
Medical Center Alkmaar
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Amstelland
Amstelveen, Netherlands
AMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
VU University medical center
Amsterdam, Netherlands
Gelre Hospital
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Red Cross Hospital
Beverwijk, Netherlands
Albert Schweitzer
Dordrecht, Netherlands
...and 5 more locations
Proportion of patients experiencing complications
Time frame: One year follow up
Number of days absent from school, social or sport events
Time frame: 7 days, 1,6,12 months
Number of days absent from work
Time frame: 7 days, 1,6,12 months
Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain.
Time frame: 7 days, 1,6,12 months
Total length of hospital stay during the follow-up period for strategy related treatment or complications
Time frame: 7 days, 1,6,12 months
Total days of analgesics medication use.
Time frame: one month
Pain score measured by the Visual Analogue Scale (VAS)
Time frame: Clinical phase (up to 7 days)
Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis
Time frame: 7 days, 1,6,12 months
Proportion of patients not having to undergone appendectomy
Time frame: 7 days, 1,6,12 months
Proportion of patients experiencing recurrent appendicitis
Time frame: 7 days, 1,6,12 months
Proportion of patients experiencing early failure of initial non-operative treatment.
Time frame: 7 days, 1,6,12 months
Proportion of patients that undergo interval appendectomy.
Time frame: 7 days, 1,6,12 months
Quality of life questionnaire (CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy)
Time frame: 7 days, 1,6,12 months
Medical and non-medical costs (Health and Labor questionnaire)
Time frame: 1,6,12 months
Quality adjusted life years (QALY's). Calculating using outcome 13 and 14
Time frame: 1,6,12 months
Patient satisfaction questionnaire (PSQ-18 & Net promotor score)
Time frame: 7 days, 1,6,12 months
Promoting and obstructing factors of implementability measured by questionnaires
Time frame: 12 months
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