Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children

Appendicitis Clinical Trial

— APAC  

Official title:

Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children Aged 7-17 Years Old - Antibiotics Versus Primary Appendectomy in Children With Simple Appendicitis: APAC Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02848820
• Other study ID #: APAC2016
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age 7-17 years

• Radiologically confirmed simple appendicitis, defined as:

1. Clinical findings:

• Unwell, but not generally ill

• Localized tenderness in the right iliac fossa region

• Normal/hyperactive bowel sounds

• No guarding

• No mass palpable

2. Ultrasonography:

• Incompressible appendix with an outer diameter of =6 mm

• Hyperaemia within the appendiceal wall

• Without faecolith

• Infiltration of surrounding fat

• No signs of perforation

• No signs of intra-abdominal abscess/phlegmon

Exclusion Criteria:

• Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system).

• Scoring system: As scoring system was developed determining the risk of complex appendicitis based upon five pre-operative variable. Points have been awarded to each variable. In case the total score is less than 4 points, the patient is likely to have a simple appendicitis. In case the score is 4 or more points, the chance of having complex appendicitis is significant and those children will be excluded from this study. Variables:

• Diffuse abdominal guarding (3 points)

• C-Reactive Protein level more than 38 mg/L (2 points)

• Signs on ultrasound indicative of complex appendicitis (2 points)

• More than one day abdominal pain (2 points)

• Temperature: more than 37.5 degree Celsius (1 point)

• Faecolith (ultrasound)

• Serious co-morbidity

• Recurrent appendicitis

• Suspicion of an underlying malignancy or inflammatory bowel disease

• Documented type 1 allergy to the antibiotics used.

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Augmentin + Gentamicin
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

Procedure:
• Appendectomy
Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar
Netherlands	Flevoziekenhuis	Almere
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	Haga ziekenhuis	Den Haag
Netherlands	Albert Schweitzer	Dordrecht
Netherlands	Maxima medical center	Eindhoven
Netherlands	Zuyderland	Heerlen
Netherlands	Antonius Hospital	Nieuwegein
Netherlands	Franciscus, Gasthuis en Vlietland	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Ramon Gorter	Amsterdam UMC, location VUmc, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing complications		One year follow up
Secondary	Number of days absent from school, social or sport events		7 days, 1,6,12 months
Secondary	Number of days absent from work		7 days, 1,6,12 months
Secondary	Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain.		7 days, 1,6,12 months
Secondary	Total length of hospital stay during the follow-up period for strategy related treatment or complications		7 days, 1,6,12 months
Secondary	Total days of analgesics medication use.		one month
Secondary	Pain score measured by the Visual Analogue Scale (VAS)		Clinical phase (up to 7 days)
Secondary	Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis		7 days, 1,6,12 months
Secondary	Proportion of patients not having to undergone appendectomy		7 days, 1,6,12 months
Secondary	Proportion of patients experiencing recurrent appendicitis		7 days, 1,6,12 months
Secondary	Proportion of patients experiencing early failure of initial non-operative treatment.		7 days, 1,6,12 months
Secondary	Proportion of patients that undergo interval appendectomy.		7 days, 1,6,12 months
Secondary	Quality of life questionnaire (CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy)		7 days, 1,6,12 months
Secondary	Medical and non-medical costs (Health and Labor questionnaire)		1,6,12 months
Secondary	Quality adjusted life years (QALY's). Calculating using outcome 13 and 14		1,6,12 months
Secondary	Patient satisfaction questionnaire (PSQ-18 & Net promotor score)		7 days, 1,6,12 months
Secondary	Promoting and obstructing factors of implementability measured by questionnaires		12 months