No registrations found.
ID
Source
Health condition
Appendicitis
children
Antibiotic treatment
Non-operative treatment
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety of initial antibiotic treatment defined as:
Occurrence of major complications, such as:
A. Anaphylactic shock and other allergic reaction to antibiotics administered
b. Recurrent appendicitis within 8 weeks
c. Recurrent appendicitis within one year after discharge
d. Development of perforated appendicitis
e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention
f. Re-admission
g. Re-intervention other than delayed appendectomy
Secondary outcome
Major complications associated with appendectomy
a. Stumpleakage
b. Intra-abdominal abscess (IAA)
c. Secondary bowel obstruction (SBO)
d. Superficial site infection (SSI)
e. Need for secondary operation
f. Need for other re-intervention
g. Re-admission
h. Anaesthesia related complication
i. Pneumonia
Background summary
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:
Primary research question:
What is the complication rate of the initial antibiotic treatment strategy (IATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Secondary research question:
What is the complication rate of the direct appendectomy treatment strategy (DATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Study objective
N/A
Study design
1. Short term (1 month);
2. Long term (1 year).
A QOLquestionaire will be used for measurements.
Intervention
Initial antibiotic treatment strategy (IATS): Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) and gentamicin 7mg/kg once daily will be given for 48 hours. If possible the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days. If after 72 hours, the patient does not meet the predefined criteria, an appendectomy will be performed.
R.R. Gorter
Amsterdam
The Netherlands
+31 (0)20 4444444
rr.gorter@vumc.nl
R.R. Gorter
Amsterdam
The Netherlands
+31 (0)20 4444444
rr.gorter@vumc.nl
Inclusion criteria
• Age 7-17 years
• Radiologically confirmed simple appendicitis, defined as:
a. Clinical findings:
i. Unwell, but not generally ill
ii. Localized tenderness in the right iliac fossa region
iii. Normal/hyperactive bowel sounds
iv. No guarding
v. No mass palpable
b. Ultrasonography (see appendix 13.13):
i. Incompressible appendix with an outer diameter of ≥6 mm
ii. Hyperaemia within the appendiceal wall
iii. Without faecolith
iv. Infiltration of surrounding fat
v. No signs of perforation
vi. No signs of intra-abdominal abscess/phlegmone
Exclusion criteria
1. Patients with severe general illness at time of presentation:
a. Generalized peritonitis defined as:
Diffuse inflammation of the peritoneum with clinical signs consisting of increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity, sinus tachycardia, signs of paralytic ileus
b. Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [38]. (appendix 13.6)
c. Signs of complex appendicitis
2. Children with a faecolith on ultrasonography.
3. Patients with serious associated conditions or malformations such as:
a. Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
b. Immunodeficiency
c. Malignancy
d. Homozygous sickle cell disease
e. Metabolic disorders
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2681 |
| NTR-old | NTR2810 |
| Other | Kinderchirurgisch Centrum Amsterdam : KCA2011 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |