1. What is the complication rate of the initial antibiotic treatment strategy for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
ID
Source
Brief title
Condition
- Gastrointestinal infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety of antibiotic treatment defined as:
Occurrence of major complications:
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, stump leakage, secondary bowel obstruction,
superficial site infection, need for secondary operation, need for
re-intervention other than appendectomy, re-admission, anaesthesia related
complications, pneumonia.
f. Re-admission
g. Re-intervention other than delayed appendectomy
Secondary outcome
Secondary research question:
What is the complication rate of the direct appendectomy treatment strategy for
acute simple appendicitis (radiological proven) in children aged 7-17 years
old? .
Additional research questions:
1. What is the quality of life of patients and family treated with antibiotic
treatment alone?
2. What is the quality of life of parents and family treated with
appendectomy?
2. What is the current opinion about acute appendicitis in both the medical
society as well as the general public?
3. Is failure of antibiotic treatment alone for simple appendicitis predictable
by certain clinical, laboratory parameters or radiological features?
4. What are the changes on ultrasonography of the appendix after two days of
intravenous antibiotics?
5. Is ultrasonography useful in predicting failure of antibiotic treatment
alone?
6. Can we identify risk factors of developing recurrent appendicitis within one
year?
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 more than 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
Study objective
1. What is the complication rate of the initial antibiotic treatment strategy
for acute simple appendicitis (radiological proven) in children aged 7-17 years
old?
Study design
Prospective multi-center cohort study.
Intervention
Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly
(total 100/10 mg/kg daily) 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 for in total 7 days
Patients will be admitted at least for 48 hours
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
1. Risks of participation: Need for 'secondary' operation, recurrent
appendicitis, risk of perforation. Risks that are also present in case of
non-participation: Allergic reaction to antibiotics, appendectomy associated
complications
2. Burden of participation: Admission of at least 2 days (compared
to 1-2 days with appendectomy), ultrasonography after 24 hours (extra
procedure), outpatient follow up (two extra procedure), filling out QOL
questionnaires (3x). Burden also present in case of non-participation:
Intravenous access (normal procedure), daily blood samples (normal procedure),
3. Benefit of participation: Avoidance of surgery and its related
early and late morbidity, potential better quality of life.
Burden of control group:
1. One extra out patient visit after 8 weeks
2. Filling out QOL questionnaires (3x)
3. Telephone follow up after one year.
De boelelaan 1117
Amsterdam 1081 HV
NL
De boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Written Informed consent obtained
* 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:
i. Incompressible appendix with an outer diameter of *6 mm
ii. Hyperaemia within the appendiceal wall
iii. With or without faecolith
iv. Infiltration of surrounding fat
v. No signs of perforation
vi. No signs of intra abdominal abscess/phlegmone
Exclusion criteria
The following patients will be excluded from participating in this study:
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 [36]. See attachment 1.
c. Signs of complex appendicitis;2. 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;3. Patient with documented type 1 allergy to the antibiotics used;4. Children with faecolith on ultrasound
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-004495-12-NL |
| ClinicalTrials.gov | NCT01356641 |
| CCMO | NL38141.029.11 |