Antibiotic Treatment Alone for Acute Simple Appendicitis in Children
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

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:
    

Detailed description: 
      Primary Objective:

      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 Objective:

      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 design:

      Prospective multi-centre pilot cohort study.

      Study population:

      Children (7-17years old) with radiologically proven simple appendicitis.

      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.

      Control group:

      The control group will consist of patients, who do not want the antibiotic treatment. Their
      medical files will be monitored prospectively. In addition they will be scheduled for an
      extra outpatient clinic follow up (8 weeks after discharge), extra telephone contact one year
      after discharge and asked to fill out quality of life questionnaires.

      Primary parameters/endpoints:

      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 parameters Major complications associated with appendectomy

        1. Stumpleakage

        2. Intra-abdominal abscess (IAA)

        3. Secondary bowel obstruction (SBO)

        4. Superficial site infection (SSI)

        5. Need for secondary operation

        6. Need for other re-intervention

        7. Re-admission

        8. Anaesthesia related complication

        9. Pneumonia

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness:

        1. Risks of participation: Need for delayed operation, recurrent appendicitis. Risks that
           are also present in case of non-participation: Allergic reaction to antibiotics, known
           appendectomy associated complications.

        2. Burden of participation: Extra admission day (in comparison with appendectomy),
           ultrasonography after 48 hours (extra procedure), outpatient follow up (two extra
           visits), filling out QOL questionnaires. Burden also present in case of
           non-participation: Intravenous access (normal procedure), daily blood samples (normal
           procedure). Regarding the control group, the burden will consist of an extra outpatient
           clinic follow up (8 weeks after discharge), extra telephone contact one year after
           discharge and fill out quality of life questionnaires.

        3. Benefit of participation: Avoidance of surgery and its related early and late morbidity,
           potential better quality of life.
    

Intervention name(s): Antibiotic treatment alone; Appendectomy
Intervention type(s): Drug; Procedure
Intervention description(s): Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily At least 48 hours intravenous administration, in total seven days of antibiotics Oral amoxicillin/clavulanic acid 50/12.5mg/kg; Appendectomy either open or laparoscopic depending on the surgeon's preference
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic treatment; Non perforated appendicitis; Children