Non-operative Treatment of Acute Non-perforated Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Gold Standard treatment of appendicitis is appendectomy but non-operative treatment of
      non-perforated appendicitis with antibiotics is also under trial. Although appendectomy is
      curative but it is an invasive procedure done under general anesthesia with different risks
      and complications during and after operation, leading to disturbance of child daily routines
      and activities. Reported rates of perioperative complications are from 5% - 10%, with serious
      complications occurring in 1% to 7% of patients.

      Children presenting with acute (<2 days) right iliac fossa pain with pediatric appendicitis
      score >7, with none of the following on ultrasonography: abscess formation, or loss of the
      echogenic sub-mucosal layer of the appendix or presence of an appendicolith or
      periappendiceal fluid collection will be labeled as having appendicitis.

      After diagnosis we divided the patients into two groups.patients in group A will be treated
      with antibiotics and appendectomy is done for group B patients.
    

Detailed description: 
      Acute appendicitis is one of the most common presenting conditions in pediatric emergencies.
      It has an estimated lifetime risk of about 8%. Although it commonly occurs in the second
      decade of life but 11.4% children are diagnosed with acute appendicitis in the pediatric
      emergency.

      The rationale of my study is that limited local clinical trial is available regarding the
      efficacy of non-operative treatment with antibiotics vs operative treatment of acute
      non-perforated appendicitis in children.

      All children between 5 and 15 years of age of both genders admitted in the pediatric surgery
      emergency with having pediatric appendicitis score (PAS anexure 1) >7 will be included in the
      study.

      All the patients inducted in the study will be randomly divided into two groups:
      Non-operative treatment (group A) and operative treatment (group B), using computer generated
      number. Each patient will be evaluated and relevant data according to the predesigned
      questionnaire will be collected and documented. Age, duration of symptoms, body
      temperature,C-reactive protein, white blood cell, neutrophil concentrations, Ultrasound
      findings and PAS score will be noted at the time of admission. Children in non-operative
      treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and
      metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child
      starts tolerating oral intake and becomes clinically improved, the treatment will be changed
      to oral ciprofloxacin (20 mg/kg/day divided into 2 divided doses) and metronidazole (20 mg/kg
      × 1 per 24 hours) for another 8 days. Supportive care will be given equally to all the
      patients as protocol of treatment with regular vital monitoring. Improvement or development
      of complications will be noted. Discharge criteria for both groups will be: afebrile for 24
      hours, with or without oral antibiotics, adequate pain relief on oral analgesia assesd by
      visual analogue scale ( VAS) scale (anexure 2), tolerating a light diet, and mobile.

      Failure of non-operative treatment will be defined if any one of the following is seen:
      abscess formation or complex peri-appendiceal fluid collection seen on ultrasonography, the
      need for surgery (due to worsening of symptoms evaulated by history, physical examination and
      repeat ultrasonography) within 48 hours, or recurrence of appendicitis within 3 months.

      Patients with recurrence of symptoms of appendicitis (right iliac fossa pain with pediatric
      appendicitis score >7) after complete resolution previously with non-operated treatment, will
      be labeled as Recurrent appendicitis.All the data will be collected on a preformed
      questionnaire. Discharge criteria for both the groups will be: afebrile for 24 hours, with or
      without oral antibiotics, adequate pain relief on oral analgesia and tolerating a light diet.
      Patient will be kept on follow-up in group-A for duration of 3 month to 6 month. Patients
      will be kept on follow-up in Outdoor patients department once in a week till 3 months in
      group B.

      ANNEXURE 1: Pediatric Appendicitis Score (PAS)

      No Symptoms Score

        1. Right iliac fossa tenderness to cough, percussion, or hopping 2

        2. Migration of pain to Right iliac fossa 1

        3. Anorexia 1

        4. Fever (Temperature ≥38.0ºC/100.4ºF) 1

        5. Nausea or vomiting 1

        6. Tenderness over right iliac fossa 2

        7. Leukocytosis (WBC >10,000 ) 1

        8. Left shift (PMN >7,500 ) 1

      Acute Appendicitis if score is >7

      Anexure 2 Visual Analogue Scale

      0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 =Moderate pain 7-10 =Severe discomfort
      or pain or both
    

Intervention name(s): Meronem and flagyl; Appendectomy
Intervention type(s): Drug; Procedure
Intervention description(s): meronem and flagy; Appendectomy as treatment for acute appendicitis
Other intervention name(s): Flagyl
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After permission from the ethical review board (ERB), Children diagnosed with acute appendicitis and fulfilling the inclusion and exclusion criteria will be included in the study after taking informed consent from parents. All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Total sample size is 180 patiens and duration is 3 to 6 months.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Appendicitis.; Pediatric Appendicitis Score (PAS).; Visual Analogue Scale (VAS) Score.