Acute complex appendicitis
Conditions
Interventions
Interventions: Subgroup 1: Laparoscopic appendectomy Subgroup 2: Non-operative treatment (consisting of intravenous antibiotics with or without (percutaneous) drainage procedure) Usual care/comparison
Sponsors
Amsterdam UMC
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Eligible for inclusion are all children <18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined criteria: - 4 or more points on our scoring system developed to predict complex appendicitis. This scoring system consists of five variables (clinical, biochemical and radiological, each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are: - Diffuse abdominal guarding (3 points) - CRP level more than 38 mg/L (2 points) - Signs on ultrasound / imaging indicative for complex appendicitis (2 points) - More than one day abdominal pain (2 points) - Temperature more than 37.5 degrees Celsius (1 point) Or - High index of suspicion of complex appendicitis by the treating physician. If this is the case, the treating physician will make pre-treatment note upon what clinical, biochemical or radiological variable the high index of suspicion is based. Classification into the two subgroups of complex appendicitis will be based upon clinical and radiological features. If signs suggestive of perforated appendicitis AND intra-abdominal abscesses or enlarged mass formation are present, patients will be categorized as subgroup 2. If no abscess or enlarged mass is present on clinical exam and/or additional imaging, patients will be categorized as subgroup 1.
Exclusion criteria
Exclusion criteria: 1. Adult patients (=18 years old) 2. Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients experiencing any complication within 3 months after inclusion. All complications / events will be recorded and scored according to the Clavien-Dindo scale. The following events will be considered as complications but this list is not exhaustive: - Superficial Site infection: Criteria according to the CDC guidelines - Intra-abdominal abscess: Radiologically confirmed fluid collection containing pus or infected material that is surrounded by inflamed tissue. - Stump leakage / stump appendicitis: Radiologically confirmed intra-abdominal fluid collections after appendectomy / recurrence of disease after appendectomy. - Secondary / Prolonged bowel obstruction (including paralytic ileus): Patient requiring gastro-intestinal decompression with a nasogastric tube. - Anesthesia related complications (such as pneumonia) - Operation / trocar site hernia: Clinically confirmed by a resident or surgeon. - Need for additional surgical or radiological interventions related to primary disease (appendicitis) - Recurrent appendicitis: recurrence of disease within 3 months time after inclusion. - Re-admission for an indication related to appendicitis (such as readmissions for observation of fever and abdominal pain) All complications and their subsequent treatment will be registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients experiencing overall complications during admission (patient-level) - Proportion of patients experiencing overall complications within 30 days (patient-level) - Proportion of patients with a PAA within 3 months after inclusion (patient-level) - Proportion of patients with an SSI within 3 months after inclusion (patient-level) - Proportion of patients with a secondary/prolonged bowel obstruction within 3 months after inclusion (patient-level) - Number of days absent from school, social or sport events within 3 months after inclusion (patient-level) - Number of days absent from work within 3 months after inclusion (parents-level) - Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioner’s office or emergency department for abdominal pain within 3 months after inclusion. - Total length of hospital stay during follow-up period for strategy related treatment or complications. - Level of pain during admission (measured by the validated Visual Analogue Scale) - Pain medication utilization during admission - Proportion of patients not having to undergo appendectomy within 3 months after inclusion (subgroup 2 specifically) - Proportion of patients experiencing recurrent appendicitis within 3 months after inclusion. (subgroup 2 specifically) - Recurrent appendicitis is defined as those patients with a clinical and radiological high suspicion of recurrent appendicitis who undergo an appendectomy and histopathological examination confirms the diagnosis of recurrent appendicitis - Proportion of patients experiencing early failure of initial non-operative treatment. (subgroup 2 specifically) Early failure is defined as all patients that undergo an appendectomy during the antibiotic course (iv or oral) due to persistent complaints, clinical deterioration or faecolith. - Proportion of patients that undergo interval appendectomy within 3 months after inclusion. (subgroup 2 specifically) Interval appendecto | — |
Contacts
Public ContactPaul van Amstel
Emma Children's Hospital, Amsterdam UMC, Academisch Medisch Centrum & VU medisch centrum, Amsterdam, the Netherlands
Outcome results
None listed