Appendicitis
Conditions
Interventions
After allocating the research subjects in the intervention group (176 patients) or group in comparison (176 patients), a standard form will be applied with filling in the identification data and preop
Sponsors
Instituto de Medicina Integral Professor Fernando Figueira
Hospital da restauração
Eligibility
Age
No minimum to 13 Years
Inclusion criteria
Inclusion criteria: Patients under 14 years of age; patients admitted with a diagnosis of acute appendicitis and indication for appendectomy at Hospital da Restauração; exclusive antibiotic therapy with Metronidazole and gentamicin with an interval between the start of the antibiotic and the appendectomy of less than 24 hours; absence of associated infection
Exclusion criteria
Exclusion criteria: Immunocompromised patients; pregnancy; previous history of hypersensitivity, reaction, or allergy to metronidazole or gentamicin; patient with severe clinical picture: septic shock, preexisting severe comorbidity that influences (ASA III) postoperative recovery; after randomization, the patient will be excluded if: patients who present an allergic reaction to the administration of metronidazole or gentamicin; appendectomy without diagnostic confirmation during surgery; inadequate infectious source control in the surgeon's opinion; patients who strictly and exclusively adhere to one of the groups cannot be guaranteed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that antibiotic prophylaxis in unperforated appendicitis with metronidazole 30mg/kg/dose and gentamicin 5mg/kg/dose in a single dose (intervention group - IG) is not inferior to prophylaxis with metronidazole 10mg/kg/dose and gentamicin 5mg/kg/dose in a single dose (comparison group – CG) in pediatric patients, using a non-inferiority margin of 15% for the frequency of intra-abdominal abscess and surgical wound infection within a period of up to 30 days after hospital discharge. Antibiotic prophylaxis or Antibiotic prophylaxis refers to the use of antibiotics to reduce the infectious complications of appendicitis, used before surgery and suspended after non perforated appendicitis is found. Perforated appendicitis will be characterized by the presence of a hole in the appendix or a fecalitis in the abdomen observed at the time of surgery. The definition will be our criterion for dividing patients in perforated and non-perforated appendicitis, and determination of postoperative management. Intra-abdominal abscess is defined as an infection that involves the abdominal part of the body deeper than the fascial/muscular layers that are opened or manipulated during the surgical procedure. It can be diagnosed by imaging or during reintervention, by purulent drainage from a drain placed in the peritoneal cavity, or isolation of organisms from a collection culture. Corresponds to the presence of infectious complication of acute appendicitis after appendectomy; If present, specify it as pelvic, subphrenic and intraperitoneal abscesses, appendicular stump abscess. Surgical wound infection corresponds to the presence of an infectious complication in surgical access after appendectomy; It can be deep or superficial, involving the skin, subcutaneous tissue and/or deep soft tissue of the incision. If present, specify it as major - significant amounts of pus with spontaneous drainage or needing a procedure to drain it. The patient may have systemic signs such as tach | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of the therapeutic scheme regarding infectious outcomes (operative wound infection and intra-abdominal abscess) after perforated appendectomy considering a non-inferiority margin of 15%. ;To determine the effectiveness of antibiotic prophylaxis in terms of infectious outcomes (operative wound infection and intra-abdominal abscess) after non-perforated appendectomy considering a non-inferiority margin of 15%.;To compare postoperative complications during hospitalization and follow-up up to 30 days after hospital discharge between study groups. Considering postoperative complications those present after appendectomy, specified as wound infection, abscesses, fecal fistula, intestinal obstruction, intussusception, hemorrhage, incisional hernia, pylephlebitis, others. Presented in absolute numbers and percentages. Complications will also be classified according to the Clavien-Dindo classification of surgical complications.;To describe additional procedures performed during hospitalization and follow-up within 30 days after hospital discharge between study groups. Considering the performance of an abdominal surgical procedure for treatment of a complication associated with acute appendicitis after appendectomy. Presented in absolute numbers and percentages.;To compare frequency of therapeutic failure between study groups. Treatment failure was defined as insufficient control of the source of intra-abdominal infection (clinical signs, fever, elevated C-reactive protein), persistence of an intra-abdominal abscess after 10 days of effective antibiotic therapy, or an inadequate antimicrobial spectrum of the drug prescribed.;To compare the incidence of acute kidney injury associated with the use of gentamicin in the perforated appendicitis between the intervention and comparison groups. Acute kidney injury will be assessed using the KDIGO criteria and the glomerular filtration rate will be calculated using the Schwartz formula by measuring serum | — |
Countries
Brazil
Contacts
Public ContactArthur Aguiar
Instituto de Medicina Integral Professor Fernando Figueira
Outcome results
None listed