Randomized trial of Alvarado score and antibiotics therapy as a corporate protocol versus conventional clinical management for acute appendicitis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: The patients will be randomized according to a computer‐generated randomization list into case and control group. The Alvarado score is calculated for both groups by a general practitioner not involved in other stages of the study. The Alvarado scores of the patients in the control group will not be known to the admitting service and surgical team. They will continue with conventional clinical assessment and management. The admitting service and the surgical team are informed of the Alvarado scores of patients in the case group. Afterward, patients of the case group will be divided into 3 management subgroups according to their own Alvarado scores: Subgroup 1 ‐ Alvarado score 4 or less. Discharge, no follow up. Subgroup 2 ‐ Alvarado score 5 to 7. Outpatient antibiotics and observation if practicable. They will be prescribed one dose of intravenous gentamicin, 6 mg/kg, and metronidazole, 500 mg for adults or 15 mg/kg as a loading dose for children. Afterward, patients will be discharged on a 10‐day course of co‐amoxiclav 625 tablets 3 times daily for adults and oral suspension of co‐amoxiclav 312.5, 25 mg/kg per day in divided doses every 8 hours for children (Farabi Pharmaceutical Co, Iran). They will be asked to attend 1 day in the clinic. Subgroup 3 ‐ Alvarado score 8 to 10. Immediate operation. They will be immediately arranged to undergo emergency surgery after intravenous injection of antibiotics loading dose as mentioned above. CONDITION: Acute appendicitis ; Digestive System ; Acute appendicitis PRIMARY OUTCOME: 1. Time to surgery, from randomization to skin preparation in hours; 2. Duration of hospitalization, from randomization to discharge from hospital or emergency service (for out‐patients) in hours SECONDARY OUTCOME: 1. Admission rate; 2. Operation rate; 3. Nontherapeutic surgeries rate (surgery is called therapeutic when it finds the cause of patient?s pain and it is pertinent to cure the problem); 4. Perforation with late treatment (PLT) rate (treatment that begins at least 10 hours after randomization is considered late) INCLUSION CRITERIA: 1. Older than 6 years 2. Admitted initially for the current abdominal pain
Epistemonikos ID: 3ad14e5e30cd85c94670154d2c7b244d36acf925
First added on: Aug 21, 2024