Acute Appendicitis: Active Observation With and Without Antibiotics

Göteborg University

Status and phase: Completed; Phase 4

Conditions: Appendicitis

Treatments: Drug: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).; Other: Active observation

Study type: Interventional

Funder types: Other

Identifiers

NCT03985514

App 2018

Details and patient eligibility

About

This study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.

Full description

Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence.

However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective.

The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.

Enrollment: 126 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with suspected appendicitis.
• Age<60 years.
• C-reactive protein < 60 mg/L.
• White blod cell Count (leucocytes) < 13 e9 /L.

Exclusion criteria

• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Antibiotic treatment

Active Comparator group

Description:

Patients will receive in-hospital intravenous antibiotics (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Surgery if no symptom relif occur.

Treatment:

Drug: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).

Clinical observation

Other group

Description:

Patients are followed by in-hospital "Active observation" (watchful waiting) according to clinical routine. Patients are observed until either, recovery and dismissal from hospital, or decision for intervention (surgery) is taken.

Treatment:

Other: Active observation