Acute Appendicitis: Active Observation With and Without Antibiotics
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Appendicitis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Selected patients with assumed uncomplicated acute appendicitis are allocated to groups "Active observation" or "Antibiotic treatment" in a 1:1 ratio.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03985514
- Collaborators
- Vastra Gotaland Region
- Investigators
- Principal Investigator: Kent Lundholm, Professor Göteborg University