Acute Appendicitis: Active Observation With and Without Antibiotics
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|ClinicalTrials.gov Identifier: NCT03985514|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||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||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment|
|Actual Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Active Comparator: Antibiotic treatment
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.
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).
Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.
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.
Other: Active observation
In-hospital observation without antibiotics
- Number of participants with no symptom relief [ Time Frame: 48 hours ]No symptom relief and surgery is deemed necessary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985514
|Contact: Lundholm||+46-313421000 ext firstname.lastname@example.org|
|Department of surgery, Sahlgrenska University Hospital||Recruiting|
|Göteborg, Sweden, 413 45|
|Contact: Kent Lundholm, MD, prof 46-31-342-1000 ext 4437 email@example.com|
|Principal Investigator: Kent Lundholm, MD, prof|
|Principal Investigator:||Kent Lundholm, Professor||Göteborg University|