Acute Appendicitis: Active Observation With and Without Antibiotics
NCT ID: NCT03985514
Last Updated: 2022-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
126 participants
INTERVENTIONAL
2018-05-15
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Clinical observation
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.
Active observation
In-hospital observation without antibiotics
Interventions
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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.
Active observation
In-hospital observation without antibiotics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age\<60 years.
* C-reactive protein \< 60 mg/L.
* White blod cell Count (leucocytes) \< 13 e9 /L.
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Kent Lundholm, Professor
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Department of surgery, Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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App 2018
Identifier Type: -
Identifier Source: org_study_id
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