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Acute Appendicitis: Active Observation With and Without Antibiotics

Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03985514
Enrollment
126
Registered
2019-06-13
Start date
2018-05-15
Completion date
2022-06-30
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Brief summary

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.

Detailed 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.

Interventions

DRUGAntibiotic 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.

OTHERActive observation

In-hospital observation without antibiotics

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Selected patients with assumed uncomplicated acute appendicitis are allocated to groups Active observation or Antibiotic treatment in a 1:1 ratio.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with no symptom relief48 hoursNo symptom relief and surgery is deemed necessary.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026