Acute Appendicitis: Active Observation With and Without Antibiotics

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985514
• Other study ID #: App 2018
• Status: Completed
• Phase: Phase 4
• Start date: May 15, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

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.

Other:
• Active observation
In-hospital observation without antibiotics

Locations

Country	Name	City	State
Sweden	Department of surgery, Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with no symptom relief	No symptom relief and surgery is deemed necessary.	48 hours