Acute Appendicitis: Active Observation With and Without Antibiotics

Overview

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.

Full Title of Study: “Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

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

  • 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

Arms, Groups and Cohorts

  • 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.
  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with no symptom relief
    • Time Frame: 48 hours
    • No symptom relief and surgery is deemed necessary.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Göteborg University
  • Collaborator
    • Vastra Gotaland Region
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kent Lundholm, Professor, Principal Investigator, Göteborg University
  • Overall Contact(s)
    • Lundholm, +46-313421000, kent.lundholm@surgery.gu.se

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