Acute Appendicitis: Active Observation With and Without Antibiotics

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

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 413 45
    • Department of Surgery, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Flagyl; Piperacillin/Tazobactam; Ciprofloxacin
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.	Other: Active observation; In-hospital observation without antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with no symptom relief	No symptom relief and surgery is deemed necessary.	48 hours

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region
• Investigators: Principal Investigator: Kent Lundholm, Professor, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antitubercular Agents; Cytochrome P-450 CYP1A2 Inhibitors; beta-Lactamase Inhibitors; Metronidazole; Anti-Bacterial Agents; Antibiotics, Antitubercular; Ciprofloxacin; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: App 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No