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NCT Number: NCT03985514

Acute Appendicitis: Active Observation With and Without Antibiotics

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.

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Key information

Conditions

Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of surgery, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Drug

Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.

Other names: Piperacillin/Tazobactam, Ciprofloxacin, Flagyl

Active observation

Other

In-hospital observation without antibiotics

Primary outcomes

  1. Number of participants with no symptom relief

    Time frame: 48 hours

    No symptom relief and surgery is deemed necessary.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 13, 2019
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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