Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (APPAC)

May 2, 2018 updated by: Paulina Salminen, Turku University Hospital

Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.

The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland
        • Keski-Suomi Central Hosptal
      • Mikkeli, Finland
        • Mikkeli Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Seinäjoki, Finland
        • Seinäjoki Central Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range from 18 to 60 years
  • CT scan diagnosed uncomplicated acute appendicitis

Exclusion Criteria:

  • Age under 18 years or age over 60 years
  • Pregnancy or breast-feeding
  • Allergy to contrast media or iodine
  • Renal insufficiency
  • metformin medication (DM)
  • Peritonitis (a perforated appendix)
  • Lack of co-operation (unable to give consent)
  • A severe other medical condition
  • CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Operative treatment
Regular open appendicectomy
Procedure: Appendicectomy
Standard appendicectomy
Active Comparator: Antibiotic treatment
Ertapenem 1 g i.v. x 1 three days
Drug: Ertapenem
ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
Time Frame: Up to 10 years
A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
Time Frame: 1 year
1 year
The Direct and Indirect Costs of Both Treatment Arms
Time Frame: 1 year
1 year
The Recurrence of Conservatively Treated Appendicitis
Time Frame: up to 10 years
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Oulu University Hospital
Seinajoki Central Hospital
Tampere University Hospital
Jyväskylä Central Hospital
Mikkeli Central Hospital

Investigators

  • Principal Investigator: Paulina Salminen, MD, PhD, Department of surgery, Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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