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Trial record 1 of 1 for:    01022567
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Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (APPAC)

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ClinicalTrials.gov Identifier: NCT01022567
Recruitment Status : Active, not recruiting
First Posted : December 1, 2009
Results First Posted : February 23, 2017
Last Update Posted : June 28, 2018
Oulu University Hospital
Tampere University Hospital
Mikkeli Central Hospital
Jyväskylä Central Hospital
Seinajoki Central Hospital
Information provided by (Responsible Party):
Paulina Salminen, Turku University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Procedure: Appendicectomy Drug: Ertapenem Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Study Start Date : November 2009
Actual Primary Completion Date : June 2012
Estimated Study Completion Date : December 2025

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment [ Time Frame: 1 year ]
  2. The Direct and Indirect Costs of Both Treatment Arms [ Time Frame: 1 year ]
  3. The Recurrence of Conservatively Treated Appendicitis [ Time Frame: up to 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022567

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Keski-Suomi Central Hosptal
Jyväskylä, Finland
Mikkeli Central Hospital
Mikkeli, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Tampere University Hospital
Mikkeli Central Hospital
Jyväskylä Central Hospital
Seinajoki Central Hospital
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Principal Investigator: Paulina Salminen, MD, PhD Department of surgery, Turku University Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulina Salminen, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01022567    
Other Study ID Numbers: APPAC
First Posted: December 1, 2009    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: June 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents