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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01022567
Recruitment Status : Active, not recruiting
First Posted : December 1, 2009
Results First Posted : February 23, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Appendicitis
Interventions: Procedure: Appendicectomy
Drug: Ertapenem

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Appendectomy Open appendectomy
Antibiotic Therapy Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.

Participant Flow:   Overall Study
    Appendectomy   Antibiotic Therapy
STARTED   273   257 
COMPLETED   272   242 
NOT COMPLETED   1   15 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Operative Treatment

Regular open appendicectomy

Appendicectomy: Standard appendicectomy

Antibiotic Treatment

Ertapenem 1 g i.v. x 1 three days

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.

Total Total of all reporting groups

Baseline Measures
   Operative Treatment   Antibiotic Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 273   257   530 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      273 100.0%      257 100.0%      530 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex/Gender, Customized 
[Units: Participants]
     
Female   99   102   201 
Male   174   155   329 
Region of Enrollment 
[Units: Participants]
     
Finland   273   257   530 


  Outcome Measures

1.  Primary:   The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis   [ Time Frame: Up to 10 years ]

2.  Secondary:   The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   The Direct and Indirect Costs of Both Treatment Arms   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   08/2017  

4.  Secondary:   The Recurrence of Conservatively Treated Appendicitis   [ Time Frame: up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   06/2022  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paulina Salminen
Organization: Turku University Hospital
phone: +358 2 313 0542
e-mail: paulina.salminen@tyks.fi


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paulina Salminen, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01022567     History of Changes
Other Study ID Numbers: APPAC
First Submitted: November 30, 2009
First Posted: December 1, 2009
Results First Submitted: August 21, 2016
Results First Posted: February 23, 2017
Last Update Posted: August 25, 2017