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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 : June 28, 2018
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
Enrollment 530
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Appendectomy Antibiotic Therapy
Hide Arm/Group Description Open appendectomy 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.
Period Title: Overall Study
Started 273 257
Completed 272 242
Not Completed 1 15
Arm/Group Title Operative Treatment Antibiotic Treatment Total
Hide Arm/Group Description

Regular open appendicectomy

Appendicectomy: Standard appendicectomy

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 of all reporting groups
Overall Number of Baseline Participants 273 257 530
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 273 participants 257 participants 530 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 273 participants 257 participants 530 participants
Female 99 102 201
Male 174 155 329
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 273 participants 257 participants 530 participants
273 257 530
1.Primary Outcome
Title The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
Hide Description A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treatment success
Arm/Group Title Appendectomy Antibiotic Therapy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 273 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of successful treatment
99.6
(98.0 to 100.0)
72.7
(66.8 to 78.0)
2.Secondary Outcome
Title The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Direct and Indirect Costs of Both Treatment Arms
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Recurrence of Conservatively Treated Appendicitis
Hide Description [Not Specified]
Time Frame up to 10 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Appendectomy Antibiotic Therapy
Hide Arm/Group Description Open appendectomy 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
All-Cause Mortality
Appendectomy Antibiotic Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Appendectomy Antibiotic Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/273 (0.00%)   0/257 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Appendectomy Antibiotic Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   45/273 (16.48%)   6/257 (2.33%) 
Infections and infestations     
Overall morbidity  45/273 (16.48%)  6/257 (2.33%) 
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
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: June 28, 2018