Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (APPAC)
Primary Purpose
Acute Appendicitis
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Appendicectomy
Ertapenem
Sponsored by
About this trial
This is an interventional treatment trial for Acute Appendicitis
Eligibility Criteria
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
Sites / Locations
- Keski-Suomi Central Hosptal
- Mikkeli Central Hospital
- Oulu University Hospital
- Seinäjoki Central Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Operative treatment
Antibiotic treatment
Arm Description
Regular open appendicectomy
Ertapenem 1 g i.v. x 1 three days
Outcomes
Primary Outcome Measures
The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Secondary Outcome Measures
The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
The Direct and Indirect Costs of Both Treatment Arms
The Recurrence of Conservatively Treated Appendicitis
Full Information
NCT ID
NCT01022567
First Posted
November 30, 2009
Last Updated
May 2, 2018
Sponsor
Turku University Hospital
Collaborators
Oulu University Hospital, Tampere University Hospital, Mikkeli Central Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01022567
Brief Title
Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
Acronym
APPAC
Official Title
Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Oulu University Hospital, Tampere University Hospital, Mikkeli Central Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
Regular open appendicectomy
Arm Title
Antibiotic treatment
Arm Type
Active Comparator
Arm Description
Ertapenem 1 g i.v. x 1 three days
Intervention Type
Procedure
Intervention Name(s)
Appendicectomy
Intervention Description
Standard appendicectomy
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
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 Measure Information:
Title
The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
Description
A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
Time Frame
1 year
Title
The Direct and Indirect Costs of Both Treatment Arms
Time Frame
1 year
Title
The Recurrence of Conservatively Treated Appendicitis
Time Frame
up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Salminen, MD, PhD
Organizational Affiliation
Department of surgery, Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keski-Suomi Central Hosptal
City
Jyväskylä
Country
Finland
Facility Name
Mikkeli Central Hospital
City
Mikkeli
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23394263
Citation
Paajanen H, Gronroos JM, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Dean K, Jartti A, Mecklin JP, Sand J, Salminen P. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial). BMC Surg. 2013 Feb 8;13:3. doi: 10.1186/1471-2482-13-3.
Results Reference
background
PubMed Identifier
26080338
Citation
Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.
Results Reference
result
PubMed Identifier
32074268
Citation
Sippola S, Haijanen J, Viinikainen L, Gronroos J, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Jartti A, Salminen P. Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):283-289. doi: 10.1001/jamasurg.2019.6028.
Results Reference
derived
PubMed Identifier
30264120
Citation
Salminen P, Tuominen R, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Virtanen J, Jartti A, Gronroos JM. Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1259-1265. doi: 10.1001/jama.2018.13201. Erratum In: JAMA. 2018 Oct 23;320(16):1711.
Results Reference
derived
PubMed Identifier
28591824
Citation
Niiniviita H, Salminen P, Gronroos JM, Rinta-Kiikka I, Hurme S, Kiljunen T, Kulmala J, Teras M, Sippola S, Virtanen J. LOW-DOSE CT PROTOCOL OPTIMIZATION FOR THE ASSESSMENT OF ACUTE APPENDICITIS: THE OPTICAP PHANTOM STUDY. Radiat Prot Dosimetry. 2018 Jan 1;178(1):20-28. doi: 10.1093/rpd/ncx070.
Results Reference
derived
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Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
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