Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
NCT ID: NCT01022567
Last Updated: 2018-06-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
530 participants
INTERVENTIONAL
2009-11-30
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Interventions
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Appendicectomy
Standard appendicectomy
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.
Eligibility Criteria
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Inclusion Criteria
* CT scan diagnosed uncomplicated acute appendicitis
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Oulu University Hospital
OTHER
Tampere University Hospital
OTHER
Mikkeli Central Hospital
OTHER
Jyväskylä Central Hospital
OTHER
Seinajoki Central Hospital
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Paulina Salminen
MD, PhD
Principal Investigators
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Paulina Salminen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of surgery, Turku University Hospital
Locations
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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
Countries
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References
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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.
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.
Selanne L, Hurme S, Sippola S, Rautio T, Nordstrom P, Rantanen T, Pinta T, Ilves I, Mattila A, Savela EL, Rintala J, Paajanen H, Gronroos J, Haijanen J, Salminen P. Prognostic factors associated with primary non-responsiveness to antibiotics and appendicitis recurrence for CT-diagnosed uncomplicated acute appendicitis: secondary analysis of two randomized clinical trials. Br J Surg. 2025 Jul 3;112(7):znaf143. doi: 10.1093/bjs/znaf143.
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.
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.
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.
Other Identifiers
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APPAC
Identifier Type: -
Identifier Source: org_study_id
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