Clinical trial NCT01022567: Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
Official title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Appendicitis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Oulu University Hospital
name: Tampere University Hospital
name: Mikkeli Central Hospital
name: Jyväskylä Central Hospital
name: Seinajoki Central Hospital
First posted: 2009-12-01
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
timeFrame: Up to 10 years
Secondary outcomes:
measure: The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
timeFrame: 1 year
measure: The Direct and Indirect Costs of Both Treatment Arms
timeFrame: 1 year
measure: The Recurrence of Conservatively Treated Appendicitis
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Keski-Suomi Central Hosptal
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Department of surgery, Turku University Hospital
name: Paulina Salminen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.