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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Mikkeli Central Hospital | OTHER |
| Jyväskylä Central Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative treatment | Active Comparator | Regular open appendicectomy |
|
| Antibiotic treatment | Active Comparator | Ertapenem 1 g i.v. x 1 three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Appendicectomy | Procedure | Standard appendicectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment | 1 year | |
| The Direct and Indirect Costs of Both Treatment Arms | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulina Salminen, MD, PhD | Department of surgery, Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keski-Suomi Central Hosptal | Jyväskylä | Finland | ||||
| Mikkeli Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23394263 | Background | 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. | |
| 26080338 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Appendectomy | Open appendectomy |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Operative Treatment | Regular open appendicectomy Appendicectomy: Standard appendicectomy |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Treatment success | Posted | Number | 95% Confidence Interval | percentage of successful treatment | Up to 10 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Appendectomy | Open appendectomy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overall morbidity | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paulina Salminen | Turku University Hospital | +358 2 313 0542 | paulina.salminen@tyks.fi |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D001062 | Appendectomy |
| D000077727 | Ertapenem |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
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| OTHER |
| Seinajoki Central Hospital | OTHER |
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| Ertapenem |
| Drug |
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. |
|
| The Recurrence of Conservatively Treated Appendicitis |
| up to 10 years |
| Mikkeli |
| Finland |
| Oulu University Hospital | Oulu | Finland |
| Seinäjoki Central Hospital | Seinäjoki | Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| 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. |
| 41563747 | Derived | Salminen P, Salminen R, Kallio J, Hurme S, Nordstrom P, Rantanen T, Paajanen H, Aarnio M, Mecklin JP, Sand J, Gronroos JM, Rautio T. Antibiotic Therapy for Uncomplicated Acute Appendicitis: Ten-Year Follow-Up of the APPAC Randomized Clinical Trial. JAMA. 2026 Mar 24;335(12):1041-1049. doi: 10.1001/jama.2025.25921. |
| 40741675 | Derived | 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. |
| 32074268 | Derived | 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. |
| 30264120 | Derived | 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. |
| 28591824 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment | Not Posted | 1 year | Participants |
| Secondary | The Direct and Indirect Costs of Both Treatment Arms | Not Posted | 1 year | Participants |
| Secondary | The Recurrence of Conservatively Treated Appendicitis | Not Posted | Jun 2022 | up to 10 years | Participants |
| 0 |
| 273 |
| 45 |
| 273 |
| EG001 | 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 | 0 | 257 | 6 | 257 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |