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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01022567
Other study ID # APPAC
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date December 2025

Study information

Verified date May 2018
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 530
Est. completion date December 2025
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Appendicectomy
Standard appendicectomy
Drug:
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.

Locations

Country Name City State
Finland 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

Sponsors (6)

Lead Sponsor Collaborator
Turku University Hospital Jyväskylä Central Hospital, Mikkeli Central Hospital, Oulu University Hospital, Seinajoki Central Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Paajanen H, Grönroos JM, Rautio T, Nordström 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. — View Citation

Salminen P, Paajanen H, Rautio T, Nordström P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Grönroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPA — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Up to 10 years
Secondary The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment 1 year
Secondary The Direct and Indirect Costs of Both Treatment Arms 1 year
Secondary The Recurrence of Conservatively Treated Appendicitis up to 10 years
See also
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Terminated NCT04207645 - Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis
Completed NCT04615728 - MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
Not yet recruiting NCT02789865 - Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis Phase 2
Completed NCT02731924 - Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
Completed NCT05104346 - Presentation and Outcomes of Acute Appendicitis During COVID Pandemic N/A
Completed NCT03886896 - Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy Phase 4
Not yet recruiting NCT01720082 - Laparoscopic Appendectomy by Multi-port vs Single Port. Phase 3
Completed NCT01348464 - A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy N/A

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