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Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (APPAC)

T

Turku University Hospital (TYKS)

Status

Active, not recruiting

Conditions

Acute Appendicitis

Treatments

Procedure: Appendicectomy
Drug: Ertapenem

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

530 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

530 participants in 2 patient groups

Operative treatment
Active Comparator group
Description:
Regular open appendicectomy
Treatment:
Procedure: Appendicectomy
Antibiotic treatment
Active Comparator group
Description:
Ertapenem 1 g i.v. x 1 three days
Treatment:
Drug: Ertapenem

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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