Title
Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Phase
N/ALead Sponsor
University of TurkuStudy Type
InterventionalStatus
Active, not recruiting Results PostedIndication/Condition
Acute AppendicitisIntervention/Treatment
ertapenem ...Study Participants
530Appendicectomy 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.
Standard appendicectomy
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.
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
Event Type | Organ System | Event Term | Appendectomy | Antibiotic Therapy |
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A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported