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

  • Study Type

  • Intervention/Treatment

    ertapenem ...
  • Study Participants

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.
Study Started
Nov 30
Primary Completion
Jun 30
Study Completion
Dec 31
Results Posted
Feb 23
Last Update
Jun 28

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.

Operative treatment Active Comparator

Regular open appendicectomy

Antibiotic treatment Active Comparator

Ertapenem 1 g i.v. x 1 three days


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



Antibiotic Therapy

All Events

Event Type Organ System Event Term Appendectomy Antibiotic Therapy

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.


percentage of successful treatment
95% Confidence Interval: 98.0 to 100.0

Antibiotic Therapy

percentage of successful treatment
95% Confidence Interval: 66.8 to 78.0

The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment

Outcome Measure Data Not Reported

The Direct and Indirect Costs of Both Treatment Arms

Outcome Measure Data Not Reported

The Recurrence of Conservatively Treated Appendicitis

Outcome Measure Data Not Reported



Age, Categorical

Region of Enrollment

Sex/Gender, Customized

Overall Study


Antibiotic Therapy