Acute Appendicitis
Conditions
Brief 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.
Interventions
PROCEDUREAppendicectomy
Standard appendicectomy
DRUGErtapenem
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.
Sponsors
Oulu University Hospital
Tampere University Hospital
Mikkeli Central Hospital
Jyväskylä Central Hospital
Seinajoki Central Hospital
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis | Up to 10 years | A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment. |
Secondary
| Measure | 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 |
| The Recurrence of Conservatively Treated Appendicitis | up to 10 years |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operative Treatment Regular open appendicectomy
Appendicectomy: Standard appendicectomy | 273 |
| 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. | 257 |
| Total | 530 |
Baseline characteristics
| Characteristic | Operative Treatment | Antibiotic Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 273 Participants | 257 Participants | 530 Participants |
| Region of Enrollment Finland | 273 participants | 257 participants | 530 participants |
| Sex/Gender, Customized Female | 99 participants | 102 participants | 201 participants |
| Sex/Gender, Customized Male | 174 participants | 155 participants | 329 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 273 | 6 / 257 |
| serious Total, serious adverse events | 0 / 273 | 0 / 257 |
Outcome results
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.
Time frame: Up to 10 years
Population: Treatment success
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Appendectomy | The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis | 99.6 percentage of successful treatment |
| Antibiotic Therapy | The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis | 72.7 percentage of successful treatment |
Secondary
The Direct and Indirect Costs of Both Treatment Arms
Time frame: 1 year
Secondary
The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment
Time frame: 1 year
Secondary
The Recurrence of Conservatively Treated Appendicitis
Time frame: up to 10 years