Trial Outcomes & Findings for Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (NCT NCT01022567)
NCT ID: NCT01022567
Last Updated: 2018-06-28
Results Overview
A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
530 participants
Primary outcome timeframe
Up to 10 years
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
Appendectomy
Open appendectomy
|
Antibiotic Therapy
Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.
|
|---|---|---|
|
Overall Study
STARTED
|
273
|
257
|
|
Overall Study
COMPLETED
|
272
|
242
|
|
Overall Study
NOT COMPLETED
|
1
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis
Baseline characteristics by cohort
| Measure |
Operative Treatment
n=273 Participants
Regular open appendicectomy
Appendicectomy: Standard appendicectomy
|
Antibiotic Treatment
n=257 Participants
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.
|
Total
n=530 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
273 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
530 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
99 participants
n=5 Participants
|
102 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
174 participants
n=5 Participants
|
155 participants
n=7 Participants
|
329 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
273 participants
n=5 Participants
|
257 participants
n=7 Participants
|
530 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 10 yearsPopulation: Treatment success
A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
Outcome measures
| Measure |
Appendectomy
n=273 Participants
|
Antibiotic Therapy
n=257 Participants
|
|---|---|---|
|
The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
|
99.6 percentage of successful treatment
Interval 98.0 to 100.0
|
72.7 percentage of successful treatment
Interval 66.8 to 78.0
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 yearsOutcome measures
Outcome data not reported
Adverse Events
Appendectomy
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Antibiotic Therapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Appendectomy
n=273 participants at risk
Open appendectomy
|
Antibiotic Therapy
n=257 participants at risk
Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days
|
|---|---|---|
|
Infections and infestations
Overall morbidity
|
16.5%
45/273
|
2.3%
6/257
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place