Trial Outcomes & Findings for Fast Track Appendectomy for Suppurative Appendicitis (NCT NCT02137603)
NCT ID: NCT02137603
Last Updated: 2023-07-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
Fast Track
Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics.
|
Admission
Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fast Track Appendectomy for Suppurative Appendicitis
Baseline characteristics by cohort
| Measure |
Fast Track
n=18 Participants
Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics.
|
Admission
n=18 Participants
Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
11.6 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
11.2 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hoursOutcome measures
| Measure |
Fast Track
n=18 Participants
Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics.
|
Admission
n=18 Participants
Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
|
|---|---|---|
|
Post Operative Length of Stay
|
8.2 Hours
Standard Deviation 18.7
|
23.4 Hours
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Thirty daysSuperficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation
Outcome measures
| Measure |
Fast Track
n=18 Participants
Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics.
|
Admission
n=18 Participants
Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
|
|---|---|---|
|
Thirty Day Complication Rate
|
2 participants
|
1 participants
|
Adverse Events
Fast Track
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Admission
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nicole Chandler
All Children's Hospital Johns Hopkins Medicine
Phone: 727-767-4170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place