Trial Outcomes & Findings for Intraoperative Pathway in DIEP Flap Breast Reconstruction (NCT NCT00543764)
NCT ID: NCT00543764
Last Updated: 2019-03-07
Results Overview
Length of Time in surgery
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
3 years
Results posted on
2019-03-07
Participant Flow
2006-2008. Operating room records
Participant milestones
| Measure |
Pre Pathway
Patients prior to pathway implementation
|
Post Pathway
Patients after pathway implementation
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
50
|
|
Overall Study
COMPLETED
|
100
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Pathway in DIEP Flap Breast Reconstruction
Baseline characteristics by cohort
| Measure |
Pre Pathway
n=100 Participants
Patients prior to pathway implementation
|
Post Pathway
n=50 Participants
Patients after pathway implementation
|
Total
n=150 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
|
100 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
150 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
|
100 paticipants
n=5 Participants
|
50 paticipants
n=7 Participants
|
150 paticipants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
0 paticipants
n=5 Participants
|
0 paticipants
n=7 Participants
|
0 paticipants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsLength of Time in surgery
Outcome measures
| Measure |
Pre Pathway
n=100 Participants
Patients prior to pathway implementation
|
Post Pathway
n=50 Participants
Patients after pathway implementation
|
|---|---|---|
|
Operative Time
|
8.2 hours
Interval 7.8 to 8.6
|
6.9 hours
Interval 6.3 to 7.5
|
Adverse Events
Pre Pathway
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post Pathway
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place