Trial Outcomes & Findings for A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy (NCT NCT00895284)
NCT ID: NCT00895284
Last Updated: 2013-06-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
At skin closure.
Results posted on
2013-06-28
Participant Flow
All subjects were recruited at Mayo Clinic in Arizona.
Participant milestones
| Measure |
Robot
Robotic hysterectomy
|
Standard
Standard hysterectomy
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy
Baseline characteristics by cohort
| Measure |
Robot
n=3 Participants
Robotic hysterectomy
|
Standard
Standard hysterectomy
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age Categorical
Between 18 and 65 years
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Female
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At skin closure.Population: The study was terminated due to lack of funding; due to the small sample size, no analysis was done.
Outcome measures
Outcome data not reported
Adverse Events
Robot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard
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