Trial Outcomes & Findings for Intraoperative Trocar Slippage Study (NCT NCT01476748)
NCT ID: NCT01476748
Last Updated: 2014-09-17
Results Overview
Number of participants with slippages with LaproStop
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
During the hysterectomy procedure, up to 2 hours and 32 minutes
Results posted on
2014-09-17
Participant Flow
Recruitment took place in a tertiary hospital, from 12-26-12 to 06-18-13
All enrolled participants were included in the trial
Participant milestones
| Measure |
Covidien Veraport Trocars
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Ethicon Xcel Trocars
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Storz Reusable Trocars
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Trocar Slippage Study
Baseline characteristics by cohort
| Measure |
Covidien Veraport Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Ethicon Xcel Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Storz Reusable Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 2.48 • n=39 Participants
|
43 years
STANDARD_DEVIATION 9.61 • n=41 Participants
|
44.6 years
STANDARD_DEVIATION 6.34 • n=35 Participants
|
45.13 years
STANDARD_DEVIATION 6.63 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=39 Participants
|
5 participants
n=41 Participants
|
5 participants
n=35 Participants
|
15 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: During the hysterectomy procedure, up to 2 hours and 32 minutesPopulation: Pilot study
Number of participants with slippages with LaproStop
Outcome measures
| Measure |
Covidien Versaport Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Ethicon Xcel Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Storz Reusable Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
|---|---|---|---|
|
Trocar Slippages With LaproStop
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the hysterectomy procedure, up to 2 hours and 32 minutesNumber of participants with slippages with LaproStop
Outcome measures
| Measure |
Covidien Versaport Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Ethicon Xcel Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
Storz Reusable Trocars
n=5 Participants
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
|---|---|---|---|
|
Trocar Slippages Without LaproStop
|
0 Participants
4.47
|
2 Participants
2.68
|
4 Participants
2.4
|
Adverse Events
Covidien Veraport Trocars
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ethicon Xcel Trocars
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Storz Reusable Trocars
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