Trocar Slippage
Conditions
Brief summary
The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage. Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.
Interventions
DEVICELaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trocar Slippages With LaproStop | During the hysterectomy procedure, up to 2 hours and 32 minutes | Number of participants with slippages with LaproStop |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trocar Slippages Without LaproStop | During the hysterectomy procedure, up to 2 hours and 32 minutes | Number of participants with slippages with LaproStop |
Countries
United States
Participant flow
Recruitment details
Recruitment took place in a tertiary hospital, from 12-26-12 to 06-18-13
Pre-assignment details
All enrolled participants were included in the trial
Participants by arm
| Arm | Count |
|---|---|
| Covidien Veraport Trocars LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. | 5 |
| Ethicon Xcel Trocars LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. | 5 |
| Storz Reusable Trocars LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | Ethicon Xcel Trocars | Storz Reusable Trocars | Covidien Veraport Trocars | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 9.61 | 44.6 years STANDARD_DEVIATION 6.34 | 47.8 years STANDARD_DEVIATION 2.48 | 45.13 years STANDARD_DEVIATION 6.63 |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Trocar Slippages With LaproStop
Number of participants with slippages with LaproStop
Time frame: During the hysterectomy procedure, up to 2 hours and 32 minutes
Population: Pilot study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Covidien Versaport Trocars | Trocar Slippages With LaproStop | 1 Participants |
| Ethicon Xcel Trocars | Trocar Slippages With LaproStop | 2 Participants |
| Storz Reusable Trocars | Trocar Slippages With LaproStop | 3 Participants |
Secondary
Trocar Slippages Without LaproStop
Number of participants with slippages with LaproStop
Time frame: During the hysterectomy procedure, up to 2 hours and 32 minutes
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Covidien Versaport Trocars | Trocar Slippages Without LaproStop | 0 Participants | 4.47 |
| Ethicon Xcel Trocars | Trocar Slippages Without LaproStop | 2 Participants | 2.68 |
| Storz Reusable Trocars | Trocar Slippages Without LaproStop | 4 Participants | 2.4 |