Intraoperative Trocar Slippage Study
Phase 3
Completed
- Conditions
- Trocar Slippage
- Interventions
- Device: LaproStop
- Registration Number
- NCT01476748
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Covidien Veraport Trocars LaproStop Covidien Veraport Trocars will be used in this arm with the Laprostop device Storz Reusable Trocars LaproStop Storz Reusable Trocars will be used in this arm with the Laprostop device Ethicon Xcel Trocars LaproStop Ethicon Xcel trocars will be used in this arm with Laprostop device
- Primary Outcome Measures
Name Time Method Trocar Slippages With LaproStop During the hysterectomy procedure, up to 2 hours and 32 minutes Number of participants with slippages with LaproStop
- Secondary Outcome Measures
Name Time Method Trocar Slippages Without LaproStop During the hysterectomy procedure, up to 2 hours and 32 minutes Number of participants with slippages with LaproStop
Trial Locations
- Locations (1)
Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States