Intraoperative Trocar Slippage Study
September 8, 2014 updated by: Jon I. Einarsson, Brigham and Women's Hospital
A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ethicon Xcel Trocars
Ethicon Xcel trocars will be used in this arm with Laprostop device
|
One of the subject's trocars will be randomized to be used with a LaproStop device.
|
|
Active Comparator: Covidien Veraport Trocars
Covidien Veraport Trocars will be used in this arm with the Laprostop device
|
One of the subject's trocars will be randomized to be used with a LaproStop device.
|
|
Active Comparator: Storz Reusable Trocars
Storz Reusable Trocars will be used in this arm with the Laprostop device
|
One of the subject's trocars will be randomized to be used with a LaproStop device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trocar Slippages With LaproStop
Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes
|
Number of participants with slippages with LaproStop
|
During the hysterectomy procedure, up to 2 hours and 32 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trocar Slippages Without LaproStop
Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes
|
Number of participants with slippages with LaproStop
|
During the hysterectomy procedure, up to 2 hours and 32 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jon I Einarsson, MD, MPH, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
November 18, 2011
First Submitted That Met QC Criteria
November 21, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Estimate)
September 17, 2014
Last Update Submitted That Met QC Criteria
September 8, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 2011P001825
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.