We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Trocar Slippage Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01476748
Recruitment Status : Completed
First Posted : November 22, 2011
Results First Posted : August 29, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Jon I. Einarsson, 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.


Condition or disease Intervention/treatment Phase
Trocar Slippage Device: LaproStop Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.
Study Start Date : December 2012
Primary Completion Date : June 2013
Study Completion Date : September 2013

Arm Intervention/treatment
Active Comparator: Ethicon Xcel Trocars
Ethicon Xcel trocars will be used in this arm with Laprostop device
Device: LaproStop
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
Device: LaproStop
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
Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.



Primary Outcome Measures :
  1. Trocar Slippages With LaproStop [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ]
    Number of participants with slippages with LaproStop


Secondary Outcome Measures :
  1. Trocar Slippages Without LaproStop [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ]
    Number of participants with slippages with LaproStop



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476748


Locations
United States, Massachusetts
Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jon I Einarsson, MD, MPH Brigham and Women's Hospital

Responsible Party: Jon I. Einarsson, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01476748     History of Changes
Other Study ID Numbers: 2011P001825
First Posted: November 22, 2011    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: September 17, 2014
Last Verified: September 2014