Intraoperative Trocar Slippage Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01476748
First received: November 18, 2011
Last updated: September 8, 2014
Last verified: September 2014
Results First Received: August 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Trocar Slippage
Intervention: Device: LaproStop

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place in a tertiary hospital, from 12-26-12 to 06-18-13

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants were included in the trial

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Covidien Veraport Trocars     Ethicon Xcel Trocars     Storz Reusable Trocars  
STARTED     5     5     5  
COMPLETED     5     5     5  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Covidien Veraport Trocars     Ethicon Xcel Trocars     Storz Reusable Trocars     Total  
Number of Participants  
[units: participants]
  5     5     5     15  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     5     5     5     15  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 2.48     43  ± 9.61     44.6  ± 6.34     45.13  ± 6.63  
Gender  
[units: participants]
       
Female     5     5     5     15  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     5     5     5     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Trocar Slippages With LaproStop   [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ]

2.  Secondary:   Trocar Slippages Without LaproStop   [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no adverse events encountered during this study


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. JI Einarsson
Organization: BWH
phone: 617-525-8582
e-mail: jeinarsson@partners.org


No publications provided


Responsible Party: Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01476748     History of Changes
Other Study ID Numbers: 2011P001825
Study First Received: November 18, 2011
Results First Received: August 23, 2013
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board