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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

November 18, 2011
September 8, 2014
December 2012
June 2013   (final data collection date for primary outcome measure)
Trocar Slippages With LaproStop [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ] [ Designated as safety issue: No ]
Number of participants with slippages with LaproStop
Quantify the frequency and extent of trocar slippage during complex laparoscopic gynecologic surgeries [ Time Frame: After the trocars have been positioned into the subject's abdomen but before the procedure starts and between 30 and 45 minutes after the start of the case, baseline measurements of each trocar's insertion depth will be measured ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01476748 on ClinicalTrials.gov Archive Site
Trocar Slippages Without LaproStop [ Time Frame: During the hysterectomy procedure, up to 2 hours and 32 minutes ] [ Designated as safety issue: No ]
Number of participants with slippages with LaproStop
Determine if there are trocar slippage differences between three commonly used types of trocars and to determine if a new device - LaproStop - can effectively eliminate trocar slippage. [ Time Frame: After the trocars have been positioned into the subject's abdomen but before the procedure starts and between 30 and 45 minutes after the start of the case, baseline measurements of each trocar's insertion depth will be measured ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intraoperative Trocar Slippage Study
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Trocar Slippage
Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.
  • Active Comparator: Ethicon Xcel Trocars
    Ethicon Xcel trocars will be used in this arm with Laprostop device
    Intervention: Device: LaproStop
  • Active Comparator: Covidien Veraport Trocars
    Covidien Veraport Trocars will be used in this arm with the Laprostop device
    Intervention: Device: LaproStop
  • Active Comparator: Storz Reusable Trocars
    Storz Reusable Trocars will be used in this arm with the Laprostop device
    Intervention: Device: LaproStop
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01476748
2011P001825
No
Jon I. Einarsson, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Jon I Einarsson, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP