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
  Purpose

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 Intervention Phase
Trocar Slippage
Device: LaproStop
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jon I. Einarsson, MD, MPH, 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

ClinicalTrials.gov processed this record on October 23, 2014