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: January 23, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to find out how much a trocar might slide during a typical laprascopic 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ethicon Xcel Trocars Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.
Active Comparator: Covidien Veraport Trocars Device: LaproStop
One of the subject's trocars will be randomized to be used with a LaproStop device.
Active Comparator: Storz Reusable Trocars 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.

Exclusion Criteria:

  Contacts and Locations
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
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014