Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Southern Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Southern Health
ClinicalTrials.gov Identifier:
NCT00731107
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

The method most commonly used to gain entry to the abdomen in laparoscopic surgery (minimally invasive surgery) amongst gynecologists is the Veress Needle. This needle is inserted, usually near the belly button, before adding gas to the abdomen. With a pressurised abdomen a sharp trocar is then inserted to hold the operating telescope.

The XCEL bladeless trocar is another method of inserting the operating telescope whereby you don't need to first introduce gas before the trocar. This trocar is widely used in laparoscopic surgery but it is uncommon to the field of gynecology.

This study will compare the two methods with regard to:

  1. Time taken to enter the abdomen
  2. The number of attempts taken to enter the abdomen
  3. The impact of the time taken to enter compared to the whole operating time
  4. The happiness that the surgeon has entered the abdomen before adding gas, on a scale of 1 to 5.

Patients will be recruited into the trial through the Monash Medical Centre Gynecology department and the Mercy Hospital for Women Gynecology department. Patients that are having laparoscopic surgery and would usually have a Veress Needle entry are suitable for this trial. A patient information sheet will be provided and written consent will then be obtained. Patients who give written consent will be randomised into one of two arms of the trial, either the control (Veress Needle) or the XCEL bladeless trocar arm.

Information will be entered on a proforma by a researcher for each patient during their operation. All patient information will be strictly confidential and only be available to researchers directly involved in the study.

Surgeons operating as part of the project are the consultants and fellow of the gynecology department of Monash Medical Centre and Mercy Hospital for Women and are competent in both techniques.

200 women will be recruited over a one year period and the data will then be analysed with the help of a statistician.


Condition Intervention
Laparoscopic Surgery
Procedure: laparoscopic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

Further study details as provided by Southern Health:

Primary Outcome Measures:
  • Primary out come measure is time to entry in laparoscopic surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of attempts at entry in laparoscopic surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Veress Needle laparoscopic entry
Procedure: laparoscopic surgery
Veress Needle laparoscopic entry
Active Comparator: 2
XCEL bladeless trocar laparoscopic entry
Procedure: laparoscopic surgery
XCEL bladeless trocar laparoscopic entry

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments

Exclusion Criteria:

  • Any women considered not eligible for a Veress Needle laparoscopy
  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: NCT00731107

Contacts
Contact: Thomas R Manley, MBBS 61 3 9594 6666 trmanley@hotmail.com
Contact: Jason Tan, MBBS 61 3 9594 6666 jasontan@iinet.net.au

Locations
Australia, Victoria
Southern Health Department of Obstetrics and Gynaecology Not yet recruiting
Level 5, Monash Medical Centre, 256 Clayton Road, Clayton, Victoria, Australia, 3168
Contact: Thomas R Manley, MBBS    61 3 9594 6666    trmanley@hotmail.com   
Sponsors and Collaborators
Southern Health
  More Information

No publications provided

Responsible Party: Dr Thomas Manley, Southern Health
ClinicalTrials.gov Identifier: NCT00731107     History of Changes
Other Study ID Numbers: TRM-001
Study First Received: August 5, 2008
Last Updated: August 7, 2008
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Southern Health:
Veress Needle
XCEL bladeless trocar
Laparoscopic entry techniques

ClinicalTrials.gov processed this record on November 25, 2014