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Sponsored by: |
Southern Health |
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Information provided by: | Southern Health |
ClinicalTrials.gov Identifier: | NCT00731107 |
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:
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 |
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Laparoscopic Surgery |
Procedure: laparoscopic surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment |
Official Title: | XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery. |
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 |
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1: Active Comparator
Veress Needle laparoscopic entry
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Procedure: laparoscopic surgery
Veress Needle laparoscopic entry
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2: Active Comparator
XCEL bladeless trocar laparoscopic entry
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Procedure: laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas R Manley, MBBS | 61 3 9594 6666 | trmanley@hotmail.com |
Contact: Jason Tan, MBBS | 61 3 9594 6666 | jasontan@iinet.net.au |
Australia, Victoria | |
Southern Health Department of Obstetrics and Gynaecology | |
Level 5, Monash Medical Centre, 256 Clayton Road, Clayton, Victoria, Australia, 3168 |
Responsible Party: | Southern Health ( Dr Thomas Manley ) |
Study ID Numbers: | TRM-001 |
Study First Received: | August 5, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00731107 |
Health Authority: | Australia: Human Research Ethics Committee |
Veress Needle XCEL bladeless trocar Laparoscopic entry techniques |