XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.
NCT ID: NCT00731107
Last Updated: 2008-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2008-09-30
2009-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Veress Needle laparoscopic entry
laparoscopic surgery
Veress Needle laparoscopic entry
2
XCEL bladeless trocar laparoscopic entry
laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
Interventions
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laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
laparoscopic surgery
Veress Needle laparoscopic entry
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Southern Health
OTHER
Responsible Party
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Southern Health
Locations
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Southern Health Department of Obstetrics and Gynaecology
Level 5, Monash Medical Centre, 256 Clayton Road, Clayton, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Thomas R Manley, MBBS
Role: primary
Other Identifiers
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TRM-001
Identifier Type: -
Identifier Source: org_study_id