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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00731107
Registration number
NCT00731107
Ethics application status
Date submitted
5/08/2008
Date registered
8/08/2008
Date last updated
8/08/2008
Titles & IDs
Public title
XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.
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Scientific title
XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.
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Secondary ID [1]
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TRM-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Surgery
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - laparoscopic surgery
Treatment: Surgery - laparoscopic surgery
Active comparator: 1 - Veress Needle laparoscopic entry
Active comparator: 2 - XCEL bladeless trocar laparoscopic entry
Treatment: Surgery: laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
Treatment: Surgery: laparoscopic surgery
Veress Needle laparoscopic entry
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary out come measure is time to entry in laparoscopic surgery
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Assessment method [1]
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Timepoint [1]
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1 year
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Secondary outcome [1]
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number of attempts at entry in laparoscopic surgery
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Assessment method [1]
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Timepoint [1]
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1 year
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Eligibility
Key inclusion criteria
* Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Any women considered not eligible for a Veress Needle laparoscopy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2009
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Southern Health Department of Obstetrics and Gynaecology - Level 5, Monash Medical Centre, 256 Clayton Road, Clayton
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Recruitment postcode(s) [1]
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3168 - Level 5, Monash Medical Centre, 256 Clayton Road, Clayton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Southern Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00731107
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Thomas R Manley, MBBS
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Address
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Country
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Phone
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61 3 9594 6666
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00731107
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