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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.
Scientific title
XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.
Secondary ID [1] 0 0
TRM-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary out come measure is time to entry in laparoscopic surgery
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
number of attempts at entry in laparoscopic surgery
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any women considered not eligible for a Veress Needle laparoscopy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2009
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Southern Health Department of Obstetrics and Gynaecology - Level 5, Monash Medical Centre, 256 Clayton Road, Clayton
Recruitment postcode(s) [1] 0 0
3168 - Level 5, Monash Medical Centre, 256 Clayton Road, Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Southern Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00731107
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas R Manley, MBBS
Address 0 0
Country 0 0
Phone 0 0
61 3 9594 6666
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00731107