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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]

TRM-001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Laparoscopic Surgery

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]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Primary out come measure is time to entry in laparoscopic surgery

Timepoint [1]

1 year

Secondary outcome [1]

number of attempts at entry in laparoscopic surgery

Timepoint [1]

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]

Southern Health Department of Obstetrics and Gynaecology - Level 5, Monash Medical Centre, 256 Clayton Road, Clayton

Recruitment postcode(s) [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Thomas R Manley, MBBS

Address

Country

Phone

61 3 9594 6666

Fax

trmanley@hotmail.com

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

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00731107