XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

Laparoscopic Surgery Clinical Trial

Official title:

XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00731107
• Other study ID #: TRM-001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 5, 2008
• Last updated: August 7, 2008
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Southern Health
• Contact: Thomas R Manley, MBBS
• Phone: 61 3 9594 6666
• Email: trmanley[@]hotmail.com
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments

Exclusion Criteria:

• Any women considered not eligible for a Veress Needle laparoscopy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Procedure:
• laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
• laparoscopic surgery
Veress Needle laparoscopic entry

Locations

Country	Name	City	State
Australia	Southern Health Department of Obstetrics and Gynaecology	Level 5, Monash Medical Centre, 256 Clayton Road, Clayton	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Southern Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary out come measure is time to entry in laparoscopic surgery		1 year	No
Secondary	number of attempts at entry in laparoscopic surgery		1 year	No