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

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Procedure: laparoscopic surgery; Procedure: laparoscopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas R Manley, MBBS; Phone Number: 61 3 9594 6666; Email: trmanley@hotmail.com
• Study Contact Backup: Name: Jason Tan, MBBS; Phone Number: 61 3 9594 6666; Email: jasontan@iinet.net.au

Study Locations

• Australia
  • Victoria
    • Level 5, Monash Medical Centre, 256 Clayton Road, Clayton, Victoria, Australia, 3168
      • Southern Health Department of Obstetrics and Gynaecology
      • Contact: Thomas R Manley, MBBS; Phone Number: 61 3 9594 6666; Email: trmanley@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Veress Needle laparoscopic entry	Procedure: laparoscopic surgery; XCEL bladeless trocar laparoscopic entry; Procedure: laparoscopic surgery; Veress Needle laparoscopic entry
ACTIVE_COMPARATOR: 2; XCEL bladeless trocar laparoscopic entry	Procedure: laparoscopic surgery; XCEL bladeless trocar laparoscopic entry; Procedure: laparoscopic surgery; Veress Needle laparoscopic entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary out come measure is time to entry in laparoscopic surgery	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
number of attempts at entry in laparoscopic surgery	1 year

Collaborators and Investigators

• Sponsor: Southern Health

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ANTICIPATED): September 1, 2009
• Study Completion (ANTICIPATED): December 1, 2009

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (ESTIMATE): August 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2008
• Last Update Submitted That Met QC Criteria: August 7, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Veress Needle; XCEL bladeless trocar; Laparoscopic entry techniques
• Other Study ID Numbers: TRM-001