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Status unknownNCT00731107Updated Aug 8, 2008

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

An interventional study of laparoscopic surgery and laparoscopic surgery in Laparoscopic Surgery, sponsored by Southern Health. Status unknown at 1 site in Australia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-08.

Sponsored by Southern Health · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Laparoscopic Surgery

Keywords

  • Veress Needle
  • XCEL bladeless trocar
  • Laparoscopic entry techniques
03

In context

Lead sponsor

Southern Health is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any women considered not eligible for a Veress Needle laparoscopy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    1

    Veress Needle laparoscopic entry

    Procedure: laparoscopic surgery

  • Active comparator
    2

    XCEL bladeless trocar laparoscopic entry

    Procedure: laparoscopic surgery

Interventions

  • Procedurelaparoscopic surgery

    XCEL bladeless trocar laparoscopic entry

  • Procedurelaparoscopic surgery

    Veress Needle laparoscopic entry

06

What researchers measure

Primary outcomes

  1. Primary out come measure is time to entry in laparoscopic surgery

    Time frame: 1 year

Secondary outcomes

  1. number of attempts at entry in laparoscopic surgery

    Time frame: 1 year

07

Study locations

1 site
  • Southern Health Department of Obstetrics and Gynaecology
    Level 5, Monash Medical Centre, 256 Clayton Road, Clayton, Victoria 3168, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00731107
Lead sponsor
Southern Health
First posted
Aug 8, 2008
Start date
Sep 2008
Primary completion
Sep 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Aug 8, 2008

Study contacts

Thomas R Manley, MBBS
Contact
trmanley@hotmail.com
61 3 9594 6666
Jason Tan, MBBS
Contact
jasontan@iinet.net.au
61 3 9594 6666

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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