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 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:
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.
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.
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.
Exclusion Criteria:
Veress Needle laparoscopic entry
Procedure: laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
Procedure: laparoscopic surgery
XCEL bladeless trocar laparoscopic entry
Veress Needle laparoscopic entry
Primary out come measure is time to entry in laparoscopic surgery
Time frame: 1 year
number of attempts at entry in laparoscopic surgery
Time frame: 1 year
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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