XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 8, 2008
August 1, 2008
1 year
August 5, 2008
August 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary out come measure is time to entry in laparoscopic surgery
1 year
Secondary Outcomes (1)
number of attempts at entry in laparoscopic surgery
1 year
Study Arms (2)
1
ACTIVE COMPARATORVeress Needle laparoscopic entry
2
ACTIVE COMPARATORXCEL bladeless trocar laparoscopic entry
Interventions
Eligibility Criteria
You may qualify if:
- Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments
You may not qualify if:
- Any women considered not eligible for a Veress Needle laparoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Southern Healthlead
Study Sites (1)
Southern Health Department of Obstetrics and Gynaecology
Level 5, Monash Medical Centre, 256 Clayton Road, Clayton, Victoria, 3168, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
August 8, 2008
Record last verified: 2008-08