VDT TRIA
Not Applicable
Recruiting
- Conditions
- SurgeryFertility-femaleLaparoscopy entry techniques
- Registration Number
- PACTR201510000999192
- Lead Sponsor
- DR GEORGE ELEJE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
Women undergoing diagnostic operative or mixed laparoscopy performed by trained laparoscopic gynaecologists.
Exclusion Criteria
Women with major abdominal distension
WOMEN suspicious of malignancy or malignancy at the histopathological examination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time of umbilical incision;time at telescope withdrawal (B); (3) amount of gas in liters (volume of CO2 required); (4) number of attempts required to achieve successful insertion; (5) overall operative time (from time A to time B; stopwatch started at time A and stopped at time B = overall duration of the procedure in minutes), and (6) occurrence of any complications.;mortality, vascular injury (major vessels and abdominal wall vessels), visceral (bladder or bowel) injury, gas embolism, solid organ injury, failed entry and conversion to the alternate DTI or open technique following failure and evidence of adhesion within the peritoneal cavity.
- Secondary Outcome Measures
Name Time Method extraperitoneal insufflation and trocar site bleeding.