MedPath

VDT TRIA

Not Applicable
Recruiting
Conditions
Surgery
Fertility-female
Laparoscopy 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
NameTimeMethod
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
NameTimeMethod
extraperitoneal insufflation and trocar site bleeding.
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