LAParoscopic Entry Technique in REnal Surgery
NCT03306238 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2017-12-21
Summary
This is a randomised controlled trial to evaluate safety and efficacy of two different port site entry techniques in laparoscopic renal surgery: open method (Hasson) and closed method (Veress). It will involve 300 adult patients undergoing elective laparoscopic renal surgery in Tallaght hospital under two Consultant urologists.
Conditions
Interventions
- PROCEDURE
-
Open approach to port insertion
This involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope
- PROCEDURE
-
Closed approach to port insertion
This involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity).
Sponsors & Collaborators
-
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
lead OTHER
Principal Investigators
-
Arun Z Thomas · AMNCH, Tallaght hospital, Dublin 24
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-01
- Primary Completion
- 2019-10-01
- Completion
- 2019-12-31
Countries
- Ireland
Study Locations
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