Powered Vascular Stapler Study in Renal Surgery
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
IRAS ID
198595
Contact name
Erin Creedon
Contact email
Sponsor organisation
Ethicon Endo-Surgery, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
The objective of this study is to demonstrate that the frequency of bleeding related interventions/procedures required intra-operatively or post-operatively related to the cutting and stapling of the renal artery (RA) and renal vein (RV) during simple, radical laparoscopic nephrectomies (kidney removal) or laparoscopic nephroureterectomies (removal of kidney and ureter) with Powered Vascular Stapler is not increased when compared to the standard of care (SOC) stapler.\n\nPatients will be reviewed approximately 1-2 weeks before their procedure, on the day of the procedure, at discharge and finally 4 weeks after their procedure. This final visit can be done by telephone call or office visit. \n\nPost-operatively the focus of the study is safety information collection in the form of adverse events and any medications used to treat them and information on any renal artery or vein related interventions.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0125
Date of REC Opinion
20 Apr 2016
REC opinion
Further Information Favourable Opinion