Previous and Current Clinical Trials / Protocols

1.Paediatric Urinary calculi Protocol – For the Newcastle upon Tyne hospital NHS trust

Vasdev N 1,2, Willetts I 2, Thomas D 1
1. Department of Urology, Freeman Hospital, Newcastle upon Tyne
2. Department of Paediatric Urology, Royal Victoria Infirmary, Newcastle upon Tyne
I developed a local guideline for the management of Paediatric Urinary Calculi for the Newcastle upon Tyne NHS trust in 08/2009

2. The use of malignant and benign kidneys for renal transplant

Khurram MA 1 , Vasdev N 1,2, Thomas D 2, Soomro D 1,2 , Talbot D 1, Rix D 1,2
1. Department of Renal Transplant, Freeman Hospital Newcastle Upon Tyne, UK
2. Department of Urology, Freeman Hospital Newcastle Upon Tyne, UK
Recent proposal developed for local ethics committee approval of the use of benign and malignant kidneys in for high risk recipients that are not all candidates for the transplant waiting list.

3. Application to permit the use of the Prostate Core Mitomic Test™ (PCMT) to Determine the Performance Parameters of PCMT with Patients with an Initial Negative Prostate Biopsy

Vasdev N 1, Tal Y 1, Nagarajan S 2, Chadwick D 1
1. Department of Urology, James Cook University Hospital, Middlesbrough
2. Department of Histopathology, James Cook University Hospital, Middlesbrough

I am currently completing a national ethic approval for the use of PCMT in patients with initial negative biopsies to assess and improve the sensitivity and positive predictive value of biopsies alone in prostate cancer. One of the persistent challenges of managing the male urological patient, who undergoes prostate biopsy, is oftentimes the result of this procedure itself. The standard practice of removing 12 needle cores is fraught with sampling error because the small diameter of the individual needles samples only 1/2000th of the prostate. If a patient has clinical indications of prostate cancer, such as rising PSA, then a negative biopsy result generally indicates that the suite of biopsy needles missed the tumour. This limitation results in a considerable number of patients with false negative results. A significant subset of these patients will undergo a repeat biopsy procedure. As many as 70% of initial biopsy procedures can be negative and upwards of 40% of these patients are found to have prostate cancer on repeat biopsy. A single mitochondrial deletion assay for field effects in prostatic tissue has significant potential as a clinical tool for management of the patient with a benign prostate biopsy. With a NPV of 92%, patients without prostate cancer may be readily identified, while those who may have occult disease are highlighted as well (Sensitivity 85%).

4. A prospective study to evaluate non-invasive urodynamic parameters both pre and post operatively in patients undergoing a robotic assisted laparoscopic prostatectomy

Vasdev N, Lane T, Boustead G, Adshead J
Hertfordshire and South Bedfordshire Urological Robotic Centre, Lister Hospital, Stevenage
I have received regional ethic approval and £10,000 funding for the study from a regional grant. The study has commenced recruitment in June 2013 and we currently have 3 patients on the study. I am also pursuing this as a component of my ChM (Urol).

5. Enhanced Robotic Cystectomy protocol

Vasdev N, Lane T, Boustead G, Adshead J
Hertfordshire and South Bedfordshire Urological Robotic Centre, Lister Hospital, Stevenage
I have written the Enhanced Robotic Cystectomy protocol for the Lister hospital including a patient diary. The first patient of this protocol has been recruited onto the protocol on 21st June 2013. Using the team approach we have recruited 5 patients and have seen the median inpatient stay drop by 7 days.

6. Intraoperative frozen section of the prostate to reduce the risk of positive margin whilst ensuring nerve sparing in patients with Intermediate and high risk prostate cancer during robotic radical prostatectomy

Vasdev N, Agarwal S, Lane T, Boustead G, Adshead J

The first UK study on the use of intra-operative frozen section of the prostate to reduce the risk of positive surgical margin in patients with intermediate and high-risk prostate cancer. We have now recruited 20 patients into this study from November 2012 until April 2014. I have completed my thesis for my ChM (Urol) degree from the RCSED/ University of Edinburgh on this top and have submitted my thesis on 02/06/2014

7. A prospective study to compare serum cytokine levels in patients undergoing minimally invasive robotic surgery using standard versus AirSeal™ insufflation system

Vasdev N, Gowrie MS, Lane T, Boustead G, Adshead J
Hertfordshire and South Bedfordshire Urological Robotic Centre, Lister Hospital, Stevenage
In our study we will randomize patients into those who have a pneumoperitoneum created either using a standard insufflation system versus an AirSeal™ system. We will then evaluate serum cytokine Levels at day 1 and day 2 following surgery (Interleukin – 1,2,4,7,12 and Tumour Necrosis factor alpha) to Evaluate the effect of intraoperative gut ischemia. Patients with less intra-operative gut ischemia have a lower risk of post-operative ileus and hence a risk of lower post-operative complications. These patients have a higher chance of earlier discharge.

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