None listed
Conditions
Brief summary
The purpose of this study is to assess whether early unclamping during robot assisted partial nephrectomy surgery for kidney cancer is superior to regular clamping in maintaining renal function 6 months after surgery Who is it for? You may be eligible for this study if you are aged at least 18 years and are undergoing a partial nephrectomy for kidney cancer with one of the participating surgeons involved in this study. Study details Participants in this study will be randomised (by chance) into two groups. Both groups will have urine and blood tests, a CT-scan and a DTPA renal scan before surgery. Both groups will then undergo their planed partial nephrectomy procedure. One group will have their renal blood vessels unclamped at the regular (standard) time during the procedure, and the other group will have their renal blood vessels unclamped slightly earlier during the procedure. All participants will have repeat blood and urine tests at 6 timepoints over the 2 years following their surgery, and a repeat CT-scan and DTPA-scan at 6 months after their surgery. It is intended that this study will help to find out which clamping technique (regular or early unclamping) is better for maintaining kidney function after partial nephrectomy surgery.
Interventions
Participants in the intervention group will first complete a pre-operative medical history form with their treating surgeon, and undergo pre-operative blood and urine tests. They will then be referred to have a CT-scan and a DTPA renal scan at their treating hospital (or chosen radiology provider). Participants will then proceed to a robotic-assisted partial-nephrectomy surgery, incorporating the early unclamping of their renal blood vessels during surgery (unclamping before closure of the renal
Participants in the intervention group will first complete a pre-operative medical history form with their treating surgeon, and undergo pre-operative blood and urine tests. They will then be referred to have a CT-scan and a DTPA renal scan at their treating hospital (or chosen radiology provider). Participants will then proceed to a robotic-assisted partial-nephrectomy surgery, incorporating the early unclamping of their renal blood vessels during surgery (unclamping before closure of the renal capsule, the 'intervention'), completed by their treating surgeon. After surgery, intervention participants will complete a series of 6 post-operative blood and urine tests at set follow-up timepoints up to two years post-operative when visiting their surgeon for post-operative review/management appointments. They will also undergo post-operative CT-scan and DTPA renal scan at 6 months post-operative. The control (comparator) group will undergo all these procedures as well, except their renal blood vessels will not be unclamped early during partial nephrectomy surgery (instead, unclamped after closure of the renal capsule).
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years and over; 2. Legally capable and competent to give written informed consent for participation; 3. Undergoing partial nephrectomy for a cT1 kidney tumor; 4. Elective procedure; 5. Healthy contralateral kidney; 6. RENAL score up to or equal to 8
Exclusion criteria
1. Patients unwilling or unable to undergo all pre- and post-operative evaluations as per protocol; 2. Anatomical or functional solitary kidney; 3. RENAL score > 8; 4. Radiological evidence of locally advanced and/or metastatic disease; 5. Dialysis-dependent chronic kidney disease (CKD stage 4+) 7. Contra-indications for contrast-enhanced computed tomography; 8. Coagulation disorders; 9. Patient or tumor factors precluding robotic surgery
Outcome results
None listed