Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (<4 cm) amenable to resection using either RALPN or LPN.
Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Assisted Partial Nephrectomy | Active Comparator | Current standard for partial nephrectomies. |
|
| Robotic Assisted Partial Nephrectomy | Active Comparator | Possible new standard for partial nephrectomies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted Nephrectomy | Procedure | Robotic (Davinci) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Warm ischemia time | It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes). | Duration of the Surgical Procedure (Nephrectomy) |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | It will be measured preoperatively, postoperatively and at each of the follow-up visit. | Up to 24 months post operatively. |
| Estimated blood loss | Will be measured intraoperatively from the amount of blood (ml) in the suction container. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anil Kapoor, MD, FRCSC | Contact | 905-522-1155 | 33218 | akapoor@mcmaster.ca |
| Camilla Tajzler, BA, CCRA | Contact | 905-522-1155 | 35876 | tajzlec@mcmaster.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton - McMaster Institute of Urology | Hamilton | Ontario | L8N4A6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
| Laparoscopic Assisted Nephrectomy |
| Procedure |
Regular Laparoscopic Technique. |
|
| Duration of the Surgical Procedure (Nephrectomy) |
| Complication rates as per Clavien-Dindo classification | It will be recorded for the intra-operative, post-operative and follow-up period. | Up to 24 months post-operatively. |
| Conversion rate to radical nephrectomy or OPN due to technical difficulty. | From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy. | Duration of the Surgical Procedure |
| Postoperative pain | Minutes to hours after nephrectomy up to 3 months post-operatively. |
| Length of hospital stay | Calculated from day of admission to day of discharge from hospital. | 3-7 Days |
| Positive surgical margin rate | Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery. Distance to surgical margin will be looked at (mm to cm). | 14 days |
| Costs of treatment | Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St. Joseph Healthcare case-costing system. The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care. The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication. | Up to 1 year |