Renal Cell Carcinoma
Conditions
Keywords
Robot; Laparoscopic, Partial nephrectomy, Transperitoneal, Retroperitoneal, Laparoscopic Surgery, Surgical Procedures, Robotic, Nephrectomy
Brief summary
Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter operative time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared with TP approach. Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).
Detailed description
Partial nephrectomy is the standard treatment for small renal masses. The evolution of minimally invasive partial nephrectomy led to widespread utilization of laparoscopic (LPN) and robotic partial nephrectomy (RPN). Both LPN and RPN can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter OT, less EBL, shorter LOS compared with TP approach. Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN). The purpose of this study To compare the treatment outcomes of the transperitoneal and retroperitoneal approach during LPN or RPN in treatment of small renal masses. Inclusion criteria During the study period, a small renal mass (less than 4cm, T1a stage) patients are going to underwent LPN or RPN. Exclusion criteria 1. Patients who underwent radical nephrectomy 2. Patients with bilateral renal masses 3. Patients with a solitary kidney 4. Patients reject a written informed consent 5. Pregnancy The number of target subjects More than 106 patients who meet the inclusion criteria
Interventions
PROCEDURELaparoscopic or robotic partial nephrectomy
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients are going to undergo LPN or RPN with renal mass =\<4cm
Exclusion criteria
* Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | Operative time of partial nephrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Warm ischemic time (minutes) | Intraoperative | Vessel clamping time during partial nephrectomy |
| Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification | from date of surgery, to 1 year postoperatively | — |
| Change of differential glomerular filtration rate (dGFR) measured by renal scan | Preoperative dGFR and postoperative 1 year | — |
| Overall disease-free survival time (month) | from date of surgery, to 1 year postoperatively | Disease free means no local recurrence, no metastasis. |
Countries
South Korea
Contacts
Primary ContactSeongil Seo, MD
Backup ContactInhyuck Gong, Doctor
Outcome results
None listed