An interventional study of Laparoscopic or robotic partial nephrectomy in Renal Cell Carcinoma, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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).
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
The number of target subjects More than 106 patients who meet the inclusion criteria
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's planned enrollment of 106 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach
Procedure: Laparoscopic or robotic partial nephrectomy
Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach
Procedure: Laparoscopic or robotic partial nephrectomy
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach
Operative time
Operative time of partial nephrectomy
Time frame: Intraoperative
Warm ischemic time (minutes)
Vessel clamping time during partial nephrectomy
Time frame: Intraoperative
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification
Time frame: from date of surgery, to 1 year postoperatively
Change of differential glomerular filtration rate (dGFR) measured by renal scan
Time frame: Preoperative dGFR and postoperative 1 year
Overall disease-free survival time (month)
Disease free means no local recurrence, no metastasis.
Time frame: from date of surgery, to 1 year postoperatively
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center