Clinical trial NCT02849119: Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy
Official title: Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: Robot; Laparoscopic
Partial nephrectomy
Transperitoneal
Retroperitoneal
Laparoscopic Surgery
Surgical Procedures, Robotic
Nephrectomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: Intraoperative
Secondary outcomes:
measure: Warm ischemic time (minutes)
timeFrame: Intraoperative
measure: Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification
timeFrame: from date of surgery, to 1 year postoperatively
measure: Change of differential glomerular filtration rate (dGFR) measured by renal scan
timeFrame: Preoperative dGFR and postoperative 1 year
measure: Overall disease-free survival time (month)
timeFrame: from date of surgery, to 1 year postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Urology department of Samsung Medical Center
name: Seongil Seo, MD
role: STUDY_CHAIR
References: