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Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

Samsung Medical Center logo

Samsung Medical Center

Status

Unknown

Conditions

Renal Cell Carcinoma

Treatments

Procedure: Laparoscopic or robotic partial nephrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02849119
2015-03-068-002

Details and patient eligibility

About

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).

Full 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

Enrollment

106 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

106 participants in 2 patient groups

Transperitoneal approach
Experimental group
Description:
Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach
Treatment:
Procedure: Laparoscopic or robotic partial nephrectomy
Retroperitoneal approach
Experimental group
Description:
Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach
Treatment:
Procedure: Laparoscopic or robotic partial nephrectomy

Trial contacts and locations

1

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Central trial contact

Inhyuck Gong, Doctor; Seongil Seo, MD

Data sourced from clinicaltrials.gov

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