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Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy

NCT ID: NCT02849119

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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

Conditions

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Renal Cell Carcinoma

Keywords

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Robot; Laparoscopic Partial nephrectomy Transperitoneal Retroperitoneal Laparoscopic Surgery Surgical Procedures, Robotic Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Transperitoneal approach

Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach

Group Type EXPERIMENTAL

Laparoscopic or robotic partial nephrectomy

Intervention Type PROCEDURE

Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

Retroperitoneal approach

Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach

Group Type EXPERIMENTAL

Laparoscopic or robotic partial nephrectomy

Intervention Type PROCEDURE

Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

Interventions

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Laparoscopic or robotic partial nephrectomy

Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seongil Seo, MD

Role: STUDY_CHAIR

Urology department of Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seongil Seo, MD

Role: CONTACT

Phone: 82-10-9933-3556

Email: [email protected]

Inhyuck Gong, Doctor

Role: CONTACT

Phone: 82-10-3110-2791

Email: [email protected]

Facility Contacts

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Seongil Seo, MD

Role: primary

Inhyuck Gong, doctor

Role: backup

Other Identifiers

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2015-03-068-002

Identifier Type: -

Identifier Source: org_study_id