Comparison of Surgical Outcomes Between MPCNL and RIRS

NCT ID: NCT02067221

Last Updated: 2015-06-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-02-28

Brief Summary

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The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.

Detailed Description

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It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.

Conditions

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Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIRS (retrograde intrarenal surgery)

Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract

Group Type ACTIVE_COMPARATOR

RIRS

Intervention Type DEVICE

* RIRS arm
* Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract

MPCNL (mini-perc)

A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.

Patients will be randomized and assigned to each group at the ratio 1:1

Group Type EXPERIMENTAL

MPCNL

Intervention Type DEVICE

* MPCNL arm
* A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.

Interventions

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RIRS

* RIRS arm
* Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract

Intervention Type DEVICE

MPCNL

* MPCNL arm
* A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.

Intervention Type DEVICE

Other Intervention Names

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retrograde intrerenal surgery minimally invasive percuntaneous nephrolithotomy mini-perc

Eligibility Criteria

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Inclusion Criteria

* The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS.
* The person who signed up for participation and agree with intention of clinical test.

Exclusion Criteria

* The patient whose medical record has been omitted from database.
* The patient who has an anatomical abnormality of urinary tract and/or metabolic illness
* The patient who do not agree with the intention of the clinical study.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Telecom Consortium

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyeon Jeong

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung Yong Cho, Ph.D

Role: STUDY_DIRECTOR

SMG-SNU Boramae Medical Center

Locations

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SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MPCNL Study

Identifier Type: -

Identifier Source: org_study_id

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