Comparison of Surgical Outcomes Between MPCNL and RIRS

June 21, 2015 updated by: Hyeon Jeong, Seoul National University Hospital

Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RIRS (retrograde intrarenal surgery)
Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
Device: RIRS
  • RIRS arm
  • Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
Other Names:
  • retrograde intrerenal surgery
Experimental: 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
Device: MPCNL
  • MPCNL arm
  • A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.
Other Names:
  • minimally invasive percuntaneous nephrolithotomy
  • mini-perc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone-free rate
Time Frame: postoperative 1 month
We will check the non-contrast CT scan at postoperative 1month when the patient visit the outpatient department. If the patient does not have any residual stone fragment, it will be reported to 'success.' Otherwise, we will measure the size of each stone of residual fragments.
postoperative 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: postoperative 1 day
Visual analogue scale will be measured: 0 (no pain) -> 10 (the most worst pain ever experienced)
postoperative 1 day
hemoglobin drop
Time Frame: postoperative 1 day
preoperative Hb level - Hb level of immediate postoperative 1 day
postoperative 1 day
occurrence of complications
Time Frame: postoperative 1 day, and the postop 1month at OPD
occurrence of stricture in non-contrast CT scan history taking of hematuria or fever
postoperative 1 day, and the postop 1month at OPD
hospital stay
Time Frame: postoperative 1 month
calculation of days of hospital stay
postoperative 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SK Telecom Consortium

Investigators

  • Study Director: Sung Yong Cho, Ph.D, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 21, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPCNL Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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