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Comparison of Surgical Outcomes Between MPCNL and RIRS

Primary Purpose

Renal Stone

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RIRS
MPCNL
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone focused on measuring percutaneous nephrolithotomy, renal calculi, ureteroscopy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RIRS (retrograde intrarenal surgery)

MPCNL (mini-perc)

Arm Description

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

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

Outcomes

Primary Outcome Measures

stone-free rate
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2014
Last Updated
June 21, 2015
Sponsor
Seoul National University Hospital
Collaborators
SK Telecom Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT02067221
Brief Title
Comparison of Surgical Outcomes Between MPCNL and RIRS
Official Title
Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
SK Telecom Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone
Keywords
percutaneous nephrolithotomy, renal calculi, ureteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIRS (retrograde intrarenal surgery)
Arm Type
Active Comparator
Arm Description
Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
Arm Title
MPCNL (mini-perc)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
RIRS
Other Intervention Name(s)
retrograde intrerenal surgery
Intervention Description
RIRS arm Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
Intervention Type
Device
Intervention Name(s)
MPCNL
Other Intervention Name(s)
minimally invasive percuntaneous nephrolithotomy, mini-perc
Intervention Description
MPCNL arm A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.
Primary Outcome Measure Information:
Title
stone-free rate
Description
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.
Time Frame
postoperative 1 month
Secondary Outcome Measure Information:
Title
pain
Description
Visual analogue scale will be measured: 0 (no pain) -> 10 (the most worst pain ever experienced)
Time Frame
postoperative 1 day
Title
hemoglobin drop
Description
preoperative Hb level - Hb level of immediate postoperative 1 day
Time Frame
postoperative 1 day
Title
occurrence of complications
Description
occurrence of stricture in non-contrast CT scan history taking of hematuria or fever
Time Frame
postoperative 1 day, and the postop 1month at OPD
Title
hospital stay
Description
calculation of days of hospital stay
Time Frame
postoperative 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Yong Cho, Ph.D
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparison of Surgical Outcomes Between MPCNL and RIRS

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