Comparison of Surgical Outcomes Between MPCNL and RIRS

Renal Stone Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067221
• Other study ID #: MPCNL Study
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: June 21, 2015
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

Device:
• RIRS
RIRS arm Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
• MPCNL
MPCNL arm A new technique that reduced the size of percutaneous tract to make renal stone into small pieces.

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SK Telecom Consortium

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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