Comparison of Surgical Outcomes Between MPCNL and RIRS

Not Applicable

Completed

• Conditions: Renal Stone
• Interventions: Device: RIRS; Device: MPCNL

• Registration Number: NCT02067221
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIRS (retrograde intrarenal surgery)	RIRS	Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract
MPCNL (mini-perc)	MPCNL	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

Primary Outcome Measures

Name	Time	Method
stone-free rate	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of