Comparison of Surgical Outcomes Between MPCNL and RIRS

NCT02067221 | Completed DMC

• 1 other identifier: MPCNL Study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Stone

Keywords

percutaneous nephrolithotomy; renal calculi; ureteroscopy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• pain

  postoperative 1 day

• hemoglobin drop

  postoperative 1 day

• occurrence of complications

  postoperative 1 day, and the postop 1month at OPD

• hospital stay

  postoperative 1 month

Study Arms (2)

RIRS (retrograde intrarenal surgery)

ACTIVE COMPARATOR

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

Device: RIRS

MPCNL (mini-perc)

EXPERIMENTAL

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

Interventions

RIRS DEVICE

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

Also known as: retrograde intrerenal surgery

RIRS (retrograde intrarenal surgery)

MPCNL DEVICE

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

Also known as: minimally invasive percuntaneous nephrolithotomy, mini-perc

MPCNL (mini-perc)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SK Telecom Consortium: collaborator

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sung Yong Cho, Ph.D

  SMG-SNU Boramae Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 20, 2014
• Study Start: May 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

KR (1)