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Completed

NCT Number: NCT02067221

Comparison of Surgical Outcomes Between MPCNL and RIRS

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SMG-SNU Boramae Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RIRS

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

Other names: retrograde intrerenal surgery

MPCNL

Device
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. pain

    Time frame: postoperative 1 day

    Visual analogue scale will be measured: 0 (no pain) -> 10 (the most worst pain ever experienced)

  2. hemoglobin drop

    Time frame: postoperative 1 day

    preoperative Hb level - Hb level of immediate postoperative 1 day

  3. 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

  4. hospital stay

    Time frame: postoperative 1 month

    calculation of days of hospital stay

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • SK Telecom Consortium

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2014
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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