NCT02430168

Brief Summary

Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 22, 2015

Last Update Submit

April 29, 2015

Conditions

Kidney Stones

Keywords

StoneRIRsPCNLPain

Outcome Measures

Primary Outcomes (2)

  • Analgesic demand

    Postoperative 24 hours

  • Stone clearance

    3 months

Study Arms (2)

RIRS

ACTIVE COMPARATOR

Retrograde intrarenal surgery

Procedure: Retrograde intrarenal surgery

PCNL

ACTIVE COMPARATOR

Percutaneous nephrolithotomy

Procedure: Percutaneous nephrolithotomy

Interventions

Percutaneous nephrolithotomyPROCEDURE
Also known as: PCNL
PCNL
Retrograde intrarenal surgeryPROCEDURE
Also known as: RIRS
RIRS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who have 2 to 4 cm kidney stones
  • ASA score within 1 to 3

You may not qualify if:

  • Previous surgical treatment including SWL
  • Congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi TRH

Ankara, 06110, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.

    PMID: 22093679RESULT

  • Soderberg L, Ergun O, Ding M, Parker R, Borofsky MS, Pais V, Dahm P. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults. Cochrane Database Syst Rev. 2023 Nov 13;11(11):CD013445. doi: 10.1002/14651858.CD013445.pub2.

    PMID: 37955353DERIVED

MeSH Terms

Conditions

Kidney CalculiCalculiPain

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Nihat Karakoyunlu

CONTACT

00905324747134nkarakoyunlu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 22, 2015

First Posted

April 30, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

TU(1)