NCT02430883

Brief Summary

We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery

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
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 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

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

April 27, 2015

Last Update Submit

April 27, 2015

Conditions

Nephrolithiasis

Keywords

pain, RIRS, kidney

Outcome Measures

Primary Outcomes (1)

  • Pain degree

    Pain degree postoperative 24 hours

Study Arms (5)

first group

ACTIVE COMPARATOR

patients who have upper pole kidney stones treated with flexible renoscopy

Procedure: Retrograde Intrarenal Surgery

second group

ACTIVE COMPARATOR

patients u who have mid pole kidney stones treated with flexible renoscopy

Procedure: Retrograde Intrarenal Surgery

third group

ACTIVE COMPARATOR

patients who have lower pole kidney stones treated with flexible renoscopy

Procedure: Retrograde Intrarenal Surgery

forth group

ACTIVE COMPARATOR

patients who have kidney stones in pelvis treated with flexible renoscopy

Procedure: Retrograde Intrarenal Surgery

fifth group

ACTIVE COMPARATOR

patients who have multiple calixes kidney stones treated with flexible renoscopy

Procedure: Retrograde Intrarenal Surgery

Interventions

Retrograde Intrarenal SurgeryPROCEDURE

endoscopic treatment of kidney stones with flexible renoscopy

fifth groupfirst groupforth groupsecond groupthird group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing RIRS Age between 18 and 90 years

You may not qualify if:

  • Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dıskapı TRH

Ankara, 06110, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Polito C, La Manna A, Signoriello G, Marte A. Recurrent abdominal pain in childhood urolithiasis. Pediatrics. 2009 Dec;124(6):e1088-94. doi: 10.1542/peds.2009-0825. Epub 2009 Nov 9.

    PMID: 19901004RESULT

MeSH Terms

Conditions

NephrolithiasisPain

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

TU(1)