NCT01637337

Brief Summary

To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with \>3cm renal pelvis stone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

July 3, 2012

Last Update Submit

April 19, 2016

Conditions

Renal Pelvis Stone >3cm

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    at least 6 month after surgery

Study Arms (2)

laparoscopic pyelolithotomy

ACTIVE COMPARATOR
Procedure: laparoscopic pyelolithotomy

percutaneous nephrolithotomy

SHAM COMPARATOR
Procedure: percutaneous nephrolithotomy

Interventions

laparoscopic pyelolithotomyPROCEDURE

laparoscopy

laparoscopic pyelolithotomy
percutaneous nephrolithotomyPROCEDURE

percutaneous nephrolithotomy

percutaneous nephrolithotomy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with \>3cm renal pelvis stone

You may not qualify if:

  • History of previous surgery on the target kidney
  • Active UTI
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, 71344, Iran

Location

MeSH Terms

Interventions

Nephrolithotomy, Percutaneous

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 11, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IR(1)