Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolot... | NCT01637337

Studies
Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolothotomy for Management of >3cm Renal Pelvis Stone

NCT01637337

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Apr 20, 2016Estimated

Enrollment

60Actual

Phase

Phase 2Phase 3

Conditions

Renal Pelvis Stone >3cm

Interventions

laparoscopic pyelolithotomy
percutaneous nephrolithotomy

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alireza Aminsharifi, Assistant Professor of Urology, Shiraz University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic pyelolithotomy	Active Comparator		Procedure: laparoscopic pyelolithotomy
percutaneous nephrolithotomy	Sham Comparator		Procedure: percutaneous nephrolithotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic pyelolithotomy	Procedure	laparoscopy	laparoscopic pyelolithotomy

Measure	Description	Time Frame
Stone free rate		at least 6 month after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with >3cm renal pelvis stone

Exclusion Criteria:

History of previous surgery on the target kidney
Active UTI
Coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University of Medical Sciences		Shiraz	Fars	71344	Iran

Intervention Browse Module

MeSH Terms

ID	Term
D000074642	Nephrolithotomy, Percutaneous

Ancestor Terms

ID	Term
D010535	Laparoscopy
D004724	Endoscopy
D019060	Minimally Invasive Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided