Laparoscopic Pyeloplasty Registry and Database | NCT00169650

Studies
Laparoscopic Pyeloplasty Registry and Database

NCT00169650

Sponsor

Indiana Kidney Stone Institute

Status

Completed

Last Update Posted

Feb 16, 2017Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Ureteral Obstruction

Interventions

Registry and database

Countries

United States

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

Feb 2017

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

Jul 2003

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

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

Feb 14, 2017

Last Update Posted Date

Feb 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The gold standard for the treatment of ureteropelvic junction obstruction (UPJO) is the open pyeloplasty. As a minimally invasive alternative, many centers are currently offering laparoscopic pyeloplasty (LP) as primary therapy for UPJOs. Recent data has shown that laparoscopic pyeloplasty has comparable success rates to open pyeloplasties and produces durable results. The researchers are compiling a registry and database to review outcomes of laparoscopic pyeloplasty patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Registry and database of subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction	Other: Registry and database

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Registry and database	Other	Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction at Methodist Urology in Indiana will be asked to participate in a registry and database to review outcomes of the surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To record and review the surgical outcomes of our population of UPJO patients who have been treated with LP. Once all retrospective data has been reviewed, we will continue to collect outcome data on a prospective basis		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients of Methodist Urology in Indianapolis, IN over the age of 18 with ureteropelvic junction obstruction

Exclusion Criteria:

Patients unable to give informed consent
Patients with active bleeding diatheses
Women who are pregnant or in whom pregnancy status cannot be confirmed
Patients with medical conditions precluding laparoscopy
Patients with active urinary tract infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James E Lingeman, MD	IU Health Physicians Urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IU Health Methodist Hospital		Indianapolis	Indiana	46202	United States

Condition Browse Module

MeSH Terms

ID	Term
D014517	Ureteral Obstruction

Ancestor Terms

ID	Term
D014515	Ureteral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012042	Registries

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D011996	Records

Browse Leaves

Not provided

Browse Branches

Not provided