Laparoscopic Pyeloplasty Registry and Database

NCT00169650 | Completed

• 1 other identifier: 03-048
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Obstruction

Keywords

UPJ Obstruction; Renal Obstruction; Delayed Renal Flow

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

Registry and database of subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction

Other: Registry and database

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Ureteral Obstruction

Interventions

Registries

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James E Lingeman, MD

  IU Health Physicians Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2003
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

US (1)