NCT00169793

Brief Summary

Test the hypothesis that the new bariatric surgical procedures (BSP) increase stone risk, and will result in an increased incidence and prevalence of stone disease; the purpose is to determine if BSP patients require special management for stone prevention. This study does not include the bariatric surgery but enrolls subjects who are already scheduled for surgery with an affiliated surgeon. The study procedure is to collect 24 hour urines pre-and post surgically to evaluate the risk of kidney stone procedure after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable obesity

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

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

4.3 years

First QC Date

September 9, 2005

Last Update Submit

March 4, 2014

Conditions

ObesityNephrolithiasis

Keywords

ObesityNephrolithiasis

Outcome Measures

Primary Outcomes (1)

  • To quantify the prevalence of stone disease among patients at the Clarian Hospitals who have had BSP between 3 and 3.5 years previously.

    In the next two years

Secondary Outcomes (1)

  • To identify clinical and laboratory risk factors for incident nephrolithiasis following bariatric surgery.

    In the next two years

Study Arms (1)

A

OTHER
Other: evaluation of kidney stone risk after bariatric surgeryOther: Evaluate risk of kidney stones after bariatric surgery

Interventions

evaluation of kidney stone risk after bariatric surgeryOTHER

24 hour urine collections done pre and post surgery

Also known as: observation
A
Evaluate risk of kidney stones after bariatric surgeryOTHER

24 hour urine collections are done before and after surgery

Also known as: observation
A

Eligibility Criteria

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

You may qualify if:

  • Already scheduled to undergo bariatric surgery with a Clarian affiliated surgeon in Indianapolis, IN
  • Over the age of 18
  • Able to give informed consent
  • Able to comply with 24 hour urine collections at specified times

You may not qualify if:

  • Not scheduled for bariatric surgery
  • Bariatric surgery to be done by a non-Clarian affiliated surgeon
  • Unable to give informed consent
  • Unwilling/unable to comply with 24 hour urine collections at specified times

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

ObesityNephrolithiasis

Interventions

Observation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • James E. Lingeman, MD

    Methodist Urology, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

US(1)