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Nephrolithiasis and Bariatric Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00169793
First received: September 9, 2005
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Nephrolithiasis
 Other: evaluation of kidney stone risk after bariatric surgery
Other: Evaluate risk of kidney stones after bariatric surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Nephrolithiasis and Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • To quantify the prevalence of stone disease among patients at the Clarian Hospitals who have had BSP between 3 and 3.5 years previously. [ Time Frame: In the next two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify clinical and laboratory risk factors for incident nephrolithiasis following bariatric surgery. [ Time Frame: In the next two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: August 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Other: evaluation of kidney stone risk after bariatric surgery
24 hour urine collections done pre and post surgery
Other Name: observation
Other: Evaluate risk of kidney stones after bariatric surgery
24 hour urine collections are done before and after surgery
Other Name: observation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169793

Locations
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Kidney Stone Institute
Indiana University School of Medicine
Investigators
Principal Investigator: James E. Lingeman, MD Methodist Urology, LLC
  More Information

Additional Information:
click here to view other studies being done by Methodist Urology  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00169793     History of Changes
Other Study ID Numbers: 05-076
Study First Received: September 9, 2005
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:
Obesity
Nephrolithiasis

Additional relevant MeSH terms:
Obesity
Nephrolithiasis
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on May 23, 2013