- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00205452
Quality of Life (QOL) Following Parathyroid Surgery
October 16, 2012 updated by: University of Wisconsin, Madison
Does Quality of Life Improve Following Minimally Invasive Parathyroid Surgery?
The only established treatment for the complete resolution of hyperparathyroidism is the surgical removal of the affected glands.
While proven as a means of resolving hyperparathyroidism, there have been no comprehensive preoperative and postoperative assessments to determine quality of life for patients undergoing minimally invasive vs. traditional parathyroid surgery.
Quality of life will be assessed in subjects undergoing minimally invasive procedures and traditional procedures using a clinically validated survey.
We will gather data one week preoperatively as well as one week and one year postoperatively then compare the survey results from the two study groups to each other.
We will also compare the study groups to a control group consisting of patients undergoing thyroid surgery.
Our ultimate goal is to clarify if minimally invasive parathyroid surgery techniques contribute to a higher patient quality of life as compared to traditional techniques.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects undergoing parathyroid surgery
Description
Inclusion Criteria:
- parathyroidectomy
Exclusion Criteria:
- subjects under the age of 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Herbert Chen, MD, University of Wisconsin Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
October 18, 2012
Last Update Submitted That Met QC Criteria
October 16, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 2003-164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.