Quality of Life (QOL) Following Parathyroid Surgery
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 16, 2012 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00205452 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life (QOL) Following Parathyroid Surgery | ||||
| Official Title ICMJE | Does Quality of Life Improve Following Minimally Invasive Parathyroid Surgery? | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects undergoing parathyroid surgery |
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| Condition ICMJE | Parathyroidectomy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00205452 | ||||
| Other Study ID Numbers ICMJE | 2003-164 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University of Wisconsin, Madison | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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