ParathyroidectomyNCT00205452
Quality of Life (QOL) Following Parathyroid Surgery
An observational study of Parathyroidectomy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroidectomy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing parathyroid surgery
Who may be able to join
- parathyroidectomy
Who cannot join
- subjects under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: 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.
- Conditions
- Parathyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParathyroidectomyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert Chen, MD, Principal investigator, University of Wisconsin Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205452
- Sponsor's protocol ID
- 2003-164
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 18 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Quality of Life Improve Following Minimally Invasive Parathyroid Surgery?
- ClinicalTrials.gov ID
- NCT00205452
- Acronym / sponsor ID
- 2003-164
- Conditions
- Parathyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing parathyroid surgery
Key inclusion criteria (1 listed)
- parathyroidectomy
Key exclusion criteria (1 listed)
- subjects under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Chen, MD principal investigator
University of Wisconsin Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parathyroidectomy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.