ParathyroidectomyNCT00905866
Quality of Life in Patients Undergoing Parathyroidectomy
An observational study of Parathyroidectomy and Hyperparathyroidism, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
There are three specific aims in the present study: 1. To validate the investigators' translated version of parathyroidectomy assessment of symptoms (PAS) questionnaire. 2. To evaluate the impact of parathyroidectomy on health-related quality of life in the investigators' patients with hyperparathyroidism. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroidectomy, Hyperparathyroidism
- What is being tested?
- PAS and SF-36 questionnaires
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Jul 2011
- 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: All patients underwent parathyroidectomy
Who may be able to join
- Aged 18 and older
Who cannot join
- Subjects who are illiterate or unable to complete questionnaire
- Excluded by patient's clinician prior to recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Quality of Life in Patients Undergoing Parathyroidectomy
There are three specific aims in the present study:
- To validate the investigators' translated version of parathyroidectomy assessment of symptoms (PAS) questionnaire.
- To evaluate the impact of parathyroidectomy on health-related quality of life in the investigators' patients with hyperparathyroidism.
- To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in the investigators' patients.
Read the detailed description
Either primary or secondary hyperparathyroidism may necessitate parathyroidectomy in some patients to improve the related biochemical abnormalities or symptoms, or both. Many patients diagnosed with hyperparathyroidism today do not have the classic or historical severe manifestations such as osteitis fibrosa cystica or nephrocalcinosis. The well-known pentad of symptoms - painful bones, kidney stones, abdominal groans, psychic moans, and fatigue overtones - is more common, although most patients have few dramatic symptoms. The multifactorial causes for many of the symptoms that patients have make it difficult to know to what extent surgical intervention will alleviate the symptoms. Several endocrine surgeons from the western countries have used a standardized health status assessment tool such as the SF-36 (the Medical Outcomes Study Short-Form Health Survey) to assess symptoms and health state in patients with hyperparathyroidism. Results of the studies confirmed that these patients are indeed impaired in several domains and even seemingly "asymptomatic" patients benefit from parathyroidectomy. More recently, Canadian surgeon Pasieka designed and validated a disease-specific surgical outcome tool, the parathyroidectomy assessment of symptoms (PAS) score, for patients with hyperparathyroidism. Using this tool, several studies from different countries showed that the study group of patients with hyperparathyroidism had significantly more symptoms than controls, and some of the symptoms are remarkably ameliorated after surgery. In Taiwan, only a small number of studies have evaluated neuropsychiatric function and neuromuscular abnormalities in these patients. None of the studies has used a patient-based measure of health status or quality of life intended to capture patient-reported perceptions of health and function.
- Conditions
- Parathyroidectomy, Hyperparathyroidism
- Being tested
- PAS and SF-36 questionnaires
- Keywords
- Quality of life, Hyperparathyroidism
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS and SF-36 questionnairesOther
Patients who agree to participate in this study will be asked to fill out a translated PAS questionnaire and a Taiwan version of SF-36 before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Quality of life | All participants undergoing parathyroidectomy Receives: Other: PAS and SF-36 questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism
Measured: 1 year
Secondary outcomes (1)
To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in patients undergoing parathyroidectomy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ParathyroidectomyStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Ping Cheng, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905866
- Sponsor's protocol ID
- MMH-I-S-591
- Status last verified
- Jul 2011
- First submitted
- 18 May 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adler JT, Sippel RS, Schaefer S, Chen H. Surgery improves quality of life in patients with "mild" hyperparathyroidism. Am J Surg. 2009 Mar;197(3):284-90. doi: 10.1016/j.amjsurg.2008.09.009.
PubMed 19245902Pasieka JL, Parsons LL, Demeure MJ, Wilson S, Malycha P, Jones J, Krzywda B. Patient-based surgical outcome tool demonstrating alleviation of symptoms following parathyroidectomy in patients with primary hyperparathyroidism. World J Surg. 2002 Aug;26(8):942-9. doi: 10.1007/s00268-002-6623-y. Epub 2002 May 21.
PubMed 12016473Pasieka JL, Parsons LL. A prospective surgical outcome study assessing the impact of parathyroidectomy on symptoms in patients with secondary and tertiary hyperparathyroidism. Surgery. 2000 Oct;128(4):531-9. doi: 10.1067/msy.2000.108117.
PubMed 11015085Greutelaers B, Kullen K, Kollias J, Bochner M, Roberts A, Wittert G, Pasieka J, Malycha P. Pasieka Illness Questionnaire: its value in primary hyperparathyroidism. ANZ J Surg. 2004 Mar;74(3):112-5. doi: 10.1111/j.1445-2197.2004.02907.x.
PubMed 14996155Chow KM, Szeto CC, Kum LC, Kwan BC, Fung TM, Wong TY, Leung CB, Li PK. Improved health-related quality of life and left ventricular hypertrophy among dialysis patients treated with parathyroidectomy. J Nephrol. 2003 Nov-Dec;16(6):878-85.
PubMed 14736016Cheng SP, Liu CL, Chen HH, Lee JJ, Liu TP, Yang TL. Prolonged hospital stay after parathyroidectomy for secondary hyperparathyroidism. World J Surg. 2009 Jan;33(1):72-9. doi: 10.1007/s00268-008-9787-2.
PubMed 18953601
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life in Patients Undergoing Parathyroidectomy
- ClinicalTrials.gov ID
- NCT00905866
- Acronym / sponsor ID
- MMH-I-S-591
- Conditions
- Parathyroidectomy, Hyperparathyroidism
- Keywords
- Quality of life, Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 May 2009 (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.
There are three specific aims in the present study:
- To validate the investigators' translated version of parathyroidectomy assessment of symptoms (PAS) questionnaire.
- To evaluate the impact of parathyroidectomy on health-related quality of life in the investigators' patients with hyperparathyroidism.
- To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in the investigators' patients.
Detailed description
Either primary or secondary hyperparathyroidism may necessitate parathyroidectomy in some patients to improve the related biochemical abnormalities or symptoms, or both. Many patients diagnosed with hyperparathyroidism today do not have the classic or historical severe manifestations such as osteitis fibrosa cystica or nephrocalcinosis. The well-known pentad of symptoms - painful bones, kidney stones, abdominal groans, psychic moans, and fatigue overtones - is more common, although most patients have few dramatic symptoms. The multifactorial causes for many of the symptoms that patients have make it difficult to know to what extent surgical intervention will alleviate the symptoms. Several endocrine surgeons from the western countries have used a standardized health status assessment tool such as the SF-36 (the Medical Outcomes Study Short-Form Health Survey) to assess symptoms and health state in patients with hyperparathyroidism. Results of the studies confirmed that these patients are indeed impaired in several domains and even seemingly "asymptomatic" patients benefit from parathyroidectomy. More recently, Canadian surgeon Pasieka designed and validated a disease-specific surgical outcome tool, the parathyroidectomy assessment of symptoms (PAS) score, for patients with hyperparathyroidism. Using this tool, several studies from different countries showed that the study group of patients with hyperparathyroidism had significantly more symptoms than controls, and some of the symptoms are remarkably ameliorated after surgery. In Taiwan, only a small number of studies have evaluated neuropsychiatric function and neuromuscular abnormalities in these patients. None of the studies has used a patient-based measure of health status or quality of life intended to capture patient-reported perceptions of health and function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life | – | Other: PAS and SF-36 questionnairesAll participants undergoing parathyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients underwent parathyroidectomy
Key inclusion criteria (1 listed)
- Aged 18 and older
Key exclusion criteria (2 listed)
- Subjects who are illiterate or unable to complete questionnaire
- Excluded by patient's clinician prior to recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAS and SF-36 questionnairesPatients who agree to participate in this study will be asked to fill out a translated PAS questionnaire and a Taiwan version of SF-36 before and after surgery | Other | Quality of life |
Primary outcome
To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism
Time frame: 1 year
1 secondary outcome
To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in patients undergoing parathyroidectomy
Time frame: 1 year
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 22 Jul 2011.
- Background: PubMed 19245902Adler JT, Sippel RS, Schaefer S, Chen H. Surgery improves quality of life in patients with "mild" hyperparathyroidism. Am J Surg. 2009 Mar;197(3):284-90. doi: 10.1016/j.amjsurg.2008.09.009.
- Background: PubMed 12016473Pasieka JL, Parsons LL, Demeure MJ, Wilson S, Malycha P, Jones J, Krzywda B. Patient-based surgical outcome tool demonstrating alleviation of symptoms following parathyroidectomy in patients with primary hyperparathyroidism. World J Surg. 2002 Aug;26(8):942-9. doi: 10.1007/s00268-002-6623-y. Epub 2002 May 21.
- Background: PubMed 11015085Pasieka JL, Parsons LL. A prospective surgical outcome study assessing the impact of parathyroidectomy on symptoms in patients with secondary and tertiary hyperparathyroidism. Surgery. 2000 Oct;128(4):531-9. doi: 10.1067/msy.2000.108117.
- Background: PubMed 14996155Greutelaers B, Kullen K, Kollias J, Bochner M, Roberts A, Wittert G, Pasieka J, Malycha P. Pasieka Illness Questionnaire: its value in primary hyperparathyroidism. ANZ J Surg. 2004 Mar;74(3):112-5. doi: 10.1111/j.1445-2197.2004.02907.x.
- Background: PubMed 14736016Chow KM, Szeto CC, Kum LC, Kwan BC, Fung TM, Wong TY, Leung CB, Li PK. Improved health-related quality of life and left ventricular hypertrophy among dialysis patients treated with parathyroidectomy. J Nephrol. 2003 Nov-Dec;16(6):878-85.
- Background: PubMed 18953601Cheng SP, Liu CL, Chen HH, Lee JJ, Liu TP, Yang TL. Prolonged hospital stay after parathyroidectomy for secondary hyperparathyroidism. World J Surg. 2009 Jan;33(1):72-9. doi: 10.1007/s00268-008-9787-2.
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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.
Shih-Ping Cheng, MD principal investigator
Mackay Memorial Hospital
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 and Hyperparathyroidism, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 2 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 22 Jul 2011. 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 Taiwan. 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.
What does the primary outcome measure?
To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00905866, which also lists 6 linked publications.
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 22 Jul 2011.