Quality of Life in Patients Undergoing Parathyroidectomy

This study has been completed.
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00905866
First received: May 18, 2009
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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. To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in the investigators' patients.

Condition Intervention
Parathyroidectomy
Hyperparathyroidism
Other: PAS and SF-36 questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Quality of Life in Patients Undergoing Parathyroidectomy

Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Quality of life
All participants undergoing parathyroidectomy
Other: PAS and SF-36 questionnaires
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients underwent parathyroidectomy

Criteria

Inclusion Criteria:

  • Aged 18 and older

Exclusion Criteria:

  • Subjects who are illiterate or unable to complete questionnaire
  • Excluded by patient's clinician prior to recruitment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905866

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Shih-Ping Cheng, MD Mackay Memorial Hospital
  More Information

Publications:
Responsible Party: Shih-Ping Cheng, MD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT00905866     History of Changes
Other Study ID Numbers: MMH-I-S-591
Study First Received: May 18, 2009
Last Updated: July 20, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Mackay Memorial Hospital:
Quality of life
Hyperparathyroidism

Additional relevant MeSH terms:
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014