Clinical Trials Directory

Trials / Completed

CompletedNCT00905866

Quality of Life in Patients Undergoing Parathyroidectomy

Evaluation of Quality of Life in Patients Undergoing Parathyroidectomy

Status
Completed
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Mackay Memorial Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERPAS 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

Timeline

Start date
2008-08-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2009-05-21
Last updated
2011-07-22

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT00905866. Inclusion in this directory is not an endorsement.