Quality of Life in Patients Undergoing Parathyroidectomy

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00905866
Collaborator
(none)
60
1
35
1.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: PAS and SF-36 questionnaires

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

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation of Quality of Life in Patients Undergoing Parathyroidectomy
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism [1 year]

Secondary Outcome Measures

  1. To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in patients undergoing parathyroidectomy [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mackay Memorial Hospital Taipei Taiwan 10449

Sponsors and Collaborators

  • Mackay Memorial Hospital

Investigators

  • Principal Investigator: Shih-Ping Cheng, MD, Mackay Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00905866
Other Study ID Numbers:
  • MMH-I-S-591
First Posted:
May 21, 2009
Last Update Posted:
Jul 22, 2011
Last Verified:
Jul 1, 2011
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2011