Quality of Life in Patients Undergoing Parathyroidectomy

Hyperparathyroidism Clinical Trial

Official title:

Evaluation of Quality of Life in Patients Undergoing Parathyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905866
• Other study ID #: MMH-I-S-591
• Status: Completed
• Phase: N/A
• First received: May 18, 2009
• Last updated: July 20, 2011
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Parathyroidectomy

Intervention

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

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

Cheng 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. — View Citation

Chow 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. — View Citation

Greutelaers 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. — View Citation

Pasieka 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. Epub 2002 May 21. — View Citation

Pasieka 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism		1 year	No
Secondary	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	No