Quality of Life in Patients Undergoing Parathyroidectomy

NCT ID: NCT00905866

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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

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Parathyroidectomy Hyperparathyroidism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Quality of life

All participants undergoing parathyroidectomy

PAS and SF-36 questionnaires

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mackay Memorial Hospital

Principal Investigators

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Shih-Ping Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

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Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 19245902 (View on PubMed)

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. doi: 10.1007/s00268-002-6623-y. Epub 2002 May 21.

Reference Type BACKGROUND
PMID: 12016473 (View on PubMed)

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. doi: 10.1067/msy.2000.108117.

Reference Type BACKGROUND
PMID: 11015085 (View on PubMed)

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. doi: 10.1111/j.1445-2197.2004.02907.x.

Reference Type BACKGROUND
PMID: 14996155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14736016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18953601 (View on PubMed)

Other Identifiers

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MMH-I-S-591

Identifier Type: -

Identifier Source: org_study_id

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