NCT00905866

Brief Summary

There are three specific aims in the present study:

  1. 1.To validate the investigators' translated version of parathyroidectomy assessment of symptoms (PAS) questionnaire.
  2. 2.To evaluate the impact of parathyroidectomy on health-related quality of life in the investigators' patients with hyperparathyroidism.
  3. 3.To analyze the association between clinical variables and the presentation/severity of symptoms (and/or quality of life domains) in the investigators' patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

2.9 years

First QC Date

May 18, 2009

Last Update Submit

July 20, 2011

Conditions

ParathyroidectomyHyperparathyroidism

Keywords

Quality of lifeHyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • To evaluate the impact of parathyroidectomy on health-related quality of life in patients with hyperparathyroidism

    1 year

Secondary Outcomes (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

Study Arms (1)

Quality of life

All participants undergoing parathyroidectomy

Other: PAS and SF-36 questionnaires

Interventions

PAS and SF-36 questionnairesOTHER

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

Quality of life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients underwent parathyroidectomy

You may qualify if:

  • Aged 18 and older

You may not qualify if:

  • Subjects who are illiterate or unable to complete questionnaire
  • Excluded by patient's clinician prior to recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Related 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.

    PMID: 19245902BACKGROUND

  • 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.

    PMID: 12016473BACKGROUND

  • 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.

    PMID: 11015085BACKGROUND

  • 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.

    PMID: 14996155BACKGROUND

  • 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.

    PMID: 14736016BACKGROUND

  • 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.

    PMID: 18953601BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Officials

  • Shih-Ping Cheng, MD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 21, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

TW(1)