Surgical Approach for Primary Hyperparathyroidism in the Elderly

This study is currently recruiting participants.
Verified June 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01484379
First received: December 1, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly.

This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.


Condition Intervention
Multigland Disease in Primary Hyperparathyroidism
Procedure: unilateral neck exploration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Frequency of multigland disease in hyperparathyroidism in the elderly. [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: elderly with primary hyperparathyroidism Procedure: unilateral neck exploration
All elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with primary hyperparathyroidism.
  • patients with an indication for surgery.
  • Suspected adenoma on preop images.
  • minimum age of 65.

Exclusion Criteria:

  • patients younger than 65.
  • cases where imaging didn't locate any adenoma.
  • patients who did not consent to participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484379

Contacts
Contact: Michal Mekel, M.D 972-48541309 m_mekel@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Michal Mekel, M.D    972-48541309    m_mekel@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Michal Mekel, M.D Rambam health care campus Haifa Israel
  More Information

Publications:
Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01484379     History of Changes
Other Study ID Numbers: parathyroid409-11-RMBCTIL
Study First Received: December 1, 2011
Last Updated: June 19, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Primary Hyperparathyroidism
multigland disease
neck exploration
elderly

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014