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Surgical Approach for Primary Hyperparathyroidism in the Elderly

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ClinicalTrials.gov Identifier: NCT01484379
Recruitment Status : Withdrawn (difficulties in Recruiting patients)
First Posted : December 2, 2011
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

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 or disease Intervention/treatment Phase
Multigland Disease in Primary Hyperparathyroidism Procedure: unilateral neck exploration Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study
Study Start Date : December 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Experimental: unilateral neck exploration
unilateral neck exploration of 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.



Primary Outcome Measures :
  1. Frequency of multigland disease in hyperparathyroidism in the elderly. [ Time Frame: two years ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484379


Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Michal Mekel, M.D Rambam health care campus Haifa Israel