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Surgical Approach for Primary Hyperparathyroidism in the Elderly

Primary Purpose

Multigland Disease in Primary Hyperparathyroidism

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
unilateral neck exploration
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multigland Disease in Primary Hyperparathyroidism focused on measuring Primary Hyperparathyroidism, multigland disease, neck exploration, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

unilateral neck exploration

Arm Description

unilateral neck exploration of elderly with primary hyperparathyroidism

Outcomes

Primary Outcome Measures

Frequency of multigland disease in hyperparathyroidism in the elderly.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2011
Last Updated
August 24, 2017
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01484379
Brief Title
Surgical Approach for Primary Hyperparathyroidism in the Elderly
Official Title
Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
difficulties in Recruiting patients
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multigland Disease in Primary Hyperparathyroidism
Keywords
Primary Hyperparathyroidism, multigland disease, neck exploration, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unilateral neck exploration
Arm Type
Experimental
Arm Description
unilateral neck exploration of elderly with primary hyperparathyroidism
Intervention Type
Procedure
Intervention Name(s)
unilateral neck exploration
Intervention Description
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 Measure Information:
Title
Frequency of multigland disease in hyperparathyroidism in the elderly.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Mekel, M.D
Organizational Affiliation
Rambam health care campus Haifa Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
12912745
Citation
Kebebew E, Duh QY, Clark OH. Parathyroidectomy for primary hyperparathyroidism in octogenarians and nonagenarians: a plea for early surgical referral. Arch Surg. 2003 Aug;138(8):867-71. doi: 10.1001/archsurg.138.8.867.
Results Reference
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PubMed Identifier
19476894
Citation
Shin SH, Holmes H, Bao R, Jimenez C, Kee SS, Potylchansky E, Lee JE, Evans DB, Perrier ND. Outpatient minimally invasive parathyroidectomy is safe for elderly patients. J Am Coll Surg. 2009 Jun;208(6):1071-6. doi: 10.1016/j.jamcollsurg.2009.01.048. Epub 2009 Apr 17.
Results Reference
background
PubMed Identifier
1413850
Citation
Uden P, Chan A, Duh QY, Siperstein A, Clark OH. Primary hyperparathyroidism in younger and older patients: symptoms and outcome of surgery. World J Surg. 1992 Jul-Aug;16(4):791-7; discussion 798. doi: 10.1007/BF02067389.
Results Reference
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Surgical Approach for Primary Hyperparathyroidism in the Elderly

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