Surgical Approach for Primary Hyperparathyroidism in the Elderly

NCT ID: NCT01484379

Last Updated: 2017-08-25

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multigland Disease in Primary Hyperparathyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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unilateral neck exploration

unilateral neck exploration of elderly with primary hyperparathyroidism

Group Type EXPERIMENTAL

unilateral neck exploration

Intervention Type PROCEDURE

All elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal Mekel, M.D

Role: PRINCIPAL_INVESTIGATOR

Rambam health care campus Haifa Israel

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 12912745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19476894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1413850 (View on PubMed)

Other Identifiers

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parathyroid409-11-RMBCTIL

Identifier Type: -

Identifier Source: org_study_id

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