Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery
NCT ID: NCT00877981
Last Updated: 2009-04-08
Study Results
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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COMPLETED
NA
143 participants
INTERVENTIONAL
2003-02-28
2007-10-31
Brief Summary
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Detailed Description
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In patients randomized to open surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy. In case of an enlarged upper parathyroid or dorsally located lower parathyroid, the incision is made anterior to the sternocleidomastoid muscle (SCM) whereas for anterior located lower parathyroids a central incision is chosen.
In patients randomized to a video-assisted approach, the surgeon has the option to choose either the lateral- (VAPLA) or medial (MIVAP) techniques, both initiated with a 15 mm transverse skin incision.
Postoperatively the patients receive a questionnaire for selfdocumentation.Variables recorded include postoperative pain, hypocalcaemic symptoms, breathing problems, cervical discomforts of pressure/globus and voice disturbances. A visual analogue scale (VAS) is used when appropriate. The intake of oral analgesics and calcium medication is also recorded. The questionnaire is used daily for the first four postoperative days, and thereafter weekly for four weeks.
Follow-up is done at 1 and 6 month after surgery, with measurement of plasma calcium and PTH. Continued needs of calcium or vitamin D medication, length of scar, and symptoms or signs of complications are recorded. At the six-month follow-up, patients document their opinion of the cosmetic results and the remaining neck discomfort using a VAS.
Primary outcome measures are postoperative pain and operation time. Secondary outcome measures are complications, persistent or recurrent disease, conversion rates and cosmetic results.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Videoassited surgery
In patients randomized to a video-assisted approach, the surgeon has the option to choose either the lateral- (VAPLA) or medial (MIVAP) techniques, both initiated with a 15 mm transverse skin incision. The lateral approach is performed as described by Henry.
The medial approach is performed using the gasless procedure developed by Miccoli.
Minimal invasive Parathyroid surgery
Open surgery
Open surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy.
Minimal invasive Parathyroid surgery
Interventions
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Minimal invasive Parathyroid surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Lund University
OTHER
University of Aarhus
OTHER
Uppsala University
OTHER
Responsible Party
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Uppsala University, Dept of Surgical Sciences
Principal Investigators
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Anders Bergenfelz, MD, Ass Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Lund University
Locations
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Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
Aarhus, , Denmark
Department of Surgery, Lund University Hospital
Lund, , Sweden
Uppsala University Hospital, Dept of surgery
Uppsala, , Sweden
Countries
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References
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Hessman O, Westerdahl J, Al-Suliman N, Christiansen P, Hellman P, Bergenfelz A. Randomized clinical trial comparing open with video-assisted minimally invasive parathyroid surgery for primary hyperparathyroidism. Br J Surg. 2010 Feb;97(2):177-84. doi: 10.1002/bjs.6810.
Other Identifiers
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HPT02
Identifier Type: -
Identifier Source: org_study_id
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