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| Name | Class |
|---|---|
| Lund University | OTHER |
| University of Aarhus | OTHER |
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The aim of the present study was to compare open minimal-invasive parathyroid surgery with video-assisted parathyroidectomy in primary hyperparathyroidism (PHPT) patients with a positive sestamibi scan in a multicentre randomized trial in order to evaluate if videoassisted surgery gave less postoperative pain and if there was a difference in operating time.
The present study is designed to compare open minimal-invasive parathyroid surgery with video-assisted parathyroidectomy in pHPT patients with a positive sestamibi scan in a multicentre prospective randomized trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videoassited surgery | Active Comparator | 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. |
|
| Open surgery | Active Comparator | Open surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal invasive Parathyroid surgery | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | 4 days | |
| Operating time |
| Measure | Description | Time Frame |
|---|---|---|
| complications | 6 months | |
| Persistent or recurrent disease | 6 months | |
| conversion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Bergenfelz, MD, Ass Prof | Department of Surgery, Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital | Aarhus | DK8000 | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20035529 | Derived | 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. |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Cosmetic results |
| Department of Surgery, Lund University Hospital |
| Lund |
| SE 22185 |
| Sweden |
| Uppsala University Hospital, Dept of surgery | Uppsala | SE75189 | Sweden |