Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery
Primary Purpose
Primary Hyperparathyroidism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Minimal invasive Parathyroid surgery
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring hyperparathyroidism, surgery, minimal invasive, videoassited
Eligibility Criteria
Inclusion Criteria:
- Patients with biochemically verified primary hyperparathyroidism and with an unequivocal localisation on sestamibi scintigraphy of a solitary parathyroid adenoma
Exclusion Criteria:
- Negative or equivocal preoperative localization study, familiar HPT, previous neck surgery or neck irradiation, concomitant need of thyroid surgery, pregnancy, suspected ectopic parathyroid localization, or inability to understand information, instructions and/or comply with scheduled follow-up.
Sites / Locations
- Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
- Department of Surgery, Lund University Hospital
- Uppsala University Hospital, Dept of surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Videoassited surgery
Open surgery
Arm Description
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, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy.
Outcomes
Primary Outcome Measures
Postoperative pain
Operating time
Secondary Outcome Measures
complications
Persistent or recurrent disease
conversion rate
Cosmetic results
Full Information
NCT ID
NCT00877981
First Posted
April 7, 2009
Last Updated
April 7, 2009
Sponsor
Uppsala University
Collaborators
Lund University, University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00877981
Brief Title
Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery
Official Title
Open Compared to Video-Assisted Minimal-Invasive Parathyroid Surgery in Primary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
Lund University, University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
Keywords
hyperparathyroidism, surgery, minimal invasive, videoassited
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videoassited surgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Open surgery
Arm Type
Active Comparator
Arm Description
Open surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy.
Intervention Type
Procedure
Intervention Name(s)
Minimal invasive Parathyroid surgery
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
4 days
Title
Operating time
Secondary Outcome Measure Information:
Title
complications
Time Frame
6 months
Title
Persistent or recurrent disease
Time Frame
6 months
Title
conversion rate
Title
Cosmetic results
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with biochemically verified primary hyperparathyroidism and with an unequivocal localisation on sestamibi scintigraphy of a solitary parathyroid adenoma
Exclusion Criteria:
Negative or equivocal preoperative localization study, familiar HPT, previous neck surgery or neck irradiation, concomitant need of thyroid surgery, pregnancy, suspected ectopic parathyroid localization, or inability to understand information, instructions and/or comply with scheduled follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Bergenfelz, MD, Ass Prof
Organizational Affiliation
Department of Surgery, Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK8000
Country
Denmark
Facility Name
Department of Surgery, Lund University Hospital
City
Lund
ZIP/Postal Code
SE 22185
Country
Sweden
Facility Name
Uppsala University Hospital, Dept of surgery
City
Uppsala
ZIP/Postal Code
SE75189
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
20035529
Citation
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.
Results Reference
derived
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Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery
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