Primary HyperparathyroidismNCT00877981
Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery
A study testing Minimal invasive Parathyroid surgery in people with Primary Hyperparathyroidism, run by Uppsala University at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Minimal invasive Parathyroid surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2003to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with biochemically verified primary hyperparathyroidism and with an unequivocal localisation on sestamibi scintigraphy of a solitary parathyroid adenoma
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Department of Surgery, Lund University Hospital
Lund, SE 22185
Uppsala University Hospital, Dept of surgery
Uppsala, SE75189
Denmark1 site
Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
Aarhus, DK8000
About this study
Official title: Open Compared to Video-Assisted Minimal-Invasive Parathyroid Surgery in Primary Hyperparathyroidism
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.
Read the 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.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Minimal invasive Parathyroid surgery
- Keywords
- hyperparathyroidism, surgery, minimal invasive, videoassited
- Medical subject headings
- Hyperparathyroidism, Primary, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive Parathyroid surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimal invasive Parathyroid surgery |
| 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. Receives: Procedure: Minimal invasive Parathyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: 4 days
Operating time
Secondary outcomes (4)
complications
Measured: 6 months
Persistent or recurrent disease
Measured: 6 months
conversion rate
Cosmetic results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startFeb 2003
- Primary completionApr 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, University of Aarhus
- Investigators
- Anders Bergenfelz, MD, Ass Prof, Principal investigator, Department of Surgery, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877981
- Sponsor's protocol ID
- HPT02
- Status last verified
- Apr 2009
- First submitted
- 7 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20035529
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Compared to Video-Assisted Minimal-Invasive Parathyroid Surgery in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT00877981
- Acronym / sponsor ID
- HPT02
- Conditions
- Primary Hyperparathyroidism
- Keywords
- hyperparathyroidism, surgery, minimal invasive, videoassited
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Lund University, University of Aarhus
- Study start
- Feb 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoassited surgery | Active comparator | Procedure: Minimal invasive Parathyroid surgeryIn 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 | Procedure: Minimal invasive Parathyroid surgeryOpen surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with biochemically verified primary hyperparathyroidism and with an unequivocal localisation on sestamibi scintigraphy of a solitary parathyroid adenoma
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal invasive Parathyroid surgery | Procedure or surgery | Open surgery, Videoassited surgery |
Primary outcome
Postoperative pain
Time frame: 4 days
Operating time
4 secondary outcomes
complications
Time frame: 6 months
Persistent or recurrent disease
Time frame: 6 months
conversion rate
Cosmetic results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- Derived from this study: PubMed 20035529Hessman 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.
Related trials for Primary Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
RecruitingPhase 4
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Primary Hyperparathyroidism
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Bergenfelz, MD, Ass Prof principal investigator
Department of Surgery, Lund University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive Parathyroid surgery in people with Primary Hyperparathyroidism, run by Uppsala University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.