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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
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring hyperparathyroidism, surgery, minimal invasive, videoassited

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 7, 2009
Last Updated
April 7, 2009
Sponsor
Uppsala University
Collaborators
Lund University, University of Aarhus
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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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