Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery

This study has been completed.
Sponsor:
Collaborators:
Lund University
University of Aarhus
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00877981
First received: April 7, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Primary Hyperparathyroidism
Procedure: Minimal invasive Parathyroid surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Open Compared to Video-Assisted Minimal-Invasive Parathyroid Surgery in Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Operating time [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Persistent or recurrent disease [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • conversion rate [ Designated as safety issue: No ]
  • Cosmetic results [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: February 2003
Study Completion Date: October 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

Procedure: Minimal invasive Parathyroid surgery
Active Comparator: Open surgery
Open surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy.
Procedure: Minimal invasive Parathyroid surgery

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877981

Locations
Denmark
Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
Aarhus, Denmark, DK8000
Sweden
Department of Surgery, Lund University Hospital
Lund, Sweden, SE 22185
Uppsala University Hospital, Dept of surgery
Uppsala, Sweden, SE75189
Sponsors and Collaborators
Uppsala University
Lund University
University of Aarhus
Investigators
Principal Investigator: Anders Bergenfelz, MD, Ass Prof Department of Surgery, Lund University
  More Information

No publications provided

Responsible Party: Ola Hessman, Uppsala University, Dept of Surgical Sciences
ClinicalTrials.gov Identifier: NCT00877981     History of Changes
Other Study ID Numbers: HPT02
Study First Received: April 7, 2009
Last Updated: April 7, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University:
hyperparathyroidism
surgery
minimal invasive
videoassited

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014