Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery

April 7, 2009 updated by: Uppsala University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK8000
        • Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
  • Sweden
      • Lund, Sweden, SE 22185
        • Department of Surgery, Lund University Hospital
      • Uppsala, Sweden, SE75189
        • Uppsala University Hospital, Dept of surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain
Time Frame: 4 days
4 days
Operating time

Secondary Outcome Measures

Outcome Measure
Time Frame
complications
Time Frame: 6 months
6 months
Persistent or recurrent disease
Time Frame: 6 months
6 months
conversion rate
Cosmetic results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Lund University
University of Aarhus

Investigators

  • Principal Investigator: Anders Bergenfelz, MD, Ass Prof, Department of Surgery, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (ESTIMATE)

April 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2009

Last Update Submitted That Met QC Criteria

April 7, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPT02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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