Clinical trial NCT00877981: 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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperparathyroidism
Keywords: hyperparathyroidism
surgery
minimal invasive
videoassited
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Lund University
name: University of Aarhus
First posted: 2009-04-08
Enrollment: 143
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative pain
timeFrame: 4 days
measure: Operating time
Secondary outcomes:
measure: complications
timeFrame: 6 months
measure: Persistent or recurrent disease
timeFrame: 6 months
measure: conversion rate
measure: Cosmetic results
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital
city: Lund
country: Sweden
facility: Department of Surgery, Lund University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Dept of surgery
Study officials:
affiliation: Department of Surgery, Lund University
name: Anders Bergenfelz, MD, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.