NCT00877981

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

4.2 years

First QC Date

April 7, 2009

Last Update Submit

April 7, 2009

Conditions

Primary Hyperparathyroidism

Keywords

hyperparathyroidismsurgeryminimal invasivevideoassited

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    4 days

  • Operating time

Secondary Outcomes (4)

  • complications

    6 months

  • Persistent or recurrent disease

    6 months

  • conversion rate

  • Cosmetic results

Study Arms (2)

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.

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.

Procedure: Minimal invasive Parathyroid surgery

Interventions

Minimal invasive Parathyroid surgeryPROCEDURE
Open surgeryVideoassited surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with biochemically verified primary hyperparathyroidism and with an unequivocal localisation on sestamibi scintigraphy of a solitary parathyroid adenoma

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unit of Breast and Endocrine Surgery, Surgical Department P, Aarhus University Hospital

Aarhus, DK8000, Denmark

Location

Department of Surgery, Lund University Hospital

Lund, SE 22185, Sweden

Location

Uppsala University Hospital, Dept of surgery

Uppsala, SE75189, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 20035529DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryHyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Officials

  • Anders Bergenfelz, MD, Ass Prof

    Department of Surgery, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

February 1, 2003

Primary Completion

April 1, 2007

Study Completion

October 1, 2007

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

DK(1)SE(2)