NCT02651818

Brief Summary

The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on the disease specific quality of life evaluated 6 months after thyroid surgery. All investigations follow already scheduled treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 30, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

January 6, 2016

Last Update Submit

May 14, 2018

Conditions

Goiter

Keywords

GoiterThyroid diseaseStruma

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life following thyroidectomy

    Change in goiter symptom score at the Thyroid specific Patient Reported Outcome measure (ThyPRO) following thyroidectomy

    6 months

Interventions

ThyroidectomyPROCEDURE

Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter

You may qualify if:

  • Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
  • The patients must be able to understand, read and write Danish

You may not qualify if:

  • Previous surgery to the neck
  • Diabetes or any neuromuscular disorders
  • Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

GoiterThyroid Diseases

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christian Godballe, Professor

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 11, 2016

Study Start

October 30, 2014

Primary Completion

October 24, 2017

Study Completion

October 24, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

DK(1)