Goiter Clinical Trial
Official title:
Immediate Postoperative Course of Patients With Mini Video Assisted Total Thyroidectomy (miVAT) Versus Classic Total Thyroidectomy (cTT)
Verified date | September 2012 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
Protocol Synopsis
- Protocol title: Immediate postoperative course of patients with mini Video Assisted
Thyroidectomy (miVAT) versus classic Thyroidectomy (cTT)
- Purpose: Comparison of the immediate postoperative course and complications of the
patients using the two techniques
- Design: Prospective, single-center randomized study
- Patient Population: Male or female subjects 18 years of age or older with nodular
goiter who are scheduled for total thyroidectomy (miVAT or T)
- No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll
- Duration of Treatment: During the operation
- Duration of Follow-up: Follow-up will be performed daily while hospitalized, and by
phone till the 7th postoperative day
- Endpoints: To evaluate the safety and cost-effectiveness of each technique
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2012 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient is over 18 years old 2. Patient scheduled for a non-emergency operation 3. Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures Exclusion Criteria: 1. Patient had a previous operation at the thyroid 2. Patient is participating in another clinical trial which may affect this study's outcomes 3. Patient in toxic condition (non euthyroid or hypothyroid ) 4. Patient receiving anticoagulation treatment for other medical condition 5. Echographic evidence that the size at least one nodule is more than 4cm |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | 3rd Department of Surgery, AHEPA University Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki | AHEPA University Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative course of patients | 7 days | Yes |
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