Immediate Postoperative Course of Patients With Mini Video Assisted Total Thyroidectomy (miVAT) Versus Classic Total Thyroidectomy (cTT)
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ClinicalTrials.gov Identifier: NCT00692835 |
Recruitment Status :
Completed
First Posted : June 6, 2008
Last Update Posted : October 2, 2012
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Goiter | Procedure: Total Thyroidectomy (Mini Video Assisted Thyroidectomy) Procedure: Total Thyroidectomy (Classic Thyroidectomy) | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Immediate Postoperative Course of Patients With Mini Video Assisted Total Thyroidectomy (miVAT) Versus Classic Total Thyroidectomy (cTT) |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | September 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: A
Patients with mini Video Assisted Thyroidectomy (miVAT)
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Procedure: Total Thyroidectomy (Mini Video Assisted Thyroidectomy)
Immediate postoperative course of patients with Thyroidectomy |
Active Comparator: B
Immediate postoperative course of patients with classic Thyroidectomy (cTT)
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Procedure: Total Thyroidectomy (Classic Thyroidectomy)
Immediate postoperative course of patients with Thyroidectomy |
- Postoperative course of patients [ Time Frame: 7 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is over 18 years old
- Patient scheduled for a non-emergency operation
- Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Exclusion Criteria:
- Patient had a previous operation at the thyroid
- Patient is participating in another clinical trial which may affect this study's outcomes
- Patient in toxic condition (non euthyroid or hypothyroid )
- Patient receiving anticoagulation treatment for other medical condition
- Echographic evidence that the size at least one nodule is more than 4cm

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692835
Greece | |
3rd Department of Surgery, AHEPA University Hospital | |
Thessaloniki, Greece, 55236 |
Responsible Party: | Papavramidis Theodossis, Elected lecturer, Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00692835 |
Other Study ID Numbers: |
333/12-5-2008 |
First Posted: | June 6, 2008 Key Record Dates |
Last Update Posted: | October 2, 2012 |
Last Verified: | September 2012 |
Goiter [C19.874.283] Thyroid Neoplasms [C19.874.788] |
Goiter Thyroid Diseases Endocrine System Diseases |