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Immediate Postoperative Course of Patients With Mini Video Assisted Total Thyroidectomy (miVAT) Versus Classic Total Thyroidectomy (cTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00692835
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : October 2, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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
Goiter Procedure: Total Thyroidectomy (Mini Video Assisted Thyroidectomy) Procedure: Total Thyroidectomy (Classic Thyroidectomy)

  Show Detailed Description

Study Design

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
Primary Completion Date : December 2009
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Patients with mini Video Assisted Thyroidectomy (miVAT)
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)
Procedure: Total Thyroidectomy (Classic Thyroidectomy)
Immediate postoperative course of patients with Thyroidectomy


Outcome Measures

Primary Outcome Measures :
  1. Postoperative course of patients [ Time Frame: 7 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Greece
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Greece, 55236
Sponsors and Collaborators
Aristotle University Of Thessaloniki
AHEPA University Hospital
More Information

Responsible Party: Papavramidis Theodossis, Elected lecturer, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00692835     History of Changes
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

Keywords provided by Papavramidis Theodossis, Aristotle University Of Thessaloniki:
Goiter [C19.874.283]
Thyroid Neoplasms [C19.874.788]

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases