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Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)

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ClinicalTrials.gov Identifier: NCT00693147
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : October 2, 2012
Sponsor:
Collaborator:
AHEPA University Hospital
Information provided by (Responsible Party):
Papavramidis Theodossis, Aristotle University Of Thessaloniki

Brief Summary:

Protocol Synopsis

  • Protocol title: Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)
  • Purpose: Comparison of the late 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 by evaluation at the 3rd and 6th postoperative month ±5 days
  • Endpoints: To evaluate the long term safety of each technique

Condition or disease Intervention/treatment Phase
Goiter Procedure: Total Thyroidectomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)
Study Start Date : May 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: A
mini Video Assisted Thyroidectomy (miVAT)
Procedure: Total Thyroidectomy
Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)

Active Comparator: B
Classic Total Thyroidectomy
Procedure: Total Thyroidectomy
Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)




Primary Outcome Measures :
  1. Comparison of the late postoperative course and complications of the patients using the two techniques [ Time Frame: 6months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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): NCT00693147


Locations
Greece
3rd Department of Surgery, AHEPA University Hospital
Thessaloniki, Greece, 55236
Sponsors and Collaborators
Aristotle University Of Thessaloniki
AHEPA University Hospital
Investigators
Study Chair: Spiros Papavramidis, Prof Director of the 3rd department of surgery
Study Director: Kostantinos Sapalidis Surgeon
Principal Investigator: Theodossis S Papavramidis Trainee in Surgery
Principal Investigator: Nikolaos Michalopoulos Trainee in Surgery
Principal Investigator: Georgios Gkoutzamanis Surgeon

Responsible Party: Papavramidis Theodossis, Elected lecturer, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00693147     History of Changes
Other Study ID Numbers: 334/12-05-2008
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