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

This study has been completed.
Sponsor:
Collaborator:
AHEPA University Hospital
Information provided by (Responsible Party):
Papavramidis Theodossis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00693147
First received: June 5, 2008
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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 Intervention
Goiter
Procedure: Total Thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Comparison of the late postoperative course and complications of the patients using the two techniques [ Time Frame: 6months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2008
Study Completion Date: September 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 5, 2008
Last Updated: September 29, 2012
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014