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

This study has been completed.
Sponsor:
Collaborator:
AHEPA University Hospital
Information provided by (Responsible Party):
Papavramidis Theodossis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00692835
First received: June 5, 2008
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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 August 28, 2014