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

This study is currently recruiting participants.

Verified by Aristotle University Of Thessaloniki, July 2009

First Received: June 5, 2008 Last Updated: July 27, 2009 History of Changes

Sponsor:	Aristotle University Of Thessaloniki
Collaborator:	AHEPA University Hospital
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT00692835

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immediate Postoperative Course of Patients With Mini Video Assisted Total Thyroidectomy (miVAT) Versus Classic Total Thyroidectomy (cTT)

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 ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Patients with mini Video Assisted Thyroidectomy (miVAT)	Procedure: Total Thyroidectomy (Mini Video Assisted Thyroidectomy) Immediate postoperative course of patients with Thyroidectomy
B: Active Comparator Immediate postoperative course of patients with classic Thyroidectomy (cTT)	Procedure: Total Thyroidectomy (Classic Thyroidectomy) Immediate postoperative course of patients with Thyroidectomy

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692835

Contacts

Contact: Theodossis S Papavramidis, M.D

+306944536972

Locations

Greece
3rd Department of Surgery, AHEPA University Hospital	Recruiting
Thessaloniki, Greece, 55236
Contact: Spiros T Papavramidis, Prof +306974405013 spapavra@med.auth.gr
Principal Investigator: Theodossis S Papavramidis, M.D
Principal Investigator: Kostantinos Sapalidis, M.D, PhD
Principal Investigator: Nikolaos Michalopoulos, M.D
Principal Investigator: Georgios Gkoutzamanis, M.D, PhD

Sponsors and Collaborators

Aristotle University Of Thessaloniki

AHEPA University Hospital

More Information

No publications provided

Responsible Party:	3rd Department of Surgery, AHEPA University Hospital ( Prof. Spiros Papavramidis )
Study ID Numbers:	333/12-5-2008
Study First Received:	June 5, 2008
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00692835 History of Changes
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
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on February 08, 2010