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

NCT00693147 | Completed DMC

• 1 other identifier: 334/12-05-2008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Goiter

Keywords

Goiter [C19.874.283]; Thyroid Neoplasms [C19.874.788]

Outcome Measures

Primary Outcomes (1)

• Comparison of the late postoperative course and complications of the patients using the two techniques

  6months

Study Arms (2)

A

ACTIVE COMPARATOR

mini Video Assisted Thyroidectomy (miVAT)

Procedure: Total Thyroidectomy

B

ACTIVE COMPARATOR

Classic Total Thyroidectomy

Procedure: Total Thyroidectomy

Interventions

Total Thyroidectomy PROCEDURE

Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• AHEPA University Hospital: collaborator

Study Sites (1)

3rd Department of Surgery, AHEPA University Hospital

Thessaloniki, Thessaloniki, 55236, Greece

Location

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Spiros Papavramidis, Prof

  Director of the 3rd department of surgery

  STUDY CHAIR

• Kostantinos Sapalidis

  Surgeon

  STUDY DIRECTOR

• Theodossis S Papavramidis

  Trainee in Surgery

  PRINCIPAL INVESTIGATOR

• Nikolaos Michalopoulos

  Trainee in Surgery

  PRINCIPAL INVESTIGATOR

• Georgios Gkoutzamanis

  Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elected lecturer

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 6, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

GR (1)