Classic Total Thyroidectomy With or Without Drains

This study is currently recruiting participants.

Verified by Aristotle University Of Thessaloniki, June 2008

Sponsors and Collaborators:	Aristotle University Of Thessaloniki AHEPA University Hospital
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT00691990

Purpose

Protocol Synopsis

Design: Prospective, single-center randomized study Patient Population: Male or female subjects 18 years of age or older who are scheduled for total thyroidectomy
No. of Subjects: 100 patients divided into two groups, estimated up to 6 months 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

Drug Information available for: Thyroid

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Classic Total Thyroidectomy With or Without Drains

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

Assess the necessity of the use of drains in large goiters [ Time Frame: 7days ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
A: Active Comparator Classic thyroidectomy with drains	Procedure: Total thyroidectomy Comparison of the safety and cost-effectiveness of classic thyroidectomy with or without drains
B: Active Comparator Classic thyroidectomy without drains	Procedure: Total thyroidectomy Comparison of the safety and cost-effectiveness of classic thyroidectomy with or without drains

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 thyroid operation
Patient is participating in another clinical trial which may affect this study's outcomes
Patient in toxic condition
Patient receiving anticoagulation treatment for other medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691990

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

Investigators

Study Chair:	Spiros Papavramidis, Prof	Director of the 3rd department of surgery
Study Director:	Kostantinos Sapalidis	Surgeon
Principal Investigator:	Theodossis Papavramidis	Trainee in Surgery
Principal Investigator:	Nikolaos Michalopoulos	Trainee in Surgery
Principal Investigator:	Georgios Gkoutzamanis	Surgeon

More Information

Responsible Party:	3rd Department of Surgery, AHEPA University Hospital ( Prof. Spiros Papavramidis )
Study ID Numbers:	332/12_05_2008
Study First Received:	June 5, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00691990
Health Authority:	Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:

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

Study placed in the following topic categories:

Goiter
Thyroid Neoplasms
Endocrine System Diseases
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on January 15, 2009