Classic Total Thyroidectomy With or Without Drains

This study has been completed.

Sponsor:

Collaborator:

AHEPA University Hospital

Information provided by:

Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT00691990

First received: June 5, 2008

Last updated: August 3, 2011

Last verified: July 2009

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

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:	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
Study Completion Date:	July 2011
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

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 Papavramidis	Trainee in Surgery
Principal Investigator:	Nikolaos Michalopoulos	Trainee in Surgery
Principal Investigator:	Georgios Gkoutzamanis	Surgeon

More Information

No publications provided

Responsible Party:	Prof. Spiros Papavramidis, 3rd Department of Surgery, AHEPA University Hospital
ClinicalTrials.gov Identifier:	NCT00691990 History of Changes
Other Study ID Numbers:	332/12_05_2008
Study First Received:	June 5, 2008
Last Updated:	August 3, 2011
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 June 13, 2013