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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

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

ClinicalTrials.gov processed this record on November 27, 2014