NCT00691990

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2009

Enrollment Period

1.6 years

First QC Date

June 5, 2008

Last Update Submit

August 3, 2011

Conditions

Goiter

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Assess the necessity of the use of drains in large goiters

    7days

Study Arms (2)

A

ACTIVE COMPARATOR

Classic thyroidectomy with drains

Procedure: Total thyroidectomy

B

ACTIVE COMPARATOR

Classic thyroidectomy without drains

Procedure: Total thyroidectomy

Interventions

Total thyroidectomyPROCEDURE

Comparison of the safety and cost-effectiveness of classic thyroidectomy with or without drains

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3rd Department of Surgery, AHEPA University Hospital

Thessaloniki, Thessaloniki, 55236, Greece

Location

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Spiros Papavramidis, Prof

    Director of the 3rd department of surgery

    STUDY CHAIR

  • Kostantinos Sapalidis

    Surgeon

    STUDY DIRECTOR

  • Theodossis 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

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

July 1, 2011

Last Updated

August 4, 2011

Record last verified: 2009-07

Locations

GR(1)