Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00941551
First received: July 16, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

The aim of this study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment postoperatively in a five-year follow-up of a randomized study


Condition Intervention
Recurrent Goiter
Drug: levothyroxine
Drug: no levothyroxine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Five-year Follow up of a Randomized Clinical Trial of Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe [ Time Frame: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome was the rate of the reoperation for the recurrent goiter [ Time Frame: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: January 2000
Study Completion Date: December 2008
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
receiving levothyroxine postoperatively
Drug: levothyroxine
levothyroxine 75-125 ug/day
Other Name: LT4(+)
Group B
not-receiving levothyroxine postoperatively
Drug: no levothyroxine
observation only without prophylactic levothyroxine
Other Name: LT4(-)

Detailed Description:

It is commonly accepted that in patients with benign nodular thyroid disease who undergo operative therapy, surgical resection consists of lobectomy for patients with disease limited to one lobe. Contralateral disease is excluded in such cases by preoperative palpation, ultrasonography of the neck, and intraoperative palpation. On the other hand, the preferred operative procedure for bilateral nodular thyroid disease is total thyroidectomy. Such a treatment strategy minimizes the risk of development of recurrent disease and diminishes the risk of complications when reoperation for recurrent nodular thyroid disease becomes necessary. The recurrence rate for unilateral thyroidectomy of benign nodular goiter performed by expert surgeons has been reported to vary from 10% to 26%. Potential risk factors for recurrence of nodular goiter have been evaluated in many studies and include: young age at presentation, female gender, positive family history of goiter, long duration of symptoms, mutinodularity of thyroid disease, high volume of left thyroid tissue. However, most studies evaluating the incidence of recurrent nodular disease are retrospective, and it is difficult to determine whether the recurrence represents de novo nodule formation in a previously normal thyroid remnant or progression of residual disease left at initial operation.

It is well known fact, that most patients after thyroid lobectomy are euthyroid (60%-90%) and do not require thyroid hormone replacement therapy. However, it is an important question whether thyroid hormone administration postoperatively can prevent recurrent nodular thyroid disease in euthyroid hemithyroidectomized patients? The aim of the present randomized study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter (MNG) receiving versus not receiving prophylactic levothyroxine (LT4) treatment postoperatively in a five-year follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • unilateral multinodular goiter with normal appearing on ultrasound of the neck contralateral thyroid lobe, in a patient in euthyroid state

Exclusion Criteria:

  • bilateral multinodular goiter, enlargement of contralateral thyroid lobe (volume on ultrasound >10 ml), suspicion of thyroid cancer, previous thyroid surgery, thyroiditis, subclinical or clinically overt hypothyroidism or hyperthyroidism, pregnancy or lactation, age < 18 years or > 65 years, ASA 4 grade (American Society of Anesthesiology), and inability to comply with the follow-up protocol
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00941551

Locations
Poland
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Krakow, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University College of Medicine
  More Information

Publications:
Responsible Party: Piotr Laider / Head of the Biomedical Research Committee of the Jagiellonian University, Jagiellonian University medical College
ClinicalTrials.gov Identifier: NCT00941551     History of Changes
Other Study ID Numbers: BBN/501/ZKL/69/L
Study First Received: July 16, 2009
Last Updated: July 16, 2009
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
Thyroid lobectomy,
prophylactic levothyroxine treatment,
recurrent nodular goiter,
iodine deficiency,
long-term follow-up,
completion thyroidectomy

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014