Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
Information source: Jagiellonian University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Goiter
Intervention: levothyroxine (Drug); no levothyroxine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Jagiellonian University Official(s) and/or principal investigator(s): Marcin Barczynski, MD, PhD, Principal Investigator, Affiliation: Jagiellonian University College of Medicine
Summary
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
Clinical Details
Official title: Five-year Follow up of a Randomized Clinical Trial of Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe
Secondary outcome: Secondary outcome was the rate of the reoperation for the recurrent goiter
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery, Krakow 31-202, Poland
Additional Information
Related publications: Szybinski Z, Golkowski F, Buziak-Bereza M, Trofimiuk M, Przybylik-Mazurek E, Huszno B, Bandurska-Stankiewicz E, Bar-Andziak E, Dorant B, Kinalska I, Lewinski A, Klencki M, Rybakowa M, Sowinski J, Szewczyk L, Szponar L, Wasik R. Effectiveness of the iodine prophylaxis model adopted in Poland. J Endocrinol Invest. 2008 Apr;31(4):309-13. Bellantone R, Lombardi CP, Boscherini M, Raffaelli M, Tondolo V, Alesina PF, Corsello SM, Fintini D, Bossola M. Predictive factors for recurrence after thyroid lobectomy for unilateral non-toxic goiter in an endemic area: results of a multivariate analysis. Surgery. 2004 Dec;136(6):1247-51. Miccoli P, Antonelli A, Iacconi P, Alberti B, Gambuzza C, Baschieri L. Prospective, randomized, double-blind study about effectiveness of levothyroxine suppressive therapy in prevention of recurrence after operation: result at the third year of follow-up. Surgery. 1993 Dec;114(6):1097-101; discussion 1101-2. Bistrup C, Nielsen JD, Gregersen G, Franch P. Preventive effect of levothyroxine in patients operated for non-toxic goitre: a randomized trial of one hundred patients with nine years follow-up. Clin Endocrinol (Oxf). 1994 Mar;40(3):323-7. Carella C, Mazziotti G, Rotondi M, Del Buono A, Zito G, Sorvillo F, Manganella G, Santini L, Amato G. Iodized salt improves the effectiveness of L-thyroxine therapy after surgery for nontoxic goitre: a prospective and randomized study. Clin Endocrinol (Oxf). 2002 Oct;57(4):507-13.
Starting date: January 2000
Last updated: July 16, 2009
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