Clinical trial NCT00941551: Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
Official title: Five-year Follow up of a Randomized Clinical Trial of Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Goiter
Keywords: Thyroid lobectomy,
prophylactic levothyroxine treatment,
recurrent nodular goiter,
iodine deficiency,
long-term follow-up,
completion thyroidectomy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief 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

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 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

Primary outcomes:
measure: Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe
timeFrame: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively
Secondary outcomes:
measure: Secondary outcome was the rate of the reoperation for the recurrent goiter
timeFrame: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Study officials:
affiliation: Jagiellonian University College of Medicine
name: Marcin Barczynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/BF03346363.
citation: 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. doi: 10.1016/j.surg.2004.06.054.
citation: 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.
citation: 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. doi: 10.1111/j.1365-2265.1994.tb03926.x.
citation: 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. doi: 10.1046/j.1365-2265.2002.01628.x.