Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

Recurrent Goiter Clinical Trial

Official title:

Five-year Follow up of a Randomized Clinical Trial of Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941551
• Other study ID #: BBN/501/ZKL/69/L
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: July 16, 2009
• Start date: January 2000
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2008
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Recurrent Goiter

Intervention

Drug:
• levothyroxine
levothyroxine 75-125 ug/day
• no levothyroxine
observation only without prophylactic levothyroxine

Locations

Country	Name	City	State
Poland	Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe		at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively	Yes
Secondary	Secondary outcome was the rate of the reoperation for the recurrent goiter		at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively	Yes