Long-Term Adherence to Levothyroxine Replacement Therapy in Thyroidectomized Patients.

(1) Background: We evaluated the long term adherence to two distinct formulations of levothyroxine (L-T4), liquid or solid, which are differently influenced by concomitant food ingestion. (2) Methods: A total of 106 thyroidectomized patients (82 female, mean age 58.2 ± 13.3 years) on L-T4 replacement therapy in either liquid (n = 52) or solid formulation (n = 54) were administered the four-item Medication Adherence Questionnaire (MAQ). (3) Results: The study population had 59.4% adherers and 40.6% non-adherers. The global MAQ score was significantly better in patients under liquid L-T4 in comparison to those under solid L-T4 (0.42 ± 0.82 vs. 0.83 ± 0.95, respectively, p = 0.0085). The patients on tablet L-T4 forgot to take their medication more frequently than those on liquid LT4 treatment (p = 0.0159) and were more often careless at times about taking their medication (p = 0.007), whilst about one in two thyroidectomized patients preferred tablets for lifetime medication therapy. The global MAQ score was directly correlated with the circulating TSH levels in the whole study population (0.700, p < 0.0001) and inversely correlated with both the FT3 (−0.220, p = 0.0232) and FT4 (−0.327, p = 0.0006) serum concentrations. (4) Conclusions: Long-term adherence to L-T4 treatment was globally satisfactory although it was better for the liquid formulation, which appears to represent an easier-to-manage L-T4 replacement therapy for most thyroidectomized patients, particularly for those with difficulties in taking L-T4 while fasting.

Endocrine surgery during COVID-19 pandemic: do we need an update of indications in Italy?

The ongoing spread of the coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the coronavirus outbreak began spreading, hospitals were forced to relocate resources to treat the growing number of COVID-19 patients. As a consequence, doctors across the country canceled tens of thousands of nonurgent surgeries. However, recognizing that the COVID-19 situation may be highly variable and fluid in different communities across the country, elective surgery could be still allowed in some centers for patients included in the high-priority class. The majority of endocrine disorders requiring surgical treatment in patients identifiable as first-priority class, or needing hospitalization within 30 days, are generally represented by malignant thyroid tumors, hyperthyroidism, hyperparathyroidism, and some adrenal disorders. The need for urgent intervention is evaluated on a case-by-case basis according to the severity of the symptoms, the likelihood of progression, and global clinical judgment. On the basis of the above indications, during the last 4 weeks, we performed 18 planned surgical treatments in patients with thyroid cancer (total thyroidectomies, plus lymph node dissection if needed) or multinodular toxic goiter. In no case, postoperative ventilatory support was needed, and the average hospital stay was 3 days. The negative COVID-19 status for all the treated patients was appropriately evaluated beforehand. Nobody knows how long the current COVID-19 pandemic will be lasting. Certainly, we will be requested in the next future to incrementally offer surgical services for endocrine disorders that have been deferred for the COVID-19 pandemic.

Comparative study between the effects of replacement therapy with liquid and tablet formulations of levothyroxine on mood states, self-perceived psychological well-being and thyroid hormone profile in recently thyroidectomized patients.

Following thyroid surgery, levothyroxine therapy is used to replace deficient thyroid hormones and prevent postoperative thyroid hypofunction. We compared the effects of replacement therapy with either liquid or tablet formulation of levothyroxine on mood states, self-perceived mental well-being and thyroid hormone profile in recently thyroidectomized patients. Profile of mood states, General Heath Questionnaire 12-items and thyroid hormone profile were assessed in recently (5-7 days) thyroidectomized patients at baseline and 2 months after randomization to replacement therapy with either liquid (n = 77) or tablet (n = 78) formulation of levothyroxine. After 2 months under levothyroxine replacement treatment, significant improvements of Positive Affect Scale (p < 0.001) and Negative Affect Scale (p < 0.001) of Profile of mood states, as well as of General Heath Questionnaire 12-items (p < 0.001) were observed in the study population. However, there were greater variations observed in patients assigned to liquid levothyroxine formulation in comparison to those who were assigned to levothyroxine in the form of tablet (time × treatment interaction: Positive Affect Scale of Profile of mood states, p = 0.030; Negative Affect Scale of Profile of mood states, p < 0.0001; General Heath Questionnaire 12-items, p = 0.003). As expected, circulating TSH levels significantly decreased (p <0.001) while FT3 and FT4 levels significantly increased (p < 0.0001 for both) under levothyroxine replacement therapy. These changes were significantly greater in patients treated with liquid levothyroxine formulation (time × treatment interaction: TSH, p = 0.011; FT3, p = 0.016; FT4, p = 0.028). Our data indicate a greater efficacy of liquid formulation of levothyroxine in ameliorating mood states and self-perception of mental well-being and thyroid hormone profile after 2 months of replacement therapy in recently thyroidectomized patients.

Predictive factors for recurrence after thyroid lobectomy for unilateral non-toxic goiter in an endemic area: results of a multivariate analysis.

BACKGROUND: The aim of the study was to identify the factors that are predictive of recurrence after thyroid lobectomy for unilateral non-toxic thyroid goiter in an endemic region through a multivariate analysis. METHODS: Two hundred sixty-eight consecutive patients who underwent thyroid lobectomy and who were evaluated by the same endocrinologist were included. Univariate and multivariate analysis analyzed the relationship between sex, age, preoperative thyroid-stimulating hormone, duration of disease, duration of levothyroxine (LT4) preoperative therapy, cytologic results, histologic results, resected thyroid weight, numbers and diameters of thyroid nodules, morphologic alterations of the remnant lobe, follow-up length, postoperative LT4 therapy, ultrasonographic evidence of recurrence, and reoperation. RESULTS: The incidence of recurrence was 33.9% (91/268 patients) after a mean follow-up time of 79.9 months (range, 12-251 months), female sex ( P = .016), multiple nodules ( P = .017), and lack of postoperative LT4 therapy ( P = .0009) were predictive factors of recurrence. Reoperation was performed in 20 patients (7.4%); factors that were predictive of reoperation were the presence of multiple nodules ( P = .008), resected thyroid weight ( P = .00006), and lack of postoperative hormonal therapy ( P = .0005). CONCLUSIONS: Thyroid lobectomy for unilateral non-toxic goiter, when combined with suppressive or substitutive thyroxin therapy, resulted in a low rate of recurrence and reoperation in an endemic area.

Is routine supplementation therapy (calcium and vitamin D) useful after total thyroidectomy?

BACKGROUND: Our goal was to determine whether routine oral calcium (OC) and vitamin D (VD) administration can effectively prevent symptoms of hypocalcemia after total thyroidectomy. METHODS: Seventy-nine patients who underwent total thyroidectomy were randomly allotted to one of the following groups: (1) group A, no treatment; (2) group B, OC 3 g per day; (3) group C, OC 3 g + VD 1 mg per day. Treatment was started on postoperative (PO) day 1 in groups B and C. RESULTS: Fewer patients in groups B and C experienced symptoms when compared with group A (P =.005). Patients in groups B and C had only minor symptoms, whereas 2 patients in group A experienced major symptoms and 6 required intravenous calcium (P <.01). The rate of hypocalcemia was slightly lower in group C (P = not significant). Treatment was discontinued by PO day 7 in all but 8 patients. Two patients still required treatment 6 months after operation (2.5%). PO parathyroid hormone levels did not differ in the 3 groups (P = not significant). CONCLUSIONS: Routine supplementation therapy with OC or VD effectively prevents symptomatic hypocalcemia after total thyroidectomy and may allow for a safe early discharge. Further studies are necessary to determine the best treatment. The combination of OC and VD may further reduce the rate of PO hypocalcemia, without inhibiting parathyroid hormone secretion.

Early prediction of postthyroidectomy hypocalcemia by one single iPTH measurement.

BACKGROUND: We prospectively evaluated the possibility to make an early prediction of postthyroidectomy hypocalcemia by postoperative intact parathyroid hormone (iPTH) measurements. METHODS: Fifty-three consecutive patients who underwent bilateral thyroid resection were included; iPTH was measured preoperatively, at the end of the surgical procedure, and at 2, 4, 6, 24, and 48 hours after the operation. Patients who had hypocalcemia (serum total calcium, <8.0 mg/dL) were compared with normocalcemic patients. RESULTS: Sixteen patients experienced hypocalcemia. Six patients experienced symptoms. No significant difference was found between hypocalcemic and normocalcemic patients concerning demographic, pathologic, and preoperative laboratory data, surgical procedure, and intraoperative findings. Postoperative iPTH levels were reduced in hypocalcemic patients at the end of the procedure and at 2, 4, 6, 24, and 48 hours after the operation ( P < .001). IPTH levels below the normal range (<10 pg/mL) at 4 and 6 hours after the operation correctly predicted postoperative hypocalcemia and symptoms in all but 1 patient with a self-limiting, asymptomatic hypocalcemia (serum calcium concentration, 7.8 mg/dL) (specificity, 100%; sensitivity, 94%; overall accuracy, 98%). CONCLUSIONS: One single iPTH measurement reliably can predict, early after thyroidectomy, which patients are prone to clinically relevant postoperative hypocalcemia and necessitate supplementation treatment and which patients are eligible for a safe early discharge.

Video-assisted vs conventional thyroid lobectomy: a randomized trial.

HYPOTHESIS: Video-assisted thyroid lobectomy improves the cosmetic outcome of the cutaneous scar and reduces postoperative pain. PARTICIPANTS: Patients admitted to the Division of Endocrine Surgery of the Università Cattolica del Sacro Cuore, Rome, Italy, between March 1999 and December 2000 who were candidates for thyroid lobectomy because of a single, small (< or = 3 cm) thyroid nodule were considered eligible. Of the 62 patients who were randomized, 31 underwent conventional thyroid lobectomy (COS group), and 31 underwent video-assisted surgery without carbon dioxide neck insufflation (VAS group), a new technique created by the authors. RESULTS: The cosmetic outcome was evaluated by scoring patients' satisfaction with their scars. Satisfaction was higher in the VAS group (mean +/- SD, 9.2 +/- 0.5) than the COS group (mean +/- SD, 5.8 +/- 0.7) (P<.001). Postoperative pain in the first and second days after surgery was lower in the VAS group (mean +/- SD, 1.8 +/- 0.2 and 1.2 +/- 0.1, respectively) than in the COS group (mean +/- SD, 6.2 +/- 0.2 and 5.8 +/- 0.2, respectively) (P<.001). There were no significant differences in complications (eg, bleeding, wound infection, permanent recurrent nerve palsy). Postoperative hospital stay was lower in the VAS group (mean +/- SD, 1.1 +/- 0.1 days) than in the COS group (mean +/- SD, 2.2 +/- 0.2 days) (P<.05). CONCLUSION: Video-assisted thyroid lobectomy is a valid alternative to conventional surgery in patients with single, small nodular thyroid lesions.

Video-assisted thyroidectomy.

BACKGROUND: In 1998, we developed a technique for video-assisted thyroidectomy (VAT). In this article we report on the entire series of patients who underwent VAT and discuss the results obtained. STUDY DESIGN: Forty-seven patients were selected for VAT. Eligibility criteria were: thyroid nodules of 35 mm or less in maximum diameter; estimated thyroid volume within normal range or slightly enlarged; small, low-risk papillary carcinomas; neither previous neck surgery nor irradiation; and no thyroiditis. After a learning period, VAT was proposed also for completion thyroidectomy (of previous video-assisted lobectomy) and nodules with maximum diameter up to 45 mm. The procedure is performed by a totally gasless video-assisted technique through a single 1.5- to 2.0-cm skin incision. Dissection is performed under endoscopic vision using a technique very similar to conventional operation. RESULTS: Fifty-three VATs were attempted on 47 patients. Thirty-three lobectomies, 10 total thyroidectomies, and 6 completion thyroidectomies were successfully performed. Six patients with papillary carcinoma underwent central neck lymph node removal by the same access. Mean operative time was 86.8 minutes for lobectomy, 116.0 minutes for total thyroidectomy, and 77.5 minutes for completion thyroidectomy. Conversion rate was 7.5%. Postoperative complications included one transient recurrent nerve palsy, three transient symptomatic postoperative hypocalcemias, and one wound infection. The cosmetic result was considered excellent by most of the patients who successfully underwent VAT. CONCLUSIONS: VAT is feasible and safe and allows for an excellent cosmetic result. Not all patients are eligible for this procedure, but in selected cases it can be a valid option for the surgical treatment of thyroid diseases.

Video-assisted thyroidectomy under local anesthesia.

One theoretical limit of video-assisted thyroidectomy (VAT) was the supposed necessity of general anesthesia. Herein we describe a technique for VAT performed under locoregional anesthesia. Eligibility criteria were small thyroid nodules (<2 cm) in small or normal thyroid glands (thyroid volume < or =20 mL), no previous neck surgery or irradiation, and patient motivation for local anesthesia. VAT using locoregional anesthesia was performed under a superficial cervical block. During the procedure, the patients were completely awake and able to speak with members of the surgical team. Intraoperative and postoperative pain, as evaluated by a visual analogue scale, was usually negligible. No complications occurred. Mean postoperative stay was 26 hours. All of the patients were completely satisfied with the cosmetic result, the procedure, and the surgical outcome. VAT is also feasible and safe under local anesthesia. We are optimistic about the future of this approach, which opens a new frontier for minimally invasive procedures in thyroid surgery.

Central neck lymph node removal during minimally invasive video-assisted thyroidectomy for thyroid carcinoma: a feasible and safe procedure.

BACKGROUND AND PURPOSE: In 1998, we developed a technique for video-assisted thyroidectomy (VAT) which we proposed using also in patients with small low-risk papillary thyroid carcinomas (PTC). In some cases, enlarged lymph nodes are incidentally found at surgery for PTC. These nodes should be removed because of the risk of metastases. In this paper, we report on the patients in whom we removed enlarged central neck lymph nodes during VAT for PTC and discuss the feasibility and safety of video-assisted central neck lymph node dissection (VALD). PATIENTS AND METHODS: The procedure is performed by a totally gasless video-assisted technique through a single 1.5-to 2.0-cm skin incision above the sternal notch. Dissection is performed under endoscopic vision using a technique very similar to that of conventional surgery. Only enlarged lymph nodes were removed and sent for frozen section examination (FS). No other dissection was performed in case of negative FS. Five patients underwent VALD during VAT for PTC. RESULTS: The mean number of lymph nodes removed was 2.4. No metastases were found at FS or final histology examination. Postoperative complications included two transient postoperative hypocalcemias. No evidence of residual or recurrent disease was observed at postoperative follow-up. The cosmetic result was excellent. CONCLUSION: Our experience demonstrates that removal of central compartment lymph nodes is feasible and safe. Perhaps also complete central neck lymph node dissection can be performed. Some doubts persist about the oncologic validity of this approach. For definitive conclusions, larger series and comparative studies are necessary.

Video-assisted thyroidectomy.

OBJECTIVE: In 1998, we developed a technique for video-assisted thyroidectomy (VAT). In this paper, we report on the entire series of patients who underwent VAT and discuss the results obtained. METHODS: Seventy-three patients were selected for VAT. Eligibility criteria were: thyroid nodules

Circulating thyroglobulin mRNA does not predict early and midterm recurrences in patients undergoing thyroidectomy for cancer.

BACKGROUND: The aim of the present study was to evaluate if serum Tg mRNA assay predicts recurrence in patients undergoing thyroidectomy for cancer. METHODS: Sixty-four consecutive patients undergoing surgery between April 1997 and July 1999 were studied. One year after surgery, blood samples were taken for serum thyroglobulin (Tg) immunoassay and for Tg mRNA assay by reverse transcription-polymerase chain reaction (RT-PCR). All patients underwent periodical clinical examination, including laboratory tests for serum Tg immunoassay, neck ultrasound, radioiodine scans, and treatment if indicated. Kaplan-Meier estimates of survival were calculated according to the presence or absence of circulating Tg mRNA and according to baseline Tg levels. RESULTS: Tg mRNA was detected in 14 (21.8%) of 64 patients with thyroid carcinoma. After a median follow-up of 110 months, 8 patients (12.5%) relapsed. Among patients with detectable Tg mRNA (n. 14), only 1 distant metastasis occurred (7%), whereas lymph node metastases (n = 3) or distant metastases (n = 4) were detected in 7 of 50 patients (14%) with undetectable Tg mRNA. Tumor relapse occurred in all 7 patients with increased serum Tg and only in 1 out of 57 patients (1.7%) with normal or undetectable serum Tg. The disease-free interval of patients positive at baseline for Tg mRNA was similar to that of patients with undetectable Tg mRNA at baseline. Similar results were obtained when we limited the analysis to only patients who received postsurgical radioiodine ablation. CONCLUSIONS: The results of present study suggest that detection of circulating Tg mRNA 1 year after thyroidectomy for cancer might be of no utility in predicting early and midterm local and distant recurrences.

Total thyroidectomy for management of benign thyroid disease: review of 526 cases.

Total thyroidectomy is not frequently performed in cases of benign disease because of the associated risk of postoperative hypoparathyroidism and recurrent laryngeal nerve (RLN) damage. We chose a series of patients who had undergone total thyroidectomy (TT) for benign thyroid tumors to evaluate the safety of this approach and its role in the treatment of nonmalignant lesions of the thyroid. We considered only patients with a minimum follow-up of 24 months. Records of 526 patients who underwent TT were carefully reviewed, assessing for perioperative complications and late sequelae. The mean age was 44 +/- 15.7 years; 109 patients (20.7%) were male and 417 (79.3%) were female. Altogether, 65 patients (12.3%) were operated on for toxic goiter, 429 (81.6%) for bilateral nodular goiter, and 32 (6.1%) for thyroiditis. Postoperative hemorrhage requiring reoperation occurred in 8 cases (1.5%). The incidences of permanent RLN palsy (considered as a percentage of the nerves at risk) and permanent hypocalcemia were 0.4% and 3.4%, respectively. A trend toward a decrease in the complication rate was observed during the last 5 years. There were no disease recurrences during a mean follow-up of 44 months. The results of our series show that TT can be performed safely in patients, with a low incidence of lifetime disabilities. TT has the advantage of reducing/avoiding the risk of disease recurrence and reoperation and should therefore be considered a valuable option for treating benign thyroid diseases.