Predictors of postoperative hypocalcemia occurring after a total thyroidectomy: results of prospective multicenter study.

BACKGROUND: Thyroid surgeries are among the most common operations performed in the world. Hypocalcemia following total thyroidectomy is a common complication that is sometimes difficult to correct. The aim of this study is to determine the risk factors for hypocalcemia following total thyroidectomy and their clinical value. METHODS: From January 2015 through to April 2017, 400 patients were included in this prospective multicenter study. All patients underwent total thyroidectomy due to various thyroid diseases. The following risk factors were analyzed: pre-operative and post-operative biochemical blood parameters, clinical effects and factors related to surgery, the patient, and the disease. RESULTS: Post-operative hypocalcemia developed in 257 patients (64.2%). Of them, 197 patients (76.7%) were diagnosed with asymptomatic hypocalcemia. Clinical symptoms were present in 60 of the 257 patients with hypocalcemia (23.3%). The statistically significant predictors of hypocalcemia were decreased calcium and ionized calcium pre-operatively (p < 0.001), parathyroid hormone on day one following surgery (p < 0.001), thyrotoxicosis <10 years before surgery (odds ratio 1.65, 95% CI 1.01-2.70, p = 0.046), the number of parathyroid glands found during surgery (odds ratio 0.52, 95% CI 0.38-0.70, p < 0.001), ligation of the trunk of the left inferior thyroid artery (odds ratio 2.04, 95% CI 1.27-3.29, p = 0.003), ligation of the trunk of the right inferior thyroid artery (odds ratio 2.37, 95% CI 1.47-3.81, p < 0.001), and the number of transplanted parathyroid glands (odds ratio 1.87, 95% CI 1.12-2.97, p = 0.015). In the multivariate analysis, age (odds ratio 1.05, 95% CI 1.01-1.09, p = 0.029) and gender (odds ratio 5.94, 95% CI 1.13-31.26, p = 0.035) were statistically significant predictors. CONCLUSIONS: This study demonstrates that there is a number of different patient (gender, age, and duration of thyrotoxicosis <10 years before surgery) and surgical (number of parathyroid glands found during surgery, decreased calcium and ionized calcium before surgery, parathyroid hormone on day one following surgery, and ligation of the trunk of the left and right inferior thyroid artery) risk factors predictive of hypocalcemia following total thyroidectomy. Optimization of the surgical technique could possibly prevent the occurrence of hypocalcemia after total thyroidectomy in some cases; in other cases, identification of known risk factors post-operatively could permit early detection and effective treatment of these patients.

Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial: A Randomized Clinical Trial.

Importance: Eravacycline is a novel, fully synthetic fluorocycline antibiotic of the tetracycline class with in vitro activity against clinically important gram-negative, gram-positive aerobic, and facultative bacteria including most of those resistant to cephalosporins, fluoroquinolones, ß-lactam/ß-lactamase inhibitors, multidrug resistant strains and carbapenem-resistant Enterobacteriaceae, and most anaerobic pathogens. Objective: To evaluate the efficacy and safety of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs). Design, Setting, and Participants: This was a phase III, randomized, double-blind, multicenter study that evaluated the efficacy and safety of eravacycline in comparison with ertapenem in patients with cIAI requiring surgical or percutaneous intervention. The test-of-cure evaluation was conducted 25 to 31 days after the first dose of the study drug and the follow-up visit was conducted 38 to 50 days after the first dose of the study drug. All patients recruited into this study were hospitalized. Five hundred forty-one patients were recruited for this study; 270 patients were randomized to receive eravacycline, and 271 patients were randomized to receive ertapenem. Patients had to meet all of the following criteria: hospitalized for cIAI requiring intervention; 18 years or older; evidence of systemic inflammatory response; pain caused by cIAI; able to provide informed consent; and diagnosis of cIAI with sonogram or radiographic imaging or visual confirmation. Analyses were done in intent-to-treat and evaluable populations. Interventions: Patients received eravacycline, 1.0 mg/kg every 12 hours, or ertapenem, 1.0 g every 24 hours, for a minimum of four 24-hour dosing cycles. Main Outcomes and Measures: Clinical outcome assessments were made at the end of treatment, test of cure, and follow-up visits and were classified as clinical cure, clinical failure, or indeterminate/missing. Results: In total, 541 patients were randomly assigned to treatment: 270 in the eravacycline group and 271 in the ertapenem group. The mean ages were 54.9 years and 55.4 years for the eravacycline and ertapenem groups, respectively. Most patients were white (263 of 270 patients [97.4%] in the eravacycline group and 260 of 271 patients [95.9%] in the ertapenem group). For the microbiological intent-to-treat population, the rates of clinical cure at the test-of-cure visit were 86.8% in the eravacycline group and 87.6% in the ertapenem group. The difference in clinical cure rates between the groups was -0.80% (95% CI, -7.1% to 5.5%), meeting the prespecified noninferiority margin and allowing for statistical noninferiority of eravacycline to ertapenem to be declared for this study. Both study drugs were well tolerated. Conclusions and Relevance: Overall, eravacycline demonstrated noninferiority to ertapenem for the treatment of patients with cIAI. Trial Registration: Clinicaltrials.gov Identifier: NCT01844856.

Focused versus conventional parathyroidectomy for primary hyperparathyroidism: a prospective, randomized, blinded trial.

BACKGROUND: For many years bilateral neck exploration (BNE) was the gold standard operation for primary hyperparathyroidism (pPHP). With advances in preoperative pathological gland localization and intraoperative parathyroid hormone (IPTH) monitoring, minimally invasive approaches have evolved. This study is aimed to compare BNE and focused parathyroidectomy (FP) in a prospective, randomized, blind trial. PATIENTS AND METHODS: Between 2005 and 2007, 48 patients with pPHP were enrolled in our study. Twenty three patients were randomized to the BNE group and 24 to the FP group. Patients in the FP group underwent preoperative localization studies. All parathyroidectomies were guided by intraoperative intact parathyroid hormone (IIPTH) monitoring. In the BNE group, neither IIPTH nor preoperative localization studies were performed. RESULTS: All patients were cured by the primary operation. Overall, the operative time was similar in both groups. In the focused exploration (FE) group, compared to the BNE group, there was lower pain intensity at 4, 8, 16, 24, 36 and 48 h after surgery (p < 0.001), lower consumption of analgesics (p < 0.001), lower analgesia request rate (p < 0.001), shorter scar length (p < 0.001), higher cosmetic satisfaction rate 2 days, 1 month (p < 0.001) and 6 months after surgery (p < 0.05), but after 1 year cosmetic satisfaction rate became not significant (p = 0.38). Focused exploration (FE) was more expensive (p < 0.05). We did not find any difference in quality of life after 1 month and 6 months after surgery in both groups. CONCLUSION: Both methods of parathyroidectomy for PHP are safe and effective. Focused exploration (FE) has several advantages: lower postoperative pain, lower analgesic request rate, lower analgesic consumption, shorter scar length, better cosmetic satisfaction rate in a short time period.