Trans oral endoscopic thyroidectomy (TOETVA): First French experience in 90 patients.

OBJECTIVE: Thyroidectomy techniques using extracervical approaches have grown in popularity for about 20 years and their feasibility has now been demonstrated. We wanted to evaluate one of these new approaches: the anterior vestibular endoscopic approach (TOETVA). The aim of this study was to evaluate the results of an initial series patients who underwent an anterior trans-vestibular endoscopic oral thyroidectomy. METHODS: From February 2018 to September 2020, this technique was offered to patients aged 18 to 70, ASA I or II, who presented with an indication for thyroid surgery and who wished to avoid cervical scars. The approach was through the anterior vestibule of the mouth and the specimen was extracted either transorally or via the axilla depending on its size. Apart from the first ten cases, all patients underwent recurrent nerve neuromonitoring. The patients were operated on by two surgeons experienced in thyroid surgery. All the patients had follow-up visits on D15, D30 and at 2 months. The pre- and intra-operative data, length of stay and complications were evaluated. RESULTS: A total of 90 consecutive patients (87 women) aged 46±12.4 years (18 to 69) with a mean BMI of 24.4±4 were included. The indications for surgery included 11 papillary cancers, 5 oncocytic nodules, 15 toxic nodules, 13 cases of Graves disease and 46 symptomatic goiters and/or nodules. The mean pre-operative diameter of the nodules was 3.61±1.99 (0.44 to 7.3) cm. The interventions performed were 44 lobo-isthmectomies, 41 total thyroidectomies and 5 isthmectomies. The mean operating time was 134±45min (40 to 255). On D1, the post-operative ionized calcium was 1.09±0.11mmol/L (4.3685±0.44mg/dL) (normal 0.8-1.15mmol/L) (3.206-4.609mg/dL)) and the total serum calcium was 2.07±0.11mmol/L 8.296±0.44mg/dL (normal 2.2-2.5mmol/L) (8.817-10.019mg/dL). Five patients underwent conversion from endoscopic to open cervical approach (5.5%). The complications were seven cases of transient recurrent nerve palsy (7.8%), eight cases of hypoparathyroidism (19%) including six transient and two permanent, one skin burn and 26 cases of transient chin numbness related to the electrocautery (29%). Ten patients (11%) presented with transient post-operative skin ecchymosis that resolved within 7-10 days. A spontaneous pneumo-mediastinum was observed on chest CT in three patients and evolved favorably. No hematoma, or surgical site infection, or complications related to axillary extraction were observed. All the patients declared themselves satisfied post-operatively and at the end of the follow-up. CONCLUSION: The TOETVA route of entry is a safe and reliable technique in well-selected patients wishing to avoid a cervical scar.

Initially untreated fasting hyperglycaemia in early pregnancy: prognosis according to occurrence of gestational diabetes mellitus after 22 weeks' gestation: a case-control study.

AIMS: To evaluate the percentage of women with untreated fasting hyperglycaemia in early pregnancy who develop gestational diabetes mellitus after 22 weeks' gestation, the determinants of gestational diabetes development in such women and the prognosis of early fasting hyperglycaemia according to whether the women go on to develop gestational diabetes. METHODS: From a large cohort of women who delivered in our hospital between 2012 and 2016, we retrospectively selected all those who had untreated early fasting hyperglycaemia and separated them into a 'gestational diabetes' and a 'no-gestational diabetes' group according to oral glucose tolerance test results after 22 weeks' gestation. We compared the incidence of a predefined composite outcome (preeclampsia or large-for-gestational-age infant or shoulder dystocia or neonatal hypoglycaemia) in both groups. RESULTS: A total of 268 women (mean fasting plasma glucose 5.3 ± 0.3 mmol/l at a mean ± sd of 10.2 ± 4.2 weeks' gestation) were included. Gestational diabetes developed in 134 women and was independently associated with early fasting plasma glucose ≥ 5.5 mmol/l [odds ratio 3.16 (95% CI 1.57, 6.33)], age ≥ 30 years [odds ratio 2.78 (95% CI 1.46, 5.31)], preconception obesity [odds ratio 2.12 (95% CI 1.11, 4.02)], family history of diabetes [odds ratio 1.87 (95% CI 1.00, 3.50)] and current employment [odds ratio 0.46 (95% CI 0.26, 0.83)]. Despite treatment, gestational diabetes induced a significant increase in the composite outcome as compared to no gestational diabetes (odds ratio 2.16 [95% CI 1.08, 4.34]). The association disappeared after adjustment for risk factors. CONCLUSIONS: Only half of the women with early fasting hyperglycaemia and no specific care subsequently developed gestational diabetes, and these women had a poor prognosis despite gestational diabetes treatment. Poor prognosis was mostly attributable to risk factors. Our results suggest that only women with certain risk factors should be screened for early fasting hyperglycaemia.

Performance of a selective screening strategy for diagnosis of hyperglycaemia in pregnancy as defined by IADPSG/WHO criteria.

AIM: Our study evaluated the performance of a selective screening strategy for hyperglycaemia in pregnancy (HIP) based on the presence of risk factors (RFs; body mass index≥25kg/m2, age≥35years, family history of diabetes, personal history of HIP or macrosomic infant) to diagnose HIP and to predict HIP-related events. METHODS: Women with no known diabetes who had undergone complete universal screening (early, before 22weeks of gestation and, if normal, in the second part of pregnancy) at our department (2012-2016) were selected, resulting in four groups of women according to the presence of HIP and/or RFs, with a predefined composite endpoint (preeclampsia or large-for-gestational-age infant or shoulder dystocia). RESULTS: Included were 4518 women: 23.5% had HIP and 71.1% had at least one RF. The distribution among our four groups was: HIP-/RF- (n=1144); HIP-/RF+ (n=2313); HIP+/RF- (n=163); and HIP+/RF+ (n=898). HIP was more frequent when RFs were present rather than absent (33.1% vs 15.4%, respectively; P<0.001). Incidence of the composite endpoint differed significantly (P<0.0001) across groups [HIP-/RF- 6.3%; HIP-/RF+ 13.2%; HIP+/RF- 8.6%; and HIP+/RF+ 17.1% (HIP effect: P<0.05; RF effect: P<0.001; interaction HIP * RF: P=0.94)] and significantly increased with the number of RFs (no RF: 6.3%, 1 RF: 10.8%, 2 RFs: 14.7%, 3 RFs: 28.0%, 4-5 RFs: 25.0%; P<0.0001). CONCLUSION: RFs are predictive of HIP, although 15.4% of women with HIP have no RFs. Also, irrespective of HIP status, RFs are predictive of HIP-related events, suggesting that overweight/obesity, the only modifiable RFs, could be targets of interventions to improve pregnancy prognosis.

Early screening for gestational diabetes mellitus is not associated with improved pregnancy outcomes: an observational study including 9795 women.

AIMS: In addition to screening for hyperglycaemia during pregnancy after 24 weeks of gestation (WG), the current guidelines also suggest screening in early pregnancy and referring women with early gestational diabetes mellitus (eGDM) or overt diabetes (OD) for immediate care. Our aim was to evaluate this strategy. METHODS: This study evaluated, at our hospital (2012-2016), whether the incidence of a predefined composite outcome (preeclampsia, large-for-gestational-age infant, shoulder dystocia) and secondary outcomes was different when women were screened only after 22WG ('late screening only') or before 22WG and treated for eGDM or OD if present, with repeat screening after 22WG if absent ('early ± late screening'). RESULTS: Early ± late screening (n = 4605, 47.0%) increased between 2012 and 2016 (P < 0.0001) and was associated with more risk factors for GDM than late screening only. Glycaemic status differed in both groups (early ± late screening: eGDM 10.3%, GDM 12.1%, OD 0.9% vs. late screening only: GDM 16.8%, OD 1.2%; P < 0.001), with a higher rate of insulin therapy (8.9% vs. 6.0%; P < 0.001) and less gestational weight gain (11.1 ± 5.4 kg vs. 11.4 ± 5.5 kg; P = 0.013) in the early ± late screening group. Rates of those meeting the composite criterion were similar in both groups [11.6% vs. 12.0%, respectively; odds ratio (OR): 1.040, 95% confidence interval (CI): 0.920-1.176; P = 0.53] and remained comparable after adjusting for Propensity Scores (OR: 1.046, 95% CI: 0.924-1.185; P = 0.4790). Rates for secondary outcomes were also similar in both groups. CONCLUSION: While a strategy including early measurement of fasting plasma glucose during pregnancy increases the incidence and care of hyperglycaemia during pregnancy, it may not significantly improve pregnancy outcomes.

Are Obese Individuals with no Feature of Metabolic Syndrome but Increased Waist Circumference Really Healthy? A Cross Sectional Study.

AIM: Patients displaying the metabolically healthy but obese phenotype have an intermediate cardiometabolic prognosis compared to normal weight healthy and metabolically unhealthy obese subjects. We aimed to evaluate the proportion of patients with a definite metabolically healthy obese phenotype and better characterize them. METHODS: Definite metabolically healthy obese phenotype was defined as having none of the International Diabetes Federation metabolic syndrome criteria, excluding waist circumference. We recruited 1 159 obese patients (body mass index 38.4±6.3 kg/m(2)) including 943 women, without known diabetes. Patients were characterized for cardiometabolic disorders. RESULTS: As the 202 (17.4%) metabolically healthy obese individuals were younger and had lower body mass indexes than the 957 metabolically unhealthy obese patients, they were matched for gender, age and body mass index with 404 metabolically unhealthy obese patients. In addition to the features of metabolic syndrome, when compared to unhealthy subjects, definite metabolically healthy obese patients were less frequently found with either homeostasis model assessment of insulin resistance index>3 (23.6 vs. 38.9%, p<0.001), or abnormal oral glucose tolerance test (13.9 vs. 33.9%, p<0.001), or HbA1c value≥5.7% (43.9 vs. 54.2%, p<0.05) or pulse pressure≥60 mmHg (11.7 vs. 64.9%, p<0.001). However, there were no significant differences in the prevalence of microalbuminuria (11.1 vs. 12.3%), cardiac autonomic dysfunction (45.5 vs. 35.3%) and fatty liver index ≥ 60 (5.6 vs. 10.2%). CONCLUSION: Our data do not support the characterization of metabolically healthy obesity, even definite, as really healthy, as many patients with this phenotype have abnormal cardiovascular markers and glucose or liver abnormalities. HbA1c measurement seems to be more sensitive than OGTT to detect dysglycemia in this population.

Fetal gender is not associated with either gestational diabetes mellitus or placental weight: A cohort study.

AIM: This study assessed whether male fetal gender increases the risk of maternal gestational diabetes mellitus (GDM) and investigated the association with placental weight. METHODS: The study included 20,149 women without pregestational diabetes who delivered singletons at our hospital between January 2002 and December 2010. There was universal screening for GDM, and all placentas were weighed at delivery. RESULTS: GDM (affecting 14.2% of women) was not associated with fetal gender (male fetuses in women without and with GDM: 51.8% vs. 51.7%, respectively; P=0.957), and remained likewise after logistic-regression analysis of risk factors for GDM (OR: 1.007, 95% CI: 0.930-1.091; P=0.858). Placental weights were 600±126g, 596±123g, 584±118g and 587±181g in women with GDM/female, GDM/male, no GDM/female and no GDM/male fetuses, respectively (GDM effect: P=0.017; gender effect: P=0.41; GDM * gender effect: P=0.16). CONCLUSION: The present results suggest that fetal gender is not associated with GDM and, while placental weights were higher in cases of GDM, there were still no gender effects.

Pregnancy adverse outcomes related to pregravid body mass index and gestational weight gain, according to the presence or not of gestational diabetes mellitus: A retrospective observational study.

AIM: This study retrospectively evaluated the complications associated with prepregnancy overweight (OW) or obesity (OB) and gestational weight gain (GWG) in women with or without universally screened and treated gestational diabetes mellitus (GDM). METHODS: A total of 15,551 non-Asian women without pregravid diabetes or hypertension who delivered singleton babies (2002-2010) were classified according to GDM (13.5%), pregestational body mass index (BMI; normal range: 18.5-24.9kg/m(2)), OW (26.2%), OB (13.9%; BMI≥30kg/m(2)) and GWG (<7kg: 32%; 7-11.5kg: 37%; 11.6-16kg: 23%;>16kg: 8%). Main outcome measures were large/small for gestational age (LGA/SGA), caesarean section, preeclampsia, preterm delivery and shoulder dystocia. RESULTS: GDM was associated with more LGA babies [Odds Ratio (OR): 2.12, 95% confidence interval (CI): 1.85-2.43], caesarean section (OR: 1.49, 95% CI: 1.34-1.65) and preeclampsia (OR: 1.59, 95% CI: 1.21-2.09). OW/OB and GWG were associated with LGA infants whatever the GDM status, and with SGA babies only in women without GDM. LGA status was independently associated with GWG in women with GDM (11.6-16kg: OR: 1.74, 95% CI: 1.49-2.03 and>16kg OR: 3.42, 95% CI: 2.83-4.13 vs 7-11.5kg) and in women without GDM (OR: 2.14, 95% CI: 1.54-2.97 or OR: 2.65, 95% CI: 1.68-4.17, respectively), and with BMI only in women without GDM (OR: 1.12, 95% CI: 1.00-1.24, per 10kg/m(2)). SGA status was independently associated with OW (OR: 0.86, 95% CI: 0.77-0.98), OB (OR: 0.84, 95% CI: 0.72-0.98) and GWG<7kg (1.14, 95% CI: 1.01-1.29) only in women without GDM. CONCLUSION: In our European cohort and considering the triumvirate of GDM, BMI and GWG, GDM was the main contributor to caesarean section and preeclampsia. OW/OB and GWG contributed to LGA and SGA infants mainly in women without GDM.

Haemoglobin glycation may partly explain the discordance between HbA1c measurement and oral glucose tolerance test to diagnose dysglycaemia in overweight/obese subjects.

AIM: This study assessed whether the poor correlation between HbA1c and oral glucose tolerance test (OGTT) for dysglycaemia diagnosis may be explained by haemoglobin glycation (HbG). METHODS: A total of 1033 consecutive overweight or obese patients with no known diabetes underwent OGTT and measurement of HbA1c to diagnose diabetes and dysglycaemia (American Diabetes Association criteria). For each OGTT result category, low, medium and high HbG was defined according to the mean HbA1c/fructosamine ratio and mean fructosamine. High HbG was defined as values greater than mean values in each OGTT category for both HbA1c/fructosamine ratio and fructosamine levels, and low HbG was defined as lower values of both. The remaining patients were considered medium HbG. RESULTS: Based on OGTT and HbA1c values, 267 (25.8%) and 443 (42.8%) patients had intermediate hyperglycaemia, and 66 (6.4%) and 95 (9.2%) patients had diabetes, respectively. The results were discordant for intermediate hyperglycaemia or diabetes diagnosis in 41.7% and for diabetes diagnosis in 10.0% of the patients. The proportion of patients with HbA1c≥6.5%, but without OGTT-diagnosed diabetes, was 0%, 3.8% and 32.8% in the low-HbG, medium-HbG and high-HbG groups, respectively. In contrast, the proportion of patients with HbA1c<5.7%, but with an abnormal OGTT, was 30.4%, 11.1% and 0%, respectively. The AUROC of HbA1c to detect OGTT-diagnosed diabetes was better in the medium-HbG group [0.874 (0.816-0.931)] than in those with low or high HbG [0.628 (0.489-0.768); P<0.01]. Only age was independently associated with high-HbG status [10-year OR: 1.3 (1.1-1.5); P<0.0001]. CONCLUSION: Haemoglobin glycation may explain many of the discordant results between HbA1c and OGTT when used for dysglycaemia diagnosis.