Bariatric-metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial.

BACKGROUND: Observational studies suggest that bariatric-metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial. METHODS: We did a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. We included participants aged 25-70 years with obesity (BMI 30-55 kg/m2), with or without type 2 diabetes, with histologically confirmed NASH. We randomly assigned (1:1:1) participants to lifestyle modification plus best medical care, Roux-en-Y gastric bypass, or sleeve gastrectomy. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at 1-year follow-up. This study is registered at ClinicalTrials.gov, NCT03524365. FINDINGS: Between April 15, 2019, and June 21, 2021, we biopsy screened 431 participants; of these, 103 (24%) did not have histological NASH and 40 (9%) declined to participate. We randomly assigned 288 (67%) participants with biopsy-proven NASH to lifestyle modification plus best medical care (n=96 [33%]), Roux-en-Y gastric bypass (n=96 [33%]), or sleeve gastrectomy (n=96 [33%]). In the intention-to-treat analysis, the percentage of participants who met the primary endpoint was significantly higher in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; p<0·0001). The calculated probability of NASH resolution was 3·60 times greater (95% CI 2·19-5·92; p<0·0001) in the Roux-en-Y gastric bypass group and 3·67 times greater (2·23-6·02; p<0·0001) in the sleeve gastrectomy group compared with in the lifestyle modification group. In the per protocol analysis (236 [82%] participants who completed the trial), the primary endpoint was met in 54 (70%) of 77 participants in the Roux-en-Y gastric bypass group and 55 (70%) of 79 participants in the sleeve gastrectomy group, compared with 15 (19%) of 80 in the lifestyle modification group (p<0·0001). No deaths or life-threatening complications were reported in this study. Severe adverse events occurred in ten (6%) participants who had bariatric-metabolic surgery, but these participants did not require re-operations and severe adverse events were resolved with medical or endoscopic management. INTERPRETATION: Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH. FUNDING: Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy.

Single Institution Experience in the Management of Locally Advanced (pT4) Differentiated Thyroid Carcinomas.

BACKGROUND: Locally infiltrating (T4) differentiated thyroid carcinomas (DTC) represent a challenge. Surgical strategy and adjuvant therapy should be planned balancing morbidity and oncologic outcome. A series of patients with T4 DTC who underwent multidisciplinary evaluation and treatment is reported. The main study endpoints were the oncologic outcome, complication rates, and risk factors for tumor recurrence. PATIENTS AND METHODS: All DTC cases operated between 2009 and 2021 were reviewed and T4 DTC cases were identified. En bloc resection of inferior laryngeal nerve (ILN), tracheal, and/or internal jugular vein (IJV) was performed in cases of massive infiltration. In cases of pharyngoesophageal junction (PEJ) invasion, the shaving technique was always applied. RESULTS: Among 4775 DTC cases, 60 were T4. ILN infiltration was documented in 45 cases (en bloc resection in 9), tracheal infiltration in 14 (tracheal resection in 2), PEJ invasion in 11 (R0 resection in 7 cases and < 1 cm residual tissue in 4 cases), IJV resection in 6, and laryngeal in 2. In total, 11 postoperative ILN palsy, 23 transient hypoparathyroidisms, and 2 hematomas requiring reoperation were registered. Final histology showed 7 pN0, 22 pN1a, and 31 pN1b tumors. Aggressive variants were observed in 47 patients. All but 1 patient underwent radioiodine treatment, 12 underwent adjuvant external beam radiation therapy (EBRT), and 2 underwent chemotherapy. At a median follow-up of 58 months, no tumor-related death was registered, and seven patients required reoperation for recurrence. Tracheal invasion was the only significant factor negatively impacting recurrence (p = 0.045). CONCLUSIONS: A multidisciplinary approach is essential for the management of T4 DTC. Individualized and balanced surgical strategy and adjuvant treatments, in particular EBRT, ensure control of locally advanced disease with acceptable morbidity.

Robot-assisted vs laparoscopic lateral transabdominal adrenalectomy: a propensity score matching analysis.

BACKGROUND: Laparoscopic adrenalectomy (LA) is the gold standard treatment for adrenal lesions. Robot-assisted adrenalectomy (RAA) is a safe approach, associated with higher costs in absence of clear-cut benefits. Several series reported some advantages of RAA over LA in challenging cases, but definitive conclusions are lacking. We evaluated the cost effectiveness and outcomes of robotic (R-LTA) and laparoscopic (L-LTA) approach for lateral transabdominal adrenalectomy in a high-volume center. METHODS: Among 356 minimally invasive adrenalectomies (January 2012-August 2021), 286 were performed with a lateral transabdominal approach: 191 L-LTA and 95 R-LTA. The R-LTA and L-LTA patients were matched for lesion side and size, hormone secretion, and BMI with propensity score matching (PSM) analysis. Postoperative complications, operative time (OT), postoperative stay (POS), and costs were compared. RESULTS: PSM analysis identified 184 patients, 92 in R-LTA and 92 in L-LTA group. The two groups were well matched. The median lesion size was 4 cm in both groups (p = 0.533). Hormonal hypersecretion was detected in 55 and 54 patients of R-LTA and L-LTA group, respectively (p = 1). Median OT was significantly longer in R-LTA group (90.0 vs 65.0 min) (p < 0.001). No conversion was registered. Median POS was similar (4.0 vs 3.0 days in the R-LTA and L-LTA) (p = 0.467). No difference in postoperative complications was found (p = 1). The cost margin analysis showed a positive income for both procedures (3137 vs 3968 € for R-LTA and L-LTA). In the multiple logistic regression analysis, independent risk factors for postoperative complications were hypercortisolism (OR = 3.926, p = 0.049) and OT > 75 min (OR = 8.177, p = 0.048). CONCLUSIONS: The postoperative outcomes of R-LTA and L-TLA were similar in our experience. Despite the higher cost, RAA appears to be cost effective and economically sustainable in a high-volume center (60 adrenalectomies/year), especially if performed in challenging cases, including patients with large (> 6 cm) and/or functioning tumors.

Single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S): experience from a high-bariatric volume center.

PURPOSE: Biliopancreatic diversion with duodenal switch and single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) are technically demanding hypo-absorptive bariatric procedures generally indicated in super-obese patients (BMI ≥ 50 kg/m2). Data from the literature prove the procedure to be safe and effective, with promising bariatric and metabolic effects. Anyway, international societies support the creation of multicentric national and international registries to obtain more homogeneous data over the long period. We aimed to report our experience with this procedure. METHODS: Among 2313 patients who underwent bariatric procedures at our institution, between July 2016 and August 2021, 121 (5.2%) consenting patients were scheduled for SADI-S as primary (SADIS) or revisional procedure after sleeve gastrectomy (SADI) (respectively 87 and 34 patients). Early and late post-operative complications, operative time, post-operative stay, and follow-up data were analyzed. RESULTS: Overall, the median preoperative BMI was 52.3 (48.75-57.05) kg/m2 with a median age of 44 (39-51) years, the median operative time was 120 (100-155) min. Complications at 30th-day post-op were registered in 4 (3.3%) patients and late complications in 4 (3.3%) patients. At a median follow-up of 31 (14-39) months, the median percentage excess weight loss was 79.8 (55.15-91.45)%, and the median total weight loss was 57.0650 (43.3925-71.3475)%. CONCLUSION: Our data, coherently with the literature, confirm that SADI-S is a safe, effective procedure with acceptable complications rate. Larger studies with longer follow-ups are necessary to draw definitive conclusions.

Video-Assisted Thyroidectomy for Papillary Thyroid Carcinoma: Oncologic Outcome in Patients with Follow-Up ≥ 10 Years.

BACKGROUND: Video-assisted thyroidectomy (VAT) arisen as a valid treatment for selected patients with papillary thyroid carcinoma (PTC), but no data concerning long-term oncologic outcome are available. The primary aim of the study was to evaluate the oncologic outcome of patients who underwent VAT for PTC with a follow-up ≥ 10 years. METHODS: The medical charts of all the patients who successfully underwent VAT for PTC were reviewed. The patients with a minimum follow-up period of 120-months were included. Patients with unifocal PTC ≤ 1 cm, in the absence of lymph node metastases, without gross extracapsular invasion and age < 45 years were considered "low-risk" patients and followed with ultrasound and serum thyroglobulin (sTg) on levothyroxine (LT4); the remaining patients underwent nuclear medicine evaluation. RESULTS: Two hundred and fifty-seven patients, operated on between May 2000 and October 2006, were included. Postoperative complications included four transient recurrent palsies, 76 transient and 1 permanent hypocalcemia. One hundred and four low-risk patients were followed with ultrasound and sTg on LT4. At a mean follow-up of 136.6 months, mean sTg on LT4 was 0.1 ± 0.1 ng/ml. None of them showed recurrence. The remaining 153 patients underwent nuclear medicine evaluation. Among these 153, 62 did not undergo radioiodine ablation (RAI). At a mean follow-up of 150.8 months, mean sTg on LT4 was 0.1 ± 0.1 ng/ml. None of them showed recurrence. The remaining 91 patients underwent RAI. Mean pre-RAI sTg off-LT4 was 8.3 ± 5.8 ng/ml, mean radioiodine uptake was 2.8 ± 4.4%. Among these 91, three pN1a patients developed a lateral neck node recurrence. No other recurrence was registered. At the latest follow-up mean sTg on LT4 in this subgroup of patients was 0.1 ± 0.2 ng/ml. CONCLUSIONS: The long-term (≥ 10 years) oncologic outcome further demonstrates that VAT is a valid option for selected PTC patients.

Risk Factors for Central Neck Lymph Node Metastases in Micro- Versus Macro- Clinically Node Negative Papillary Thyroid Carcinoma.

BACKGROUND: Tumor size has been advocated as possible risk factors for occult central lymph node metastases (CNM) in papillary thyroid carcinoma (PTC) patients. This prospective study evaluated factors that could identify patients at higher risk of occult CNM, especially comparing micro-PTC and macro-PTC. METHODS: One hundred and eighty-six patients were recruited. All the patients had cN0 clinically unifocal PTC and underwent total thyroidectomy and bilateral prophylactic central neck dissection. Risk factors for occult CNM in micro- and macro-PTC patients were evaluated. RESULTS: Eighty-two patients showed CNM. The rate of CNM did not differ among different sizes cut off (≤20 mm, ≤10 mm, ≤5 mm P = NS). Significantly more pN1a than pN0 patients had pT3 tumors (35/82 vs. 26/104) (P < 0.05), extracapsular invasion (35/82 vs. 22/104) (P < 0.01) and microscopic multifocal disease (50/82 vs. 47/104) (P < 0.05). Independent risk factors for CNM were extracapsular invasion and multifocality at multivariate analysis. Risk factors for CNM in 77 micro-PTC were extracapsular invasion (16/31 pN1 vs. 10/46 pN0, P < 0.05) and multifocality (21/31 pN1 vs. 16/46 pN0, P < 0.01). Among 109 macro-PTC, risk factors for CNM were angioinvasion (15/51 pN1 vs. 7/58 pN0, P < 0.05) and classic PTC at the final histology (PTC vs. tall cell variant vs. follicular variant PTC) (P < 0.05). CONCLUSIONS: Risk factors for CNM can differ between micro- and macro-PTC, but no preoperatively known clinical parameter is predictor of CNM in cN0 clinically unifocal PTC.

Ipsilateral Central Neck Dissection Plus Frozen Section Examination Versus Prophylactic Bilateral Central Neck Dissection in cN0 Papillary Thyroid Carcinoma.

BACKGROUND: Ipsilateral central compartment node dissection (IpsiCCD) can reduce the morbidity of prophylactic bilateral central compartment node dissection (BilCCD) in papillary thyroid carcinoma (PTC) but it carries the risk of contralateral metastases being overlooked. Frozen section examination (FSE) of removed ipsilateral nodes has been proposed to intraoperatively assess nodal status. We compared IpsiCCD plus FSE and BilCCD in clinically unifocal and node negative PTC. METHODS: One hundred patients were prospectively assigned to undergo total thyroidectomy (TT) plus BilCCD or TT plus IpsiCCD. In the IpsiCCD group, removed lymph nodes were sent for FSE. If FSE was positive for metastases, a BilCCD was accomplished. RESULTS: The two groups included 50 patients each. Overall, occult lymph node metastases were found in 41 patients-20 in the IpsiCCD group and 21 in the BilCCD group. FSE correctly identified occult node metastases in 13 of 20 pN1a patients in the IpsiCCD group (overall accuracy 86 %). Seven node metastases were not detected at FSE-five were micrometastases (≤2 mm). Six of 13 patients in the IpsiCCD group who underwent BilCCD and 6 of 21 BilCCD pN1a patients had bilateral metastases. More patients in the BilCCD group showed transient hypocalcemia (27/50 vs. 18/50, respectively) [p = NS]. No patient experienced recurrent disease. CONCLUSIONS: FSE of ipsilateral nodes is accurate in determining nodal status, allowing the extension of the central neck clearance to be reliably modulated. Routine IpsiCCD plus FSE of the ipsilateral nodes could be a valid alternative to prophylactic BilCCD since it allows accurate staging and may reduce morbidity.

Morbidity of central neck dissection: primary surgery vs reoperation. Results of a case-control study.

PURPOSE: Complication rate in reoperative central neck node surgery is one of the main arguments to favor prophylactic central neck dissection at first operation in patients with papillary thyroid carcinoma. We evaluated if reoperative central neck dissection implies an increased postoperative morbidity. Secondarily, we aimed also to verify the effectiveness of the surgical resection of reoperative central neck dissection. METHODS: Forty-one patients who underwent reoperative central neck dissection after initial thyroidectomy for papillary thyroid carcinoma between January 2008 and May 2012 were compared to 41 controls who underwent central neck dissection at initial operation. RESULTS: The two groups were well matched for age, sex, and pN stage (P = 0.296, 0.199, and 1.000, respectively). Three patients had distant metastases at presentation. No significant difference was found concerning mean number of removed nodes (P = 0.064). No significant difference was found between the reoperative and the control groups concerning transient hypocalcemia (17 vs 19, respectively) (P = 0.901) and transient recurrent nerve palsy (2 vs 2) (P = 0.608). Follow-up was completed in 69 out of all the included patients (85.2 %). At a mean follow-up of 33 months, two patients (2.9 %) experienced nodal recurrence. CONCLUSIONS: Morbidity of central neck dissection is similar for primary surgery and reoperation. In high-volume centers, reoperative central neck dissection can be safely accomplished when needed, allowing to achieve locoregional control in most of patients.

Actual incidence and clinical behaviour of follicular thyroid carcinoma: an institutional experience.

Follicular thyroid carcinoma classically accounts for 10-32% of thyroid malignancies. We determined the incidence and the behaviour of follicular thyroid carcinoma in an endemic goitre area. A comparative analysis between minimally invasive and widely invasive follicular thyroid carcinoma was performed. The medical records of all patients who underwent thyroidectomy from October 1998 to April 2012 for thyroid malignancies were reviewed. Those who had a histological diagnosis of follicular carcinoma were included. Among 5203 patients, 130 (2.5%) were included. Distant metastases at presentation were observed in four patients. Sixty-six patients had a minimally invasive follicular carcinoma and 64 a widely invasive follicular carcinoma. In 63 patients an oxyphilic variant was registered. Minimally/widely invasive ratio was 41/26 for usual follicular carcinoma and 25/38 for oxyphilic variant (P < 0.05). Patients with widely invasive tumors had larger tumors (P < 0.001) and more frequently oxyphilic variant (P < 0.05) than those with minimally invasive tumours. No significant difference was found between widely invasive and minimally invasive tumors and between usual follicular carcinoma and oxyphilic variant regarding the recurrence rate (P = NS). The incidence of follicular thyroid carcinoma is much lower than classically retained. Aggressive treatment, including total thyroidectomy and radioiodine ablation, should be proposed to all patients.

Impact of COVID-19 pandemic on thyroidectomy for malignant diseases in high-volume referral centers.

INTRODUCTION: The COVID-19 pandemic has limited the availability of healthcare resources for non-COVID patients and decreased elective surgeries, including thyroidectomy. Despite the prioritization of surgical procedures, it has been reported that thyroidectomy for thyroid cancer (TCa) was adversely impacted. We assessed the impact of the pandemic on the surgical activities of two high-volume referral centers. MATERIALS AND METHODS: Patients operated at two National Referral Centers for Thyroid Surgery between 03/01/2020 and 02/28/2021 (COVID-19 period) were included (P-Group). The cohort was compared with patients operated at the same Centers between 03/01/2019 and 02/29/2020 (pre-COVID-19 pandemic) (C-Group). RESULTS: Overall, 7017 patients were included: 2782 in the P-Group and 4235 in the C-Group. The absolute number of patients with TCa was not significantly different between the two groups, while the rate of malignant disease was significantly higher in the P-Group (1103/2782 vs 1190/4235) (P < 0.0001). Significantly more patients in the P-Group had central (237/1103 vs 232/1190) and lateral (167/1103 vs 140/1190) neck node metastases (P = 0.001). Overall, the complications rate was significantly lower (11.9% vs 15.1%) and hospital stay was significantly shorter (1.7 ± 1.5 vs 1.9 ± 2.2 days) in the P-Group (P < 0.05). CONCLUSION: The COVID-19 pandemic significantly decreased the overall number of thyroidectomies but did not affect the number of operations for TCa. Optimization of management protocols, due to limited resource availability for non-COVID patients, positively impacted the complication rate and hospital stay.

Upcoming Italian clinical practice guidelines on endoscopic bariatric treatment of overweight and obesity: design and methodological aspects.

Obesity/overweight and its complications are a growing problem in many countries. Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to develop the first Italian guidelines for the endoscopic bariatric treatment of obesity. The creation of SICOB Guidelines is based on an extended work made by a panel of 44 members and a coordinator. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology has been used to decide the aims, reference population, and target health professionals. Clinical questions have been created using the PICO (patient, intervention, comparison, outcome) conceptual framework. We will perform systematic reviews, formal meta-analyses, and network meta-analyses for each PICO and critical outcomes aimed at assessing and rating the efficacy and safety of endoscopic bariatric procedures in comparison with either no interventions, lifestyle interventions, or approved anti-obesity treatments in trials with a follow-up of at least 52 weeks. For PICO on temporary endoscopic bariatric treatments, we will also consider RCT with a minimum duration of 6 months. The panel proposed 8 questions, organized into four domains: A. Indication for endoscopic bariatric surgery; B. Revisional surgery; C. Temporary gastric and duodenal-jejunal procedures; D. Endoscopic diagnosis/treatment of bariatric and metabolic surgery complications. These guidelines will apply to patients aged ≥ 14 years) with body mass index (BMI) ≥ 27 kg/m2 and requiring endoscopic bariatric surgery or endoscopic diagnostic and/or therapeutic procedures. The areas covered by the clinical questions included indications of endoscopic bariatric surgery, types of surgery, revisional surgery, and management of bariatric and metabolic surgery complications.

SICOB Italian clinical practice guidelines for the surgical treatment of obesity and associated diseases using GRADE methodology on bariatric and metabolic surgery.

Obesity is a chronic disease associated with increased morbidity and mortality and reduced quality of life. Pharmacotherapy can be associated with life style changes in increasing and maintaining weight loss and ameliorating obesity-related complications and comorbidities. In patients affected by obesity and uncontrolled obesity-associated complications or high degrees of BMI (> 40 Kg/m2), metabolic bariatric surgery can be a valid therapeutic option. Many different types of surgical procedures have been developed in last decades, mainly performed via laparoscopic approaches. However, clinical indications for metabolic and bariatric surgery (MBS) and the choice of the most appropriate type of procedure have not been clarified so far.The Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to design and develop the updated version of the Italian guidelines aimed at assisting healthcare professionals in the choice of the surgical option for the treatment of obesity and related conditions. Between June and October 2022, a panel of 24 experts and an evidence review team (ERT, 10 members), participated in the definition of clinical questions, outcomes, and recommendations and collected and analyzed all the available evidence on the basis of pre-specified search strategies. GRADE methodology and PICO (Patient, Intervention, Comparison, Outcome) conceptual framework have been adopted for the development of the present guidelines. Aim of the present guideline is to verify indications to surgery with respect to the presence of comorbid conditions, evaluate the different types of surgical approaches and endoscopic bariatric procedure and revise indication to revision surgery and postoperative procedures.

Can intraoperative frozen section influence the extension of central neck dissection in cN0 papillary thyroid carcinoma?

PURPOSE: Ipsilateral central compartment node dissection has been proposed to reduce the morbidity of prophylactic bilateral central compartment node dissection in papillary thyroid carcinoma (PTC), but it carries the risk of contralateral metastases being overlooked in approximately 25 % of patients. We aimed to verify if frozen section examination (FSE) can identify patients who could benefit from bilateral central compartment node dissection. METHODS: All the consenting patients with clinically unifocal PTC, without any preoperative evidence of lymph node involvement, observed between September 2010 and September 2011 underwent total thyroidectomy plus bilateral central compartment node dissection. Ipsilateral central compartment nodes were sent for FSE. RESULTS: Forty-eight patients were included. Mean number of removed nodes was 13.2 ± 6.8. Final histology showed lymph node metastases in 21 patients: ipsilateral in 15, bilateral in 6. FSE accurately predicted lymph node status in 43 patients (27 node negative, 16 node positive). Five node metastases were not detected at FSE: three were micrometastases (≤ 2 mm). Sensitivity, specificity and overall accuracy of FSE in definition of N status status were 80.7, 100, and 90 %, respectively. CONCLUSIONS: FSE is accurate in predicting node metastases in clinically unifocal node negative PTC and can be useful in determining the extension of central compartment node dissection. False-negative results are reported mainly in case of micrometastases, which usually have limited clinical implications.

Robotic vs laparoscopic approach for single anastomosis duodenal-ileal bypass with sleeve gastrectomy: a propensity score matching analysis.

Biliopancreatic diversion with duodenal switch and single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) are technically demanding hypo-absorptive bariatric procedures. They are often indicated in superobese patients (BMI ≥ 50 kg/m2), as robotic platform could improve ergonomics against a thick abdominal wall, preventing bending of instruments and simplifying hand-sewn anastomoses. We aimed to report our experience with robotic SADI-S (R-group) and to compare outcomes with the laparoscopic (L-group) approach. Among 2143 patients who underwent bariatric procedures at our institution between July 2016 and June 2021, 116 (5.4%) consenting patients were scheduled for SADI-S as primary or revisional procedure: 94 L-group, 22 R-group. R-group and L-group patients were matched using PSM analysis to overcome patients selection bias. Postoperative complications, operative time (OT), post-operative stay (POS) and follow-up data were compared. After PSM, 44 patients (22 patients for each group) were compared (Chi-square 0.317, p = 0.985). Median age, gender, median BMI, preoperative rates of comorbidities, previous abdominal bariatric and non-bariatric surgeries and type of surgical procedures (SADI-S/SADI) were comparable. Median OT was shorter in the L-group (130 Vs 191 min, p < 0.001). 30-days' re-operative complications and late complications rates were comparable. At 25-months' mean follow-up, the median Percentage Excess Weight Loss (72%) was comparable between the groups (p = 0.989). L-group and R-group were comparable in terms of re-operative complication rate and short-term outcomes. The robotic platform may increase the rate of single step procedure in challenging cases. Larger studies with longer follow-up and cost-analysis are necessary to draw definitive conclusions.

Medium-Term Nutritional and Metabolic Outcome of Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S).

INTRODUCTION: Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy (SADI-S), like other hypoabsorptive procedures, could be burdened by long-term nutritional deficiencies such as malnutrition, anemia, hypocalcemia, and hyperparathyroidism. OBJECTIVES: We aimed to report our experience in terms of mid-term (2 years) bariatric, nutritional, and metabolic results in patients who underwent SADI-S both as a primary or revisional procedure. METHODS: One hundred twenty-one patients were scheduled for SADI-S as a primary or revisional procedure from July 2016 to February 2020 and completed at least 2 years of follow-up. Demographic features, bariatric, nutritional, and metabolic results were analyzed during a stepped follow-up at 3 months, 6 months, 1 year and 2 years. RESULTS: Sixty-six patients (47 female and 19 male) were included. The median preoperative BMI was 53 (48-58) kg/m2. Comorbidities were reported in 48 (72.7%) patients. At 2 years, patients had a median BMI of 27 (27-31) kg/m2 (p < 0.001) with a median %EWL of 85.3% (72.1-96.1), a TWL of 75 (49-100) kg, and a %TWL of 50.9% (40.7-56.9). The complete remission rate was 87.5% for type 2 diabetes mellitus, 83.3% for obstructive sleep apnea syndrome and 64.5% for hypertension. The main nutritional deficiencies post SADI-S were vitamin D (31.82%) and folic acid deficiencies (9.09%). CONCLUSION: SADI-S could be considered as an efficient and safe procedure with regard to nutritional status, at least in mid-term (2 years) results. It represents a promising bariatric procedure because of the excellent metabolic and bariatric outcomes with acceptable nutritional deficiency rates. Nevertheless, larger studies with longer follow-ups are necessary to draw definitive conclusions.

Risk factors for postoperative cervical haematoma in patients undergoing thyroidectomy: a retrospective, multicenter, international analysis (REDHOT study).

Background: Postoperative cervical haematoma represents an infrequent but potentially life-threatening complication of thyroidectomy. Since this complication is uncommon, the assessment of risk factors associated with its development is challenging. The main aim of this study was to identify the risk factors for its occurrence. Methods: Patients undergoing thyroidectomy in seven high-volume thyroid surgery centers in Europe, between January 2020 and December 2022, were retrospectively analysed. Based on the onset of cervical haematoma, two groups were identified: Cervical Haematoma (CH) Group and No Cervical Haematoma (NoCH) Group. Univariate analysis was performed to compare these two groups. Moreover, employing multivariate analysis, all potential independent risk factors for the development of this complication were assessed. Results: Eight thousand eight hundred and thirty-nine patients were enrolled: 8,561 were included in NoCH Group and 278 in CH Group. Surgical revision of haemostasis was performed in 70 (25.18%) patients. The overall incidence of postoperative cervical haematoma was 3.15% (0.79% for cervical haematomas requiring surgical revision of haemostasis, and 2.35% for those managed conservatively). The timing of onset of cervical haematomas requiring surgical revision of haemostasis was within six hours after the end of the operation in 52 (74.28%) patients. Readmission was necessary in 3 (1.08%) cases. At multivariate analysis, male sex (P < 0.001), older age (P < 0.001), higher BMI (P = 0.021), unilateral lateral neck dissection (P < 0.001), drain placement (P = 0.007), and shorter operative times (P < 0.001) were found to be independent risk factors for cervical haematoma. Conclusions: Based on our findings, we believe that patients with the identified risk factors should be closely monitored in the postoperative period, particularly during the first six hours after the operation, and excluded from outpatient surgery.

Video-assisted versus conventional total thyroidectomy and central compartment neck dissection for papillary thyroid carcinoma.

BACKGROUND: Although video-assisted (VA) thyroidectomy emerged as effective treatment for selected patients with papillary thyroid carcinoma (PTC), some concerns remain about obtaining adequate central neck node clearance. We compared patients who underwent VA and conventional total thyroidectomy (TT) and central compartment dissection (CCD) for PTC. METHODS: A total of 52 consecutive patients successfully underwent VA-TT and VA-CCD for PTC (VA group) were compared to 52 controls who underwent conventional TT and CCD (C group) for PTC. RESULTS: The two groups were matched for age (p = 0.75), sex (p = 0.07), and tumor size (p = 1.0). Operating time (p = 0.23), overall postoperative complications (p = 0.41), pT (p = 0.44), and pN (p = 0.84) were similar in the two groups. The mean number of removed nodes was similar (10.6 ± 4.6 in VA group vs. 12.2 ± 5.6 in C group) (p = 0.11).Mean postoperative serum thyroglobulin (sTg) off levothyroxine (LT4) suppressive treatment was 3.2 ± 5.0 ng/ ml in the VA group and 2.6 ± 7.4 ng/ml in the C-group (P = 0.67). Mean postoperative radioiodine uptake (RAIU) was similar in the two groups (1.5 ± 1.3 vs. 1.7 ± 1.3%) (p = 0.49). When pN1a patients alone were considered, no difference was found between the VA group (21 patients) and the controls (24 patients) concerning the mean number of removed nodes (10.3 ± 4.1 vs. 12.4 ± 5.6) (p = 0.16), the mean sTg off LT4 (4.4 ± 6.0 vs. 1.9 ± 2.7 ng/ml) (p = 0.07) and the mean RAIU (1.9 ± 1.5 vs. 1.7% ± 1.3%) (p = 0.63). CONCLUSIONS: The results of VA-TT and CCD in selected cases of PTC appear to be comparable to those of conventional surgery. A longer follow-up and larger series are necessary to draw definitive conclusions concerning longterm outcomes.

Post-thyroidectomy hypocalcemia: Is a routine preferable over a selective supplementation?

BACKGROUND: Comparative studies among protocols for the management of post-total thyroidectomy (TT) hypocalcemia are lacking. We compared the effectiveness of PTH-driven selective supplementation (PD-SS) and routine calcium and calcitriol supplementation with preoperative calcitriol administration in preventing symptomatic hypocalcemia (SH) and readmission. METHODS: Three-hundred consecutive patients undergoing TT were assigned to 3 groups: the PD-SS group, the high-dose routine supplementation (HD-RS) group and the low-dose routine supplementation (LD-RS) group. RESULTS: Mean post-operative stay was shorter in HD-RS patients when compared to PD-SS and LD-RS (p < 0.001). Significantly more patients in the PD-SS group experienced SH (p = 0.042). The rate of post-operative hypocalcemia was not significantly different among the groups (p = 0.063). No readmission for SH or hypercalcemia occurred. CONCLUSIONS: HD-RS emerged as the most effective treatment to prevent SH, without increasing the risk of readmission for calcitriol-related hypercalcemia. Basing on the present results, HD-RS should be recommended as the preferable protocol.

Prevalence and predictors of non-alcoholic steatohepatitis in subjects with morbid obesity and with or without type 2 diabetes.

AIM: To investigate the prevalence of biopsy-proven non-alcoholic steatohepatitis (NASH) in a cohort of patients with morbid obesity and with or without type 2 diabetes (T2D) and to find non-invasive predictors of NASH severity. METHODS: We evaluated a cohort of 412 subjects (age 19-67 years, body mass index-BMI: 44.98 kg/m2), who underwent fine-needle liver biopsy during bariatric surgery. Thirty-six percent of the subjects were affected by T2D. Liver biopsies were classified according to the Kleiner's NAFLD Activity Score (NAS). NAFLD Fibrosis Score (NFS), AST/ALT ratio, AST to Platelet ratio (APRI), fibrosis-4 score (FIB4) were calculated. A neural network analysis (NNA) was run to predict NASH severity. RESULTS: The prevalence of biopsy-proven NASH was 63% and 78% in subjects with obesity and without or with T2D, respectively. T2D doubled the risk of NASH [OR 2.079 (95% IC=1.31-3.29)]. The prevalence of NAFL increased with the increase of BMI, while there was an inverse correlation between BMI and NASH (r=-0.145 p=0.003). Only mild liver fibrosis was observed. HOMA-IR was positively associated with hepatocyte ballooning (r=0.208, p<0.0001) and fibrosis (r=0.159, p=0.008). The NNA highlighted a specificity of 77.3% using HDL-cholesterol, BMI, and HOMA-IR as main determinants of NASH. CONCLUSIONS: Our data show a higher prevalence of NASH in patients with morbid obesity than reported in the literature and the pivotal role of T2D among the risk factors for NASH development. However, the inverse correlation observed between BMI and biopsy-proven NASH suggests that over a certain threshold adiposity can be somewhat protective against liver damage. Our model predicts NASH presence with high specificity, thus helping identifying subjects who should promptly undergo liver biopsy.