Repeated two cycles of ulipristal acetate treatment improve the quality of life in premenopausal women with heavy menstrual bleeding dependent on uterine myomas, without impairment of bone health.

This observational study was conducted in premenopausal women who presented themselves at the Obstetrics and Gynecology Department of the University Hospital of Cagliari (Italy), for heavy menstrual bleeding (HMB) dependent on uterine myomas. After a screening visit, 19 women without contraindications to ulipristal acetate (UPA) treatment, were included in the study that envisaged 12 months of observation in which each subject was asked to assume UPA (tablet of 5 mg, ESMYA®, one tablet a day for 3 months: first cycle) two menstrual cycles of interruption and a second ESMYA® cycle, followed by 3 months of observation (third follow-up month, visit 4). The significant decrease of myoma volume, diagnosed after the first ESMYA® cycle, persisted until the visit 4. The HMB significantly decreased during the ESMYA® treatment and persisted until visit 4. The quality of life (QoL), evaluated with the questionnaire SF-36, significantly improved during the study. The values of estradiol (E2), biochemical parameters of bone metabolism, as well as those of lumbar and hip bone mineral density, did not change during the study in comparison with basal levels. The efficacy of two repeated ESMYA® cycles to treat uterine myomas and their related symptoms improves the QoL without interfering with bone health.

Vilaprisan for treating uterine fibroids.

INTRODUCTION: The medical strategy to antagonize myoma size and related-symptoms is to reduce estrogen and progesterone activity on myomas. This can be obtained with the GnRH agonist (GnRHa) or with compounds that antagonize progesterone stimulatory activity on myomas. Selective progesterone receptor modulators (SPRMs) bind progesterone receptor (PR), leading to both agonist and antagonist effects. The result of SPRMs's action is tissue-specific and it depends on the particular affinity and strength of each SPRM. Area covered: Ulipristal acetate (UPA) is the first SPRM registered for myoma treatment. UPA reduces heavy uterine bleeding within 7 days from the onset of treatment, whereas a longer time is required with GnRHa treatment. Vilaprisan is a novel powerful SPRM. Phase I and II studies give encouraging results on the efficacy of vilaprisan at different doses. Like other SPRMs, vilaprisan induces benign changes of endometrium (PR modulator-associated endometrial changes, PAECs). These disappear as treatment is discontinued. Unlike GnRHa treatment, neither UPA nor vilaprisan induce hypoestrogenism and associated symptoms. Phase III studies are ongoing to confirm efficacy and safety of vilaprisan in long-term treatment of symptomatic fibroids. Expert opinion: It is fundamental to underline the rapidity of action (only 3 days) in the control of myoma-related bleeding.

The stimulation of the vaginal immune system with short-term administration of a vaginal gel containing fraction of Propionibacterium acnes, hyaluronic acid and polycarbophil is efficacious in vaginal infections dependent on disorders in the vaginal ecosystem.

The vaginal immune system (VIS) is the first defense against antigens recognized as foreign. Substances capable of locally activating the VIS could be a valid strategy to treat vulvo-vaginal infections (VVI), caused by changes in the vaginal ecosystem, such as bacterial vaginosis (BV), vulvo-vaginal candidiasis (CA), and mixed vaginitis (MV). Bacterial lysates, obtained by crushing bacterial cultures, exert immuno-modulatory activities. The parietal fraction from Propionibacterium acnes is a patent of Depofarma (MoglianoVeneto, Italy). The preparation that associates such fraction to hyaluronic acid and polycarbophil is a registered trademark, commercially available in Italy as vaginal gel, Immunovag®. The study aimed to evaluate whether a 5-day-treatment with Immunovag® improves the symptoms and signs of VVI, in 60 women with Gardnerella vaginalis (GV), 154 with CA, 95 with MV, diagnosed with vulvar vaginal swab (VVS), and in 283 with BV, diagnosed with the Amsel criteria. At the end of the treatment (visit 2), the symptoms and signs of VVI disappeared in a significant number of subjects (χ2p < .02 vs pre-treatment) in all VVI groups, and their intensity was significantly (p < .0002) reduced in the subjects in which they were still present. Immunovag® represents a valid treatment of VVI induced by changes in the vaginal ecosystem.

Early prediction of hypocalcemia following thyroid surgery. A prospective randomized clinical trial.

PURPOSE: The aim of this randomized-controlled trial was to validate the results of a previous prospective single-cohort observational study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy. METHODS: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were randomized into two groups. The experimental group was submitted to iPTH assay 6 h after surgery while the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the receiver-operator characteristics (ROC) curve. RESULTS: The prevalence of hypocalcemia was 14.25% in both groups. The assay of iPTH 6 h after surgery combined with the serum calcium assay 24 h after surgery yielded the highest diagnostic accuracy in predicting hypocalcemia using ROC curves, with 100% sensitivity and 100% specificity. CONCLUSIONS: According to our previous study, the combined measurement of iPTH 6 h after surgery and of serum calcium 24 h after surgery are highly predictive of early postoperative hypocalcemia. These results are important in selecting the patients eligible for early discharge and those who need calcium and vitamin D supplementation.

Syncope with Surprise: An Unexpected Finding of Huge Gastric Diverticulum.

A gastric diverticulum is a pouch protruding from the gastric wall. The vague long clinical history ranging between dyspepsia, postprandial fullness, and upper gastrointestinal bleeding makes this condition a diagnostic challenge. We present a case of large gastric diverticulum that has been diagnosed during clinical investigations for suspected cardiovascular issues in a patient admitted at the medical ward for syncope. A 51-year-old man presented to the medical department due to a syncopal episode occurring while he was resting on the beach after having his lunch, with concomitant vague epimesogastric gravative pain without any other symptom. A diagnosis of neuromediated syncopal episode was made by the cardiologist. Due to the referred epimesogastric pain, an abdominal ultrasound scan was carried out, showing perisplenic fluid. A CT scan of the abdomen was performed to exclude splenic lesions. The CT scan revealed a large diverticulum protruding from the gastric fundus. The upper gastrointestinal endoscopy visualized a large diverticular neck situated in the posterior wall of the gastric fundus, partially filled by undigested food. The patient underwent surgery, with an uneventful postoperative course. Histologic examination showed a full-thickness stomach specimen, indicative of a congenital diverticulum. At the 2nd month of follow-up, the patient was asymptomatic.

Systematic review with meta-analysis of studies comparing single-incision laparoscopic colectomy and multiport laparoscopic colectomy.

BACKGROUND: There is currently a paucity of research comparing the clinical outcomes of single-incision laparoscopic colectomy (SILC) with those obtained with multiport laparoscopic colectomy (MLC). This meta-analysis aimed to examine whether SILC shows real benefits over MLC, especially in terms of feasibility, safety, and oncological adequacy. METHODS: A literature review of studies comparing SILC and MLC has been performed which looked at the following outcomes: mortality, morbidity, and oncological parameters of adequacy, as well as other potential benefits and drawbacks. Standardized mean difference for continuous variables and odds ratios for qualitative variables were calculated. RESULTS: Thirty studies comparing SILC and MLC were reviewed: two prospective randomized clinical trials (RCTs), eight prospective studies, and 20 retrospective comparative observational studies. Overall, in a cohort of 3502 patients who underwent surgery, SILC was used in 1068 cases (30.5 %) and MLC was used in 2434 cases (69.5 %). Mean intraoperative blood loss was significantly lower when the SILC procedure had been used (75.06 vs. 91.45 ml, P = 0.03); bowel function recovered significantly earlier in the SILC patients (1.96 vs. 2.15 days, P = 0.03); mean postoperative hospital stay was significantly shorter in the SILC group (5.55 vs. 6.60 days, P = 0.0005); and length of skin incision was significantly shorter in SILC patients (3.98 vs. 5.28 cm, P = 0.01). However, in the latter four outcomes, evidence of heterogeneity was found. In contrast, MLC showed significantly better results when compared to SILC in terms of distal free margins (12.26 vs. 10.98 cm, P = 0.01). CONCLUSIONS: SILC could be considered as a safe and feasible alternative to MLC in experienced hands. Further evidence for this surgical procedure should be assessed in the form of high-quality RCTs, with additional focus on its use in low rectal cancer resection.

Follicular thyroid carcinoma: differences in clinical relevance between minimally invasive and widely invasive tumors.

BACKGROUND: Evidence on the biological behavior and clinical courses of minimally invasive and widely invasive follicular thyroid carcinoma (MI-FTC, WI-FTC) is still debatable. The current study was conducted to identify differences between MI and WI tumors and those prognostic parameters influencing late outcome such as local recurrence and survival. METHODS: From January 1998 to October 2013, 71 patients were operated on in our department because of a FTC. A retrospective cohort study was carried out to compare 42 MI-FTC and 29 WI-FTC. The comparison involved evaluation of patient characteristics, tumor characteristics, tumor staging, and risk assessment. RESULTS: A diameter greater than 4.0 cm, the presence of vascular invasion, the TNM stage III-IVA, and the high risk at AMES system risk stratification were independent factors significantly related to the presence of a WI-FTC. The only independent predictor of recurrence and disease-free survival at 10-year follow-up was a tumor size greater than 4.0 cm. CONCLUSIONS: More attention must be paid in the postoperative tumor re-staging of those patients with tumor size larger than 4.0 cm, which was the only parameter predicting recurrence and influencing disease-free survival. Nevertheless, definitive recommendations cannot be made without a longer follow-up.

Nodal metastasis and recurrence in papillary thyroid microcarcinoma.

Despite the majority of papillary thyroid microcarcinoma (PTMC) patients has benign clinical courses, some PTMCs have a clinical presentation similar to conventional papillary thyroid carcinoma (PTC). The aim of this study was to identify risk factors for lymph node metastasis at presentation and prognostic parameters influencing nodal recurrence in PTMC. From January 1998 to October 2013, 556 consecutive patients had a diagnosis of differentiated thyroid carcinoma in our surgical department. A total of 219 (39.4 %) patients who had a pathological diagnosis of PTMC represented the cohort for the current study. We carried out a retrospective cohort study to compare 24 PTMC patients with lymph node metastasis at diagnosis (N1) and 195 PTMC patients without lymph node involvement (N0). The comparison between groups involved evaluation of patients and tumor characteristics. A diameter >8 mm, the presence of multifocality, and extrathyroid invasion (T3) were independent risk factors for nodal involvement at presentation. The presence of T3 was the only independent prognostic parameter influencing nodal recurrence. Prognostic factors for N1 at presentation and for recurrence are pathological parameters, thus it is not possible before surgery to detect PTMC patients who are at risk. However, we believe that a full treatment protocol should be also indicated in the case of PTMC according to risk stratification and cancer stage as for the conventional counterpart of PTC.

Meta-analysis of studies comparing single-incision laparoscopic appendectomy and conventional multiport laparoscopic appendectomy.

BACKGROUND: There is no consensus that single-incision laparoscopic appendectomy (SILS-A) is on a par with conventional multiport laparoscopic appendectomy (CMLA). The aim of this meta-analysis was to assess feasibility, safety, and potential benefits of SILS-A when compared with CMLA. METHODS: A literature search for studies comparing SILS-A and CMLA was performed. Studies were reviewed for the outcome of interest: patient characteristics, operative outcome, postoperative recovery, postoperative morbidity, patient satisfaction, and cosmetic results. RESULTS: Thirteen studies comparing SILS-A and CMLA were reviewed: two prospective randomized trials, four prospective studies, and seven retrospective studies. Overall, 893 patients were operated on: by SILS-A in 402 cases (45.0%) versus 491 cases (55.0%) by CMLA. Patients in the SILS-A group were significantly younger than those in the CMLA group (31.2 versus 33.5 y). No other differences were found. Patient satisfaction score was impossible to meta-analyze. CONCLUSIONS: Appendectomy via SILS-A may be considered as an alternative to CMLA. However, these results must be approached with caution as they are based on data from nonrandomized observational studies. The feasibility and safety of SILS-A must be mainly assessed for difficult clinical situations such as severe obesity, localized abscess, or diffuse peritonitis from a ruptured appendix in the setting of new prospective randomized trials.

Early prediction of hypocalcemia following total thyroidectomy using combined intact parathyroid hormone and serum calcium measurement.

BACKGROUNDS: Concomitant intact parathyroid hormone (iPTH) and serum calcium measurement is deemed to be useful in predicting hypocalcemia after total thyroidectomy. This study aimed to prospectively assess the diagnostic accuracy of combined iPTH and serum calcium measurement in predicting early postoperative hypocalcemia. METHODS: From January 2010 to January 2011, 112 patients underwent total thyroidectomy in our department. A prospective study was carried out to search for factors predicting postoperative hypocalcemia. Serum calcium, phosphorus, and iPTH levels have been measured before operation and at 6, 24, and 48 h postoperatively. Hypocalcemia was defined as a serum calcium level less than 8.0 mg/dL. Sensitivity and specificity of different serum measurements have been calculated using the receiver-operator characteristics curve. RESULTS: Thirty-three patients (29.5 %) had transient postoperative hypocalcemia. Serum iPTH level showed the highest sensitivity and specificity in predicting hypocalcemia after 6 h (84.8 % and 93.7 %, respectively) for a criterion value ≤ 12.1 pg/mL. Serum calcium level showed the highest sensitivity and specificity after 24 h (93.9 and 100.0 %, respectively) for a criterion value ≤ 7.97 mg/dL. Combined cutoffs of 6-h iPTH and 24-h serum calcium showed sensitivity and specificity of 100.0 %. CONCLUSIONS: The combined measurement of 6-h iPTH and 24-h serum calcium are highly predictive of early postoperative hypocalcemia. Patients with serum iPTH and calcium level ≤ criterion value are at major risk for developing hypocalcemia. These results are important in selecting patients eligible for early discharge and those patients who need calcium and vitamin D supplementation.