Robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese).

BACKGROUND: Nearly 65% of patients with endometrial cancer who undergo primary hysterectomy have concurrent obesity. Retrospective data show advantages in using robotic surgery in these patients compared with conventional laparoscopy, namely lower conversion rate, increased rate of same-day discharge, and reduced blood loss. Nevertheless, to date no prospective randomized controlled trials have compared laparoscopic surgery versus robotic-assisted surgery in morbidly obese patients. PRIMARY OBJECTIVE: The robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese) trial aims to find the most appropriate minimally invasive surgical approach in morbidly obese patients with endometrial carcinoma. STUDY HYPOTHESIS: Robotic surgery will reduce conversions to laparotomy in endometrial cancer patients with obesity compared with those who undergo surgery with conventional laparoscopy. TRIAL DESIGN: This phase III multi-institutional study will randomize consecutive obese women with apparent early-stage endometrial cancer to either laparoscopic or robot-assisted surgery. MAJOR INCLUSION/EXCLUSION RITERIA: The RObese trial will include obese (BMI≥30 kg/m2) patients aged over 18 years with apparent 2009 Federation of Gynecology and Obstetrics (FIGO) stage IA-IB endometriod endometrial cancer. PRIMARY ENDPOINT: Conversion rate to laparotomy between laparoscopic surgery versus robot-assisted surgery. SAMPLE SIZE: RObese is a superiority trial. The clinical superiority margin for this study is defined as a difference in conversion rate of -6%. Assuming a significance level of 0.05 and a power of 80%, the study plans to randomize 566 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Patient recruitment will be completed by 2026, and follow-up will be completed by 2029 with presentation of data shortly thereafter. Two interim analyses are planned: one after the first 188 and the second after 376 randomized patients. TRIAL REGISTRATION: NCT05974995.

Effects of guidelines on adeno-tonsillar surgery on the clinical behaviour of otorhinolaryngologists in Italy.

BACKGROUND: Several guidelines on adeno-tonsillar disease have been proposed in recent years and some discrepancies in relation both to clinical manifestations and indications for surgical treatment have emerged. The aim of the study was to verify what influence (adeno)-tonsillectomy guidelines have had on the clinical behaviour of ENT specialists in Italy. Our study is a retrospective and multi-centre case series with chart review. METHODS: The survey involved 14,770 children, aged between the ages of 2 and 11, who had undergone adeno-tonsillar surgery between 2002 and 2008 in fourteen Italian tertiary and secondary referral centres. Anova test was used for the statistical analysis, assuming p < 0.05 as the minimum statistical significance value. RESULTS: The frequency of adeno-tonsillar surgeries did not change significantly (p>0.05) during the study period and following the Italian policy document publication. Overall, adeno-tonsillectomy was the most frequent intervention (64.1%), followed by adenoidectomy (31.1%) and tonsillectomy (4.8%). The indications for surgery did not change significantly for each of the operations (p>0.05), with the exception of adeno-tonsillectomy in case of feverish episodes due to acute recurrent tonsillitis ≥ 5 without nasal obstruction (decreased p= 0.010) , even when the feverish episodes due to acute recurrent tonsillitis were < 5 over the last year. Nasal obstruction was associated with feverish episodes due to acute recurrent tonsillitis in 65.2% of operated cases, while otitis media had been diagnosed in 43.3% of the patients studied. CONCLUSIONS: The recommendations first developed in Italy in a 2003 policy document and then resumed in guidelines in 2008, were not implemented by ENT units involved in the survey. The study highlights the fact that the indications for adeno-tonsillar operations are based on the overall clinical presentation (comorbidity) rather than on a single symptom. Guidelines are necessary to give coherent recommendations based on both the findings obtained through randomized controlled trials and the data collected from observational studies.

Outpatient Hysteroscopic Polypectomy-A Retrospective Study Comparing Rigid and Semirigid Office Hysteroscopes.

Endometrial polyps are one of the most common pathological conditions in gynecology. Hysteroscopy is the gold standard for the diagnosis and treatment of endometrial polyps. The purpose of this multicenter, retrospective study was to compare patients' pain perception during an operative hysteroscopic endometrial polypectomy in an outpatient setting with two different hysteroscopes (rigid and semirigid) and to identify some clinical and intraoperative characteristics that are related to worsening pain during the procedure. We included women that underwent, at the same time as an diagnostic hysteroscopy, the complete removal of an endometrial polyp (using the see-and-treat strategy) without any kind of analgesia. A total of 166 patients were enrolled, of which 102 patients underwent a polypectomy with a semirigid hysteroscope and 64 patients underwent the procedure with a rigid hysteroscope. No differences were found during the diagnostic step; on the contrary, after the operative procedure, a statistically significant greater degree of pain was reported when the semirigid hysteroscope was used. Cervical stenosis and menopausal status were risk factors for pain both in the diagnostic step and in the operative one. Our results confirm that operative hysteroscopic endometrial polypectomy in an outpatient setting is an effective, safe, and well-tolerated procedure and indicate that it might be better tolerated if a rigid rather than semirigid instrument is used.

Comparison of Different Near-Infrared Technologies to Detect Sentinel Lymph Node in Uterine Cancer: A Prospective Comparative Cohort Study.

OBJECTIVES: Sentinel lymph node biopsy is considered a crucial step in endometrial cancer staging. Cervical injection has become the most favored technique and indocyanine green has been demonstrated to be more accurate than other tracers. Different near-infrared camera systems are currently being used to detect indocyanine green in sentinel lymph nodes and have been compared in different patients. The present study aimed to determine the number and site of sentinel lymph nodes detected in the same patients with two different near-infrared technologies. METHODS: This is a prospective, single-center, observational, non-sponsored study. Patients with presumed uterine-confined endometrial cancer were prospectively enrolled. After cervical injection, two different near-infrared cameras were used to detect sentinel lymph nodes at the same time: Olympus, Tokyo, Japan-considered the standard (SNIR); and Medtronic, Minneapolis, MN, USA with VISION SENSE® which is a new laser near-infrared (LNIR) fluorescence laparoscope. The two cameras were alternatively switched on to detect sentinel lymph nodes in the same patients. RESULTS: Seventy-four consecutive patients were included in the study. Most of the patients were diagnosed with endometrioid histology (62, 83.8%), FIGO stage IA (48, 64.9%), grade 2 (43, 58.1%), and underwent surgery with laparoscopic approach (70, 94.0%). The bilateral detection rate was 56/74 (75.7%) with SNIR and 63/74 (85.1%) with LNIR (p = 0.214). The total number of sentinel lymph nodes identified in the left hemipelvis was 65 and 70 with SNIR and LNIR, respectively; while in the right hemipelvis, there were 74 and 76, respectively. The median number of sentinel lymph nodes identified with SNIR and LNIR was 2 (range, 0-4) and 2 (range, 0-4), respectively (p = 0.370). No difference in site of sentinel lymph node detection was evident between the two technologies (p = 0.994). Twelve patients (16.2%) had sentinel lymph node metastasis: in all cases metastatic sentinel lymph nodes were detected both with Olympus and LNIR. CONCLUSIONS: No difference in bilateral detection rate and number or site of sentinel lymph node detection was evident comparing two different technologies of near-infrared camera for ICG detection in endometrial cancer patients. No difference in sentinel lymph node metastases identification was detected between the two technologies.

Oral bacteriotherapy in children with recurrent respiratory infections: a real-life study.

Children with recurrent respiratory infections (RRI) represent a social issue for the economic burden and the familiar negative impact. Bacteriotherapy, such as the administration of "good" bacteria, is a new therapeutic strategy that could be potentially effective in preventing infections. The current study tested the hypothesis of preventing RRI by oral Bacteriotherapy in a real-life setting. This open study was conducted in an outpatient clinic, enrolling 51 children (27 males, mean age 4.8 ± 2.6 years) suffering from RRI. Children were treated with an oral spray, containing Streptococcus salivarius 24SMB and Streptococcus oralis89a (125 x 109 CFU/g), 2 puffs per os once/day for 30 consecutive days; this course was repeated for 3 months. The evaluated parameters were: RI number and school absences reported in the current year; these outcomes were compared with those recorded in the past year. The mean number of RI significantly diminished: from 5.17 (2.30) in the past year to 2.25 (2.43) after the treatment (p<0.0001). The mean number of school absences significantly diminished (from 3.35 to 1.86; p<0.0001). In conclusion, this real-life study suggests that oral Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis89a could efficaciously and safely prevent RRI in children.

Blunt dissection versus electronic molecular resonance bipolar dissection for tonsillectomy: operative time and intraoperative and postoperative bleeding and pain.

OBJECTIVE: To compare operative time, intraoperative and postoperative bleeding and pain using two different techniques for tonsillectomy: electronic molecular resonance bipolar tonsillectomy and blunt dissection tonsillectomy. METHODS: From January 2005 to December 2006, a prospective, randomised study was performed in 800 children, aged from 3 to 10 years, admitted to the ENT (Ear Nose Throat) Unit of Giannina Gaslini Institute, Genoa, Italy to undergo tonsillectomy. Patients were randomised into two surgical groups, Group A (electronic molecular resonance tonsillectomy, EMRBT) and Group B (blunt dissection tonsillectomy). Operative time, intraoperative blood loss and postoperative complications were recorded. During 10 days after surgery, children and their parents were also asked to provide a rating of the patients' current pain intensity using a visual analogue scale. In this period, the parents were also asked to note the analgesic drugs administered. RESULTS: Duration of surgery and blood loss were significantly much lower in the group undergoing electronic molecular resonance bipolar tonsillectomy (p<0.0001). Postoperative pain scores resulted significantly different between the two methods on days 5 (p=0.05) and 8 (p=0.001) in evaluations by mothers. Moreover, in evaluations by patients pain scores resulted significantly different between the two methods on days 3 (p=0.02), 8 (p=0.005) and 9 (p=0.01). We found no difference between boys and girls in pain scores in the 10 days considered, nor between children older than 5 yrs and children younger than or aged 5 years. No statistically significant differences between the two techniques were found in the use of analgesics in all postoperative evaluations. CONCLUSIONS: This study showed that the use of electronic molecular resonance bipolar tonsillectomy, compared to blunt dissection, has several advantages. Reduced operative time and intraoperative bleeding make EMRBT more cost effective and allow an increased number of operations. Concerning postoperative pain, the two techniques did not present significant differences in the use of analgesics. The number of postoperative bleeding episodes was also similar in the two groups of patients.

Bacteriotherapy for preventing recurrent upper respiratory infections in children: a real-world experience.

Background Recurrent upper respiratory infections (RURI) constitute a social problem for both their pharmaco-economic impact and the burden for the family. Bacteriotherapy could be an interesting preventive option. Objective The aim of this study was to evaluate the preventive effects of RURI in children. Design The study was designed as spontaneous, and was conducted in real-life seting. Globally, 80 children (40 males, mean age 5.26 (2.52) years) with RURI were enrolled. Children were treated with Streptococcus salivarius 24SMB and Streptococcus oralis 89a: nasal spray 2 puffs per nostril twice/day for a week for 3 monthly courses. Number of URI, and school and work absences were evaluated and compared with the past year. Results Bacteriotherapy significantly halved the mean number of URI episodes being 5.98 (2.30) in the past year and 2.75 (2.43) after the treatment (p<0.0001). Bacteriotherapy also induced an over 35% reduction both in the number of school days and in the number of working days missed per month from 4.50 (2.81) to 2.80 (3.42) and from 2.33 (2.36) to 1.48 (2.16) respectively (p<0.0001). Conclusions This and real-life study provides the first evidence that Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray could be effective in preventing RURI in children.

MB11 BERAphone and auditory brainstem response in newborns at audiologic risk: comparison of results.

OBJECTIVE: To compare the diagnostic effectiveness of Automated Auditory Brainstem Responses (MB11 technique) with that of standard Auditory Brainstem Responses (ABR) in a sample of newborns evaluated after the second month of life. METHODS: From October 2002 to February 2005, audiologic evaluations were performed in full-term newborns who presented altered otoacoustic emissions and in newborns considered at audiologic risk admitted to the ENT (Ear Nose Throat) Unit of Giannina Gaslini Institute, Genoa, Italy. Our sample included 201 children (104 males and 97 females) who underwent on the same day an audiologic test using MB11 BERAphone Maico and standard ABR test. RESULTS: Out of the 388 ears examined, 378 (97.4%) showed agreement between the two techniques, whereas in 10 (2.6%) there was no agreement. Interobserver agreement was excellent (kappa=0.92+/-0.02 S.E., p=0.0001). The MB11 test yielded no false negatives and 10 false positives which resulted normal at ABR. The MB11 test showed very good specificity 96.8% (95% CI 94.8-98.7%) and sensitivity 100% (95% CI 93.9-100%), positive predictive value 88.2% (95% CI 79-93.9%) and negative predictive value 100% (95% CI 98.4-100%) for diagnosis of hearing loss. CONCLUSIONS: The results obtained confirm the absolute validity of MB11 screening test in subjects at audiologic risk. Furthermore, the test can be used to esclude normal hearing subjects (threshold 40 dB HL) and to refer hearing loss subjects to subsequent ABR for diagnosis.

Management of nontuberculous mycobacterial lymphadenitis in a tertiary care children's hospital: A 20year experience.

PURPOSE: Nontuberculous mycobacteria are uncommon cause of chronic cervicofacial lymphadenitis in healthy children. We describe clinical features and management strategies of cervicofacial nontuberculous mycobacterium lymphadenitis in a tertiary pediatric hospital. METHODS: Retrospective analysis of medical records of children discharged from 1992 to 2014 with a diagnosis of cervicofacial nontuberculous mycobacterium was made. Diagnosis certainty was based on microhistological investigations. Clinical stage was evaluated according to lymph node size and presence of fistulas. Successful therapy was defined by the regression of the lymph node enlargement (>75%) or complete surgical excision without relapse. RESULTS: Cervicofacial nontuberculous mycobacterium was diagnosed in 33 patients. Complete excision was performed in 73% of cases primarily observed in our hospital, while 83% of those referred from other hospitals required further surgical treatment. No case of relapse was observed after one year of follow-up. CONCLUSIONS: We recommend surgical approach as the first therapeutic option in the management of cervicofacial nontuberculous mycobacterium lymphadenitis. LEVELS OF EVIDENCE: Prognosis and Retrospective Study - Level II.

Corticosteroids may favor proliferation of thoracic inflammatory myofibroblastic tumors.

Inflammatory myofibroblastic tumor (IMT) was thought to represent a benign post-infectious or post-inflammatory process cured by surgical resection. However, reports of cases with an aggressive clinical course suggest the need for caution about the prognosis. The treatment of choice is a complete surgical resection, while medical treatment options are limited. Corticosteroid therapy has been used with some success in unresectable lesion. However, rapid progression of lung IMT after prednisone treatment has been reported, raising the hypothesis that corticosteroids may favor a tumultuous proliferation of this lesion, possibly through immunosuppression. We here report a similar observation and suggest that other mechanisms may be involved. A 5-year and 6-month-old boy presented with a 72 hr history of breathlessness, initially responsive to albuterol and prednisone. He represented 15 days later with increasing symptoms despite further prednisone treatment. CT chest scan showed a mass lesion in the tracheal lumen, which on biopsy was found to be an IMT. The possibility that prednisone may have an enhancing effect on IMT cell proliferation is demonstrated through IMT cell culture and discussed.

Gaslini's tracheal team: preliminary experience after one year of paediatric airway reconstructive surgery.

BACKGROUND: Congenital and acquired airway anomalies represent a relatively common albeit challenging problem in a national tertiary care hospital. In the past, most of these patients were sent to foreign Centres because of the lack of local experience in reconstructive surgery of the paediatric airway. In 2009, a dedicated team was established at our Institute. Gaslini's Tracheal Team includes different professionals, namely anaesthetists, intensive care specialists, neonatologists, pulmonologists, radiologists, and ENT, paediatric, and cardiovascular surgeons. The aim of this project was to provide these multidisciplinary patients, at any time, with intensive care, radiological investigations, diagnostic and operative endoscopy, reconstructive surgery, ECMO or cardiopulmonary bypass. Aim of this study is to present the results of the first year of airway reconstructive surgery activity of the Tracheal Team. METHODS: Between September 2009 and December 2010, 97 patients were evaluated or treated by our Gaslini Tracheal Team. Most of them were evaluated by both rigid and flexible endoscopy. In this study we included 8 patients who underwent reconstructive surgery of the airways. Four of them were referred to our centre or previously treated surgically or endoscopically without success in other Centres. RESULTS: Eight patients required 9 surgical procedures on the airway: 4 cricotracheal resections, 2 laryngotracheoplasties, 1 tracheal resection, 1 repair of laryngeal cleft and 1 foreign body removal with cardiopulmonary bypass through anterior tracheal opening. Moreover, in 1 case secondary aortopexy was performed. All patients achieved finally good results, but two of them required two surgeries and most required endoscopic manoeuvres after surgery. The most complex cases were the ones who had already been previously treated. CONCLUSIONS: The treatment of paediatric airway anomalies requires a dedicated multidisciplinary approach and a single tertiary care Centre providing rapid access to endoscopic and surgical manoeuvres on upper and lower airways and the possibility to start immediately cardiopulmonary bypass or ECMO.The preliminary experience of the Tracheal Team shows that good results can be obtained with this multidisciplinary approach in the treatment of complicated cases. The centralization of all the cases in one or few national Centres should be considered.

Detection of transplacental melanoma metastasis using quantitative PCR.

To choose the most appropriate treatment for children affected by a transplacental metastasis, it is crucial to ascertain the maternal origin of the tumor. Up-to-date conclusive diagnosis is generally achieved through fluorescence in situ hybridization or karyotyping analysis. Herein, we report an alternative, reliable assay for rapidly defining vertical cancer transmission to the fetus by using quantitative polymerase chain reaction. Our assay indicates that quantification of the copy number of the sex chromosomes by specific short tandem repeats markers, in genomic DNA purified from the tumor biopsy cells, could be used to correctly evaluate transplacental metastasis events.

Post-tonsillectomy late haemorrhage: is it a preferably night-time event?

AIM: To evaluate the relationship between the incidence of late post-tonsillectomy haemorrhage and its prevalence in a definite period of the day. STUDY DESIGN AND SETTING: This retrospective study was carried out in the Ear Nose Throat (ENT) Unit of Giannina Gaslini Institute, Genoa, Italy on children operated for adenotonsillectomy (AT) or tonsillectomy (T) between January 2003 and February 2008. We considered in the study all the post-tonsillectomy late haemorrhages irrespective of their severity and for each case we evaluated whether they recurred in the day-time (B) (between 9.00 a.m. and 9.00 p.m.) or in the night-time (A) (between 9.00 p.m. and 9.00 a.m.). Finally we considered the number of haemorrhages per hour in the whole day. RESULTS: Out of 3306 patients undergoing elective adenotonsillectomy or tonsillectomy, post-operative late haemorrhage occurred in 59 (1.78%). We noted that 42 episodes (71.2%) occurred in the night-time and 17 (28.8%) in the day-time. The average time from the operation was 8.4 days. A statistically significant difference (p=0.002) was found when comparing the frequencies of night-time and day-time haemorrhages. We did not observe any significant difference in the distribution per hour of the haemorrhages. CONCLUSIONS: The incidence of post-tonsillectomy late haemorrhage in our study population was 1.78%. A statistically significant difference was found between night-time and day-time haemorrhages. Even though no significant distribution of haemorrhages per hour was observed, we underline that we recorded 32 (54.2%) events in 2 periods of the day: from 10 p.m. to 1 a.m. and from 6 to 9 a.m.

CD5+ B cells with the features of subepithelial B cells found in human tonsils.

This study describes a CD5+ B cell that differs from the majority of the CD5+ B cells from human tonsils. This cell, isolated from in vivo activated B cells, expressed activation markers and featured a CD23-, IgMhigh, IgDlow surface phenotype, responded to T cell-independent type-2 antigens in vitro, and was detected in the subepithelial (SE) areas, the tonsil equivalent of the splenic marginal zone (MZ). Most of the cells utilized unmutated Ig VH genes, although cells with mutated genes also were found, a finding confirmed by single-cell studies. Mutated sequences were more frequent in suspensions enriched for CD27+ cells. Repeated VDJ gene sequences were observed in different molecular clones from the same cell suspension, suggesting in situ expansion. These CD5+ B cells seem to share features with previously characterized tonsil CD5- SE B cells and differ from the majority of tonsil CD5+ B cells, which have the surface phenotype of follicular mantle B cells, lack activation markers, do not respond to T cell-independent antigens, and utilize unmutated VH genes. These data are discussed considering the present views on the origin of B cell subset populations and the relationships between MZ and B1 cells.

Laryngeal schwannoma in an 8-year-old boy with inspiratory dyspnea.

BACKGROUND: Schwannomas of the larynx are rare lesions in the pediatric age group. METHODS: In this article, we report on the neuroimaging features of a schwannoma arising from the left aryepiglottic fold in an 8-year-old boy with a 6-month history of inspiratory dyspnea. RESULTS: Neuroimaging showed a well-defined, avoid mass originating from the left aryepiglottic fold. The lesion was removed endoscopically. CONCLUSION: Complete removal of laryngeal schwannomas is curative, and adjuvant treatment is not required.

B lymphocytes in humans express ZAP-70 when activated in vivo.

ZAP-70 is a protein tyrosine kinase initially found in T and NK cells. Recently, this important signaling element was detected in leukemic B cells from a subgroup of patients with B cell chronic lymphocytic leukemia (B-CLL). In this study, ZAP-70 was detected in normal B cells from human tonsils, but not from peripheral blood. The cDNA sequence of B cell ZAP-70 was the same as that in T cells. Germinal center B cells and plasma cells had a substantial proportion of ZAP-70+ cells, while memory and follicular mantle B cells, which contain low numbers of activated B cells, expressed relatively little ZAP-70. A cell fraction of IgD+, CD38+ B cells, which are comprised of many in vivo activated B cells, exhibited the highest levels of ZAP-70. Density gradient fractionation of tonsil B cells confirmed that ZAP-70 was not expressed by resting B cells, but was expressed by buoyant, in vivo activated B cells. In these B cells, the expression of ZAP-70 correlated with that of CD38 and not with that of CD5, a hallmark of B-CLL cells. B-CLL cells are activated cells and their ZAP-70 expression reflects a normal property of activated B cells populations rather than a neoplastic aberration.