A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life

Purpose The aim of this study is to test in a doubleblinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria. Background There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS. Methods This is a double-blinded, randomised placebocontrolled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed. Results Sixty-four IBS patients (symbiotic n032, 64 % females, mean age 38.7±12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p<0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group. Conclusions This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted

Topical administration of hyaluronic acid in children with recurrent or chronic middle ear inflammations

Hyaluronic acid (HA) treatment has been successfully performed in patients with recurrent upper airway infections or rhinitis. The aim of this study was to assess the efficacy and safety of the topical nasal administration of an HA-based compound by investigating its effects in children with recurrent or chronic middle ear inflammations and chronic adenoiditis. A prospective, single-blind, 1:1 randomised controlled study was performed to compare otoscopy, tympanometry and pure-tone audiometry in children which received the daily topical administration of normal 0.9% sodium chloride saline solution (control group) or 9 mg of sodium hyaluronate in 3 mL of a 0.9% sodium saline solution. The final analysis was based on 116 children (49.1% boys; mean age, 62.9 \ub1 17.9 months): 58 in the control group and 58 in the study group. At the end of follow-up, the prevalence of patients with impaired otoscopy was significantly lower in the study group (P value = 0.024) compared to baseline but not in the control group. In comparison with baseline, the prevalence of patients with impaired tympanometry at the end of the follow-up period was significantly lower in the study group (P value = 0.047) but not in the control group. The reduction in the prevalence of patients with conductive hearing loss (CHL) (P value = 0.008) and those with moderate CHL (P value = 0.048) was significant in the study group, but not in the control group. The mean auditory threshold had also significantly improved by the end of treatment in the study group (P value = 0.004) but not in the control group. Our findings confirm the safety of intermittent treatment with a topical nasal sodium hyaluronate solution and are the first to document its beneficial effect on clinical and audiological outcomes in children with recurrent or chronic middle ear inflammations associated with chronic adenoiditis

Optimal treatment duration of glyceryl trinitrate for chronic anal fissure: results of a prospective randomized multicenter trial

Background: Chronic anal fissure (CAF) is a painful condition that is unlikely to resolve with conventional conservative management. Previous studies have reported that topical treatment of CAF with glyceryl trinitrate (GTN) reduces pain and promotes healing, but optimal treatment duration is unknown. Methods: To assess the effect of different treatment durations on CAF, we designed a prospective randomized trial comparing 40 versus 80 days with twice daily topical 0.4% GTN treatment (Rectogesic®, Prostrakan Group). Chronicity was defined by the presence of both morphological (fibrosis, skin tag, exposed sphincter, hypertrophied anal papilla) and time criteria (symptoms present for more than 2 months or pain of less duration but similar episodes in the past). A gravity score (1 = no visible sphincter; 2 = visible sphincter; 3 = visible sphincter and fibrosis) was used at baseline. Fissure healing, the primary endpoint of the study, maximum pain at defecation measured with VAS and maximum anal resting pressure were assessed at baseline and at 14, 28, 40 and 80 days. Data was gathered at the end of the assigned treatment. Results: Of 188 patients with chronic fissure, 96 were randomized to the 40-day group and 92 to the 80-day group. Patients were well matched for sex, age, VAS and fissure score. There were 34 (19%) patients who did not complete treatment, 18 (10%) because of side effects. Of 154 patients who completed treatment, 90 (58%) had their fissures healed and 105 (68%) were pain free. There was no difference in healing or symptoms between the 40- and the 80-day group. There was no predictor of fissure healing. A low fissure gravity score correlated with increased resolution of pain (P &lt; 0.05) and improvement of VAS score (P &lt; 0.05) on both univariate and multivariate analysis. A lower baseline resting pressure was associated with better pain resolution on univariate analysis (P &lt; 0.01). VAS at defecation and fissure healing significantly improved until 40 days (P &lt; 0.001), while the difference between 40 and 80 days was not significant. Conclusion: We found no benefits in treating CAF with topical GTN for 80 days compared to 40 days. Fissure healing and VAS improvement continue until 6 weeks of treatment but are unlikely thereafter. © 2010 Springer-Verlag

Appendectomy during the COVID-19 pandemic in Italy: a multicenter ambispective cohort study by the Italian Society of Endoscopic Surgery and new technologies (the CRAC study)

Major surgical societies advised using non-operative management of appendicitis and suggested against laparoscopy during the COVID-19 pandemic. The hypothesis is that a significant reduction in the number of emergent appendectomies was observed during the pandemic, restricted to complex cases. The study aimed to analyse emergent surgical appendectomies during pandemic on a national basis and compare it to the same period of the previous year. This is a multicentre, retrospective, observational study investigating the outcomes of patients undergoing emergent appendectomy in March-April 2019 vs March-April 2020. The primary outcome was the number of appendectomies performed, classified according to the American Association for the Surgery of Trauma (AAST) score. Secondary outcomes were the type of surgical technique employed (laparoscopic vs open) and the complication rates. One thousand five hundred forty one patients with acute appendicitis underwent surgery during the two study periods. 1337 (86.8%) patients met the inclusion criteria: 546 (40.8%) patients underwent surgery for acute appendicitis in 2020 and 791 (59.2%) in 2019. According to AAST, patients with complicated appendicitis operated in 2019 were 30.3% vs 39.9% in 2020 (p = 0.001). We observed an increase in the number of post-operative complications in 2020 (15.9%) compared to 2019 (9.6%) (p &lt; 0.001). The following determinants increased the likelihood of complication occurrence: undergoing surgery during 2020 (+ 67%), the increase of a unit in the AAST score (+ 26%), surgery performed &gt; 24 h after admission (+ 58%), open surgery (+ 112%) and conversion to open surgery (+ 166%). In Italian hospitals, in March and April 2020, the number of appendectomies has drastically dropped. During the first pandemic wave, patients undergoing surgery were more frequently affected by more severe appendicitis than the previous year's timeframe and experienced a higher number of complications. Trial registration number and date: Research Registry ID 5789, May 7th, 202

Global overview of the management of acute cholecystitis during the COVID-19 pandemic (CHOLECOVID study)

Background: This study provides a global overview of the management of patients with acute cholecystitis during the initial phase of the COVID-19 pandemic. Methods: CHOLECOVID is an international, multicentre, observational comparative study of patients admitted to hospital with acute cholecystitis during the COVID-19 pandemic. Data on management were collected for a 2-month study interval coincident with the WHO declaration of the SARS-CoV-2 pandemic and compared with an equivalent pre-pandemic time interval. Mediation analysis examined the influence of SARS-COV-2 infection on 30-day mortality. Results: This study collected data on 9783 patients with acute cholecystitis admitted to 247 hospitals across the world. The pandemic was associated with reduced availability of surgical workforce and operating facilities globally, a significant shift to worse severity of disease, and increased use of conservative management. There was a reduction (both absolute and proportionate) in the number of patients undergoing cholecystectomy from 3095 patients (56.2 per cent) pre-pandemic to 1998 patients (46.2 per cent) during the pandemic but there was no difference in 30-day all-cause mortality after cholecystectomy comparing the pre-pandemic interval with the pandemic (13 patients (0.4 per cent) pre-pandemic to 13 patients (0.6 per cent) pandemic; P = 0.355). In mediation analysis, an admission with acute cholecystitis during the pandemic was associated with a non-significant increased risk of death (OR 1.29, 95 per cent c.i. 0.93 to 1.79, P = 0.121). Conclusion: CHOLECOVID provides a unique overview of the treatment of patients with cholecystitis across the globe during the first months of the SARS-CoV-2 pandemic. The study highlights the need for system resilience in retention of elective surgical activity. Cholecystectomy was associated with a low risk of mortality and deferral of treatment results in an increase in avoidable morbidity that represents the non-COVID cost of this pandemic

Multicentre international trial of laparoscopic lavage for Hinchey III acute diverticulitis (LLO Study)

Background: Laparoscopic lavage was proposed in the 1990s to treat purulent peritonitis in patients with perforated acute diverticulitis. Prospective randomized trials had mixed results. The aim of this study was to determine the success rate of laparoscopic lavage in sepsis control and to identify a group of patients that could potentially benefit from this treatment. Methods: This retrospective multicentre international study included consecutive patients from 24 centres who underwent laparoscopic lavage from 2005 to 2015. Results: A total of 404 patients were included, 231 of whom had Hinchey III acute diverticulitis. Sepsis control was achieved in 172 patients (74·5 per cent), and was associated with lower Mannheim Peritonitis Index score and ASA grade, no evidence of free perforation, absence of extensive adhesiolysis and previous episodes of diverticulitis. The operation was immediately converted to open surgery in 19 patients. Among 212 patients who underwent laparoscopic lavage, the morbidity rate was 33·0 per cent; the reoperation rate was 13·7 per cent and the 30-day mortality rate 1·9 per cent. Twenty-one patients required readmission for early complications, of whom 11 underwent further surgery and one died. Of the 172 patients discharged uneventfully after laparoscopic lavage, a recurrent episode of acute diverticulitis was registered in 46 (26·7 per cent), at a mean of 11 (range 2–108) months. Relapse was associated with younger age, female sex and previous episodes of acute diverticulitis. Conclusion: Laparoscopic lavage showed a high rate of successful sepsis control in selected patients with perforated Hinchey III acute diverticulitis affected by peritonitis, with low rates of operative mortality, reoperation and stoma formation

Ruolo della linfoadenectomia nel management del carcinoma papillifero della tiroide

l'impatto dell'interessamento linfonodale nel carcinoma papillifero della tiroide resta controverso. L'incidenza di metastasi linfonodali è elevata e la presenza di linfonodi interessati da malattia ha un impatto negativo sull'insorgenza di recidive e sulla sopravvivenza , soprattutto in pazienti anziani. La gran parte dei chirurghi tiroidei sezione i linfonodi centrali ipsi laterali se è presente una grossa adenopatia. La dissezione del compartimento laterale del collo è riservata a pazienti con nota malattia metastatic

Stability and Convergence of a Message-Loss-Tolerant Rendezvous Algorithm for Wireless Networked Robot Systems

This article considers the problem of swarm rendezvous when robots exchange local coordination messages through an unreliable wireless communication network (i.e., message-loss occurs). First, a discrete-time second-order consensus algorithm is provided to deal with the effects of unreliable channels on wireless networked robot (WNR) systems, and drive the robots to a given geometric formation. Then, necessary and sufficient conditions for the controlled WNR to converge to a desired formation, even in the presence of messages loss, are formulated and simulatively validated. The proposed conditions provide to the WNR designer a minimal topology connectivity requirement, and a relation among algorithm step-size and control gains to be fulfilled for guaranteeing swarm rendezvous

Colonic gas transit and effects of mechanical stimulation on the abdominal wall

OC3.07.5 COLONIC GAS TRANSIT AND EFFECTS OF MECHANICAL STIMULATION ON THE ABDOMINALWALL F. Tremolaterra ∗ , A. Pascariello, D. Consalvo, C. Ciacci, P. Iovino Università Federico II, Napoli Background and aim: Bloating and abdominal distension are frequently reported by patients with functional gastrointestinal disease. Recently it has been suggested that patients with bloating have impaired intestinal handling of gas loads. Aims of our work is study the colon gas handling in irritable bowel syndrome (IBS) and functional bloating (FB) patients by a specific gas challenge test and to evaluate the effects on colon gas transit and bloating symptoms of mechanical stimulation on the abdominal wall. Material and methods: Fifteen patients (12 F, range 27-64y; 11 IBS, 4 FB) and 5 healthy control (4 F, range 20-40y) were assigned, in random order, to study I: colonic gas load (5 patients and 5 healthy control) or study II: colonic gas load + electro-mechanical stimulation of abdominal wall, active and sham (5 patients active and 5 sham). Colonic gas load study was performed by a 60 min continuous gas mixture infusion (N2, CO2, O2 in venous proportion) at 24 ml/min and by its collecting, for other 30 min, via the anal balloon-catheter. The mechanical stimulation on the abdomen was performed by an electro-mechanical stimulator (Free-lax, ADM, Israel) and was applied at active group during evacuation period of the study II. Symptom perception and abdominal distension were measured by a validated questionnaire and a metric belt-tape assembly respectively. Gas retention was calculated as the difference between the volume of gas infused and the volume of gas recovered. Results: Study I: patients developed significantly more gas retention compared to healthy control (586±50ml vs 493±41ml, p=0.01). Further the patients complained a significant more abdominal perception then healthy control either to the end infusion period (60° min) or to the end gas evacuation period (90° min) (4.5±1.0 vs 2.4±0.9 e 1.1±1.0 vs 0±0, p=0.01 e p=0.04, respectively) and more abdominal distension to the end of gas evacuation period (2.4±1.1mm vs 0.2±0.4mm, respectively; p=0.004). Study II: no statistically differences was found in gas retention, perception and abdominal distension, in all study period, among patients with or without electro-mechanical stimulation. Conclusions: Our study shows an impaired transit and tolerance of colonic gas loads in IBS and FB patients not modified by mechanical stimulation of abdominal wall. # M. Functional disorders 2. IB