The management of low trans-sphincteric anal fistula during the COVID-19 pandemic: revisiting the role of the seton.

The management of trans-sphincteric anal fistula (TAF) includes several surgical options; however, during the COVID-19 pandemic, the access to the operating rooms was severely limited, leaving only the choice of minimally invasive procedures. This study aimed to evaluate the safety and effectiveness of the slow cutting seton technique for TAF performed in an outpatient setting during the COVID-19 pandemic.Patients treated for TAF between January 2020 and July 2022 and followed-up for at least 12 months were retrospectively evaluated. A vascular silicone tie used as seton was positioned in the fistula tract using a Lockhart-Mummery fistula probe. The seton was maintained in moderate tension until the sphincter muscle was passed. Percentage and time for healing, recurrence, SF-36, VAS and Vaizey's Score were recorded.Fifty-eight patients [36 male/22 female, median age 56.5 years (IQR 41.25-65.75) [with TAF were included. After a median time of 4 months, complete healing occurred in 53 cases (91.5%), the anal pain VAS decreased from 6 to 0, the anal incontinence scores did not change significantly and the QoL improved significantly in all the SF36 domains. No complications were recorded, but the fistula recurred in five cases (8.5%). Two of them had additional seton treatment, and three underwent other surgical procedures after the COVID-19 emergency.The slow cutting seton technique is a safe and effective treatment for outpatient procedure with minimal patient discomfort. This treatment option in healthcare delivery for TAF should be reconsidered, even outside the limited in-hospital access during the COVID-19 pandemic.

Safety and efficacy of Levorag emulgel in the treatment of anal fissures using a validated scoring system.

Introduction: Anal fissure is one of the most common anal disease characterized by intense anal pain, and deterioration of patients quality of life. Treatment is mainly based on the topical administration of calcium antagonist or nitric oxide ointments, and in cases refractory to medical treatment patients can undergo surgery. This study aims to assess the efficacy and safety of Levorag emulgel in the treatment of acute and chronic fissures using of a validated scoring system. Material and Methods: A prospective observational study was carried out on patients with anal fissures between February and May 2022. The efficacy of the treatment was evaluated using the REALISE score, a new validated scoring system that rates VAS for pain, NSAID use, pain duration, bleeding, and quality of life (QoL), recorded after 10, 20 and 30 days from the beginning of treatment. Results: Forty patients (median age 46 years, IQR 29-57, 70% women) with acute (22, 55%) or chronic (18, 45%) anal fissures entered the study. The median anal pain score according to the VAS scale decreased significantly from 7 (IQR 4.7-8) at baseline to 1 (IQR 0-3.2, p = 0.05) after 20 days. At the 30-day proctological examination, 22 patients (61%) were pain free (median VAS of 0, IQR 0-1.2, p < 0.05). Pain duration after defecation measured according to the REALISE score, showed a significant decrease after 10 days, from a median value of 2 (IQR 1-4) to 1 (IQR 1-1.2) (p < 0.005). The median value of the REALISE score decreased significantly, from 15 (IQR 11-19.25) at first proctological evaluation to 4 (IQR 4-6, p = 0.139) after 30 days of treatment. At day 30, complete fissure healing was achieved in 30 patients (80%). The healing rate was 82% and 78% in patients with acute and chronic anal fissures, respectively. Conclusion: The use of Levorag® Emulgel may represent a safe and effective non-invasive first line treatment in patients affected by acute or chronic anal fissure.

Time trend in the surgical management of obstructed defecation syndrome: a multicenter experience on behalf of the Italian Society of Colorectal Surgery (SICCR).

BACKGROUND: Surgical management of obstructed defecation syndrome (ODS) is challenging, with several surgical options showing inconsistent functional results over time. The aim of this study was to evaluate the trend in surgical management of ODS in a 10-year timeframe across Italian referral centers. METHODS: Surgeons from referral centers for the management of pelvic floor disorders and affiliated to the Italian Society of Colorectal Surgery provided data on the yearly volume of procedures for ODS from 2010 to 2019. Six common clinical scenarios of ODS were captured, including details on patient's anal sphincter function and presence of rectocele and/or rectal intussusception. Perineal repair, ventral rectopexy (VRP), transanal repair (internal Delorme), stapled transanal rectal resection (STARR), Contour Transtar, and transvaginal repair were considered in each clinical scenario. RESULTS: Twenty-five centers were included providing data on 2943 surgical patients. Procedure volumes ranged from 10-20 (54%) to 21-50 (46%) per year across centers. The most performed techniques in patients with good sphincter function were transanal repair for isolated rectocele (243/716 [34%]), transanal repair for isolated rectal intussusception (287/677 [42%]) and VRP for combined abnormalities (464/976 [48%]). When considering poor sphincter function, these were perineal repair (112/194 [57.8%]) for isolated rectocele, and VRP for the other two scenarios (60/120 [50%] and 97/260 [37%], respectively). The use of STARR and Contour Transtar decreased over time in patients with impaired sphincter function. CONCLUSIONS: The complexity of ODS treatment is confirmed by the variety of clinical scenarios that can occur and by the changing trend of surgical management over the last 10 years.

Ageing with sacral nerve modulation for fecal incontinence: how many patients get benefit after more than 10 years?

Sacral nerve modulation (SNM) has represented a major advancement in the minimally invasive management of patients with fecal incontinence (FI). Although the success rate in the short-medium term has widely been demonstrated, the very long-term outcomes are poorly investigated. This study aims to assess the effectiveness of SNM in a cohort of patients with a follow-up longer than 10 years. Clinical records of patients submitted to SNM for FI in our tertiary referral colorectal Unit between 1998 and 2010 were retrospectively reviewed looking for status of the implantable pulse generator (IPG), follow-up duration, severity of FI by the St Marks' score and quality of life. 58 patients fulfilled the entry criteria and 36 (58%, median follow-up, 12 years) accepted to take part to the telephone interview, while 22 (38%) were lost to the follow-up. Nineteen patients had their IPG removed (Group A) while 17 (27%) had the SNM still active after a median follow-up of 13 years (Group B). In the group A, the median baseline St Marks' score was 13 and did not change after the IPG removal. In group B, the median baseline St Marks' score was 14, at last IPG substitution, it was of 7 and at the last follow-up dropped to 4. In the group A, the median SF-12 physical and mental scores did not change significantly while they improved significantly in group B. A progressive deterioration of the success rate of SNM with the time has been documented after a very long-term follow-up.

Effects of topical low-dose preservative-free hydrocortisone on intraocular pressure in patients affected by ocular surface disease with and without glaucoma.

PURPOSE: This study aims to investigate the safety and efficacy of short-term treatment for ocular surface disease (OSD) with topical low-dose (1,005 mg) preservative-free hydrocortisone in one hundred patients with and without glaucoma. METHODS: This was an open label non-randomized clinical trial. Patients with OSD with and without primary open-angle glaucoma (POAG) received topical low-dose (1,005 mg) preservative-free hydrocortisone twice daily in each eye for 2 weeks. All patients underwent a complete ophthalmological examination at baseline (T0) and at 1 (T1) and 2 (T2) weeks post-treatment. At each visit, the intraocular pressure (IOP) and the ocular surface disease index (OSDI) questionnaire scores were recorded; the Schirmer test was performed only at T0 and T2. RESULTS: The OSDI score significantly decreased in both the POAG and no-POAG groups (both p < 0.0001) after hydrocortisone treatment, with no difference between the two groups (p = 0.72). There were no significant differences in IOP and Schirmer test results between T0 and T2 in both treatment groups (p = 0.68 and p = 0.83, respectively). CONCLUSIONS: Topical low-dose (1,005 mg) preservative-free hydrocortisone is safe and effective for improving OSD symptoms both in patients with and without POAG. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov under NCT04536129 on 01/09/2020 ("retrospectively registered").

Patient- and clinician-reported outcomes for the additively manufactured sub-periosteal jaw implant (AMSJI) in the maxilla: a prospective multicentre one-year follow-up study.

The clinical outcomes of maxillary rehabilitation with the additively manufactured sub-periosteal jaw implant (AMSJI; CADskills BV) were evaluated in edentulous patients with a Cawood-Howell atrophy classification ≥5 in all regions of the maxilla. Fifteen consecutive patients were included in the study and followed up for 1 year. They were interviewed using a survey protocol and were examined clinically and radiographically preoperatively (T0) and at 1 (T1), 6 (T2), and 12 (T3) months after permanent upper prosthesis placement. The patients reported an increased oral health-related quality of life. The overall mean Oral Health Impact Profile-14 score at T0 was 17.20 (standard deviation (SD) 6.42). When results at T0 were compared to those at T1 (mean 8.93, SD 5.30), a statistically significant difference was seen (P = 0.001). At T3, the mean value was 5.80 (SD 4.18). Compared to T0, there was also a statistically significant difference at T3 (P = 0.001). General satisfaction based on the numerical rating scale was a mean 49.93 at T1, which was less than patient expectation prior to treatment at T0 (52.13). A higher overall value was seen at T3 (53.20) when compared to T0. Within the constraints of the short follow-up, the AMSJI appears to be a promising tool for patients with extreme jaw atrophy. The high patient expectations were met without complications.

The REALISE score: a new statistically validated scoring system to assess the severity of anal fissures.

BACKGROUND: Anal fissure (AF) is a common, painful disease that strongly affects patients' quality of life, however, no scoring system to assess the severity of AF is available in the literature. The aim of this study was to set up and validate a reliable scoring system to quantify the severity of AF, to be used in prospective trials comparing the efficacy and the outcomes of surgical or medical treatments. METHODS: The study was conducted on patients with acute or chronic AF and a control group in a tertiary centre for coloproctology in June 2020-September 2020. Two researchers independently carried out a structured interviewer-led questionnaire at two different time points (T1/T2). The questionnaire consisted of five items selected according to the most commonly reported symptoms for AF: the item pain, was scored from 0 to 10 using a visual analogue scale, and quality of life, duration of pain, use of painkillers, and bleeding were scored from 1 to 5 using Likert-scale questions. The scoRing systEm for AnaL fIsSurE (REALISE) score was the sum of the points. Patients with AF and a control group of patients with haemorrhoids, anal fistula, or obstructed defecation syndrome entered the study. Main outcome measures were reliability, inter-/intraobserver agreement, and repeatability. RESULTS: One hundred and fifty well-matched patients (75 with AF and 75 controls) were enrolled. A significant difference was found between the mean REALISE score for patients with AF and controls (p < 0.001). The two REALISE scores were highly correlated (r = 0.99). The coefficient of repeatability was 1.45 in T1 and 1.18 in T2. CONCLUSIONS: The REALISE score may have an important role in the assessment and management of AF, in grading the severity of AF and comparing results of different treatments.

Risk factors for candidaemia in hospitalized patients with liver cirrhosis: a multicentre case-control-control study.

OBJECTIVES: The aim of this study was to evaluate the risk factors for candidaemia in patients with liver cirrhosis. METHODS: This was a case-control-control (1:2:2) study performed in four Italian tertiary centres from 2006 to 2015. Cases were patients with liver cirrhosis developing candidaemia. For every case of candidaemia we enrolled two additional patients undergoing blood cultures for suspected infection yielding isolation of a bacterial pathogen (control A) and two additional patients undergoing blood cultures for suspected infection yielding negative results (control B). Patients were matched according to age, sex and model for end stage liver disease at hospital admission. RESULTS: During the study period 90 cases, 180 controls A and 180 controls B were included. At multivariate analysis assessed by means of multinomial conditional regression models, factors independently associated with candidaemia were previous (<30 days) acute-on-chronic liver failure (relative risk ratio (RRR) 2.22 (95% confidence interval (CI) 1.09-4.54), p = 0.046), previous(<30 days) gastrointestinal endoscopy (RRR 2.38 (95% CI 1.19-4.78) p = 0.014), previous(<30 days) antibiotic treatment for at least 7 days (RRR 2.74 (95% CI 1.00-7.48), p = 0.049), presence of central venous catheter (RRR 2.77 (95% CI 1.26-6.09, p = 0.011), total parenteral nutrition (RRR 3.90 (95% CI 1.62-9.40), p = 0.002) at infection onset and length of in-hospital stay >15 days (RRR 4.63 (95% CI 2.11-10.18), p <0.001] Conversely, rifaximin treatment was associated with lower rate of candidaemia (RRR 0.38 (95% CI 0.19-0.77), p = 0.007). Multivariable analysis for 30-day mortality showed that patients with isolation of Candida spp. from blood cultures had worse outcome when compared with controls even though the difference did not reach a statistical significance (hazard ratio 1.64 (95% 0.97-2.75) p = 0.06). CONCLUSIONS: We identified previous antibiotic use, gastrointestinal endoscopy or acute-on-chronic liver failure and presence of central venous catheter especially for parenteral nutrition as independent factors associated with candidaemia. Surprisingly, chronic rifaximin use was a protective factor.

Effects of temporary sacral nerve stimulation on gastrointestinal motility and function in patients with chronic refractory slow-transit constipation.

BACKGROUND: The efficacy of sacral nerve stimulation (SNS) on patients with chronic refractory slow-transit constipation is controversial and its mechanism of action on gastrointestinal motility and transit is not fully understood. The aim of this study was to document the effects of temporary SNS on the gastrointestinal and biliary tract motility and on gastrointestinal transit in patients with refractory slow-transit constipation. METHODS: This was a prospective interventional study. Patients with slow-transit chronic constipation, unresponsive to any conservative treatment, were enrolled between January 2013 and December 2018. Patients' quality of life [patient assessment of constipation quality of life (PAC-QOL) questionnaire], constipation scores (Cleveland Clinic Constipation Score) colonic transit time (CTT), orocecal transit time (OCTT), gastric and gallbladder kinetics, together with the assessment of the autonomic nerve function were evaluated before and during temporary SNS. RESULTS: 14 patients (12 females, median age 38 years, range 24-42 years) had temporary SNS. The Cleveland Clinic Constipation Score did not change compared to baseline (23 ± 3 vs 21.4; p = 070). The PAC-QOL did not improve significantly during the stimulation period. Gallbladder/stomach motility (half-emptying time) did not change significantly before and after SNS. OCTT was delayed at baseline, as compared to standard internal normal values, and did not change during SNS. CTT did not improve significantly, although in two patients it decreased substantially from 97 to 53 h, and from 100 to 65 h. CONCLUSIONS: Temporary SNS did not have any effect on upper/lower gastrointestinal motility and transit in patients with severe constipation.

The Impact Of Covid-19 On Logistic Systems: An Italian Case Study.

since the beginning of 2020, a new virus named COVID-19 has rapidly spread to a global pandemic. The world economy has been strongly affected and early evidence suggests that its impact has involved all the sectors and business functions. In such context, logistics activities have been severely affected by the COVID-19 pandemic because of the introduction of new strict prevention rules; moreover, purchasing behaviours of customers have changed and systems had to rapidly adapt to unexpected events. This paper aims to investigate the impact of the sanitary emergency on logistics activities. A logistic provider specialized in the food and fast moving consumer goods sector has been involved in the research in order to analyse its activities and the main changes caused by the pandemic. A quantitative survey has been conducted, combining numerical data and qualitative answers. Results confirm strong effects on some sectors and an economic loss mainly due to the new procedures adopted to face the emergency.

Staff attitudes to completely smoke-free policies and smoking cessation practices in a mental health setting.

BACKGROUND: Mental health trusts in England were expected to become completely smoke-free and embed smoking cessation practices by 2018. Such policies are fraught with concerns and have received mixed support from mental health staff. Understanding staff attitudes to these practices prior to enforcement of the policy could help design an effective implementation strategy. METHODS: A cross-sectional survey was conducted with clinical and non-clinical staff in a Mental Health Trust to understand smoking cessation practices and attitudes to the implementation of a completely smoke-free policy. RESULTS: There were 631 responses. Most participants disagreed with the policy on wards (59.6%) and throughout all mental health settings (57.4%). Clinicians expressed significantly lower organizational policy support (P = 0.001) than non-clinicians (P = 0.001). Psychiatrists were more supportive of the organizational items than nurses and allied health professionals. Clinicians' attitudes towards smoking cessation practices were less positive for those who were current smokers (P < 0.001), but more positive for clinicians who had received or were interested in attending smoking cessation training (P < 0.001). CONCLUSIONS: Partial and completely smoke-free policies remain unsupported by staff in mental health settings. Smoking cessation training appears to reinforce rather than alter attitudes towards smoking cessation.

Characterisation of atmospheric pollution near an industrial site with a biogas production and combustion plant in southern Italy.

Although biogas production can have some benefits, there is a research gap on potential influence of biogas plant emissions on local air quality, thus an accurate and comprehensive evaluation of impacts of this technology is needed. This study deals with this issue by means of a characterisation of air pollution near an industrial area including a biogas production (from biomass) and combustion plant located in South Italy. The methodology consists in advanced statistical analysis on concentration of gaseous pollutants, particles concentration and size distribution in number and mass, and PM2.5 chemical composition. High-temporal resolution measurements, supported by ancillary meteorological parameters, and source apportionment of PM2.5 using Positive Matrix Factorization (PMF) receptor model, are performed. The integrated approach provides the emissive picture consisting in different anthropogenic sources (i.e. traffic, biomass burning, and industrial facilities) with particular focus on biogas plant emissions. Results showed that CO and nitrogen oxides were influenced by vehicular traffic and biomass combustion, however, a contribution of the plant to NO was observed. SO2 was influenced mainly by transport from the industrial zone, but a second local contribution compatible with the emissions of the biogas plant was detected. Number particle concentrations were analysed in four size ranges: nanoparticles (D < 0.05 µm), ultrafine particles (D < 0.3 µm), accumulation (0.3 < D < 1 µm) and coarse particles (D > 1 µm). Nanoparticles and ultrafine particles were mainly influenced by vehicular traffic and biomass burning, instead, a contribution of the plant was individuated in the accumulation mode. PMF5 identified the contribution of six sources: crustal (14.7% ± 2.1% of measured PM2.5); marine aerosol (aged) (12.9% ± 2.3%); biomass burning (32.8% ± 1.4%); secondary sulphate (19.7% ± 2.4%); primary industrial emissions (5.4% ± 2.3%); traffic and secondary nitrate (17.0% ± 3.9%). The plant is likely to contribute to both sources, the industrial and the traffic plus secondary nitrate.

A meta-regression of the impact of policy on the efficacy of individual placement and support.

OBJECTIVE: Individual placement and support (IPS) has shown consistently better outcomes on competitive employment for patients with severe mental illness than traditional vocational rehabilitation. The evidence for efficacy originates from few countries, and generalization to different countries has been questioned. This has delayed implementation of IPS and led to requests for country-specific RCTs. This meta-analysis examines if evidence for IPS efficacy can be generalized between rather different countries. METHODS: A systematic search was conducted according to PRISMA guidelines to identify RCTs. Overall efficacy was established by meta-analysis. The generalizability of IPS efficacy between countries was analysed by random-effects meta-regression, employing country- and date-specific contextual data obtained from the OECD and the World Bank. RESULTS: The systematic review identified 27 RCTs. Employment rates are more than doubled in IPS compared with standard vocational rehabilitation (RR 2.07 95% CI 1.82-2.35). The efficacy of IPS was marginally moderated by strong legal protection against dismissals. It was not moderated by regulation of temporary employment, generosity of disability benefits, type of integration policies, GDP, unemployment rate or employment rate for those with low education. CONCLUSIONS: The evidence for efficacy of IPS is very strong. The efficacy of IPS can be generalized between countries.

The impact of carbapenemase-producing Enterobacteriaceae colonization on infection risk after liver transplantation: a prospective observational cohort study.

OBJECTIVE: To investigate the impact of colonization with carbapenemase-producing Enterobacteriaceae (CPE) on the CPE infection risk after liver transplantation (LT). METHODS: Prospective cohort study of all adult patients undergoing LT at our centre over an 8-year period (2010-2017). Individuals were screened for CPE colonization by rectal swabs at inclusion onto the waiting list, immediately before LT and weekly after LT until hospital discharge. Asymptomatic carriers did not receive decolonization, anti-CPE prophylaxis or pre-emptive antibiotic therapy. Participants were followed up for 1 year after LT. RESULTS: We analysed 553 individuals who underwent a first LT, 38 were colonized with CPE at LT and 104 acquired colonization after LT. CPE colonization rates at LT and acquired after LT increased significantly over the study period: incidence rate ratios (IRR) 1.21 (95% CI 1.05-1.39) and 1.17 (95% CI 1.07-1.27), respectively. Overall, 57 patients developed CPE infection within a median of 31 (interquartile range 11-115) days after LT, with an incidence of 3.05 cases per 10 000 LT-recipient-days and a non-significant increase over the study period (IRR 1.11, 95% CI 0.98-1.26). In multivariable analysis, CPE colonization at LT (hazard ratio (HR) 18.50, 95% CI 6.76-50.54) and CPE colonization acquired after LT (HR 16.89, 95% CI 6.95-41.00) were the strongest risk factors for CPE infection, along with combined transplant (HR 2.60, 95% CI 1.20-5.59), higher Model for End-Stage Liver Disease at the time of LT (HR 1.03, 95% CI 1.00-1.07), prolonged mechanical ventilation (HR 2.63, 95% CI 1.48-4.67), re-intervention (HR 2.16, 95% CI 1.21-3.84) and rejection (HR 2.81, 95% CI 1.52-5.21). CONCLUSIONS: CPE colonization at LT or acquired after LT were the strongest predictors of CPE infection. Prevention strategies focused on LT candidates and recipients colonized with CPE should be investigated.