Sclerotherapy for hemorrhoidal disease: systematic review and meta-analysis.

BACKGROUND: This systematic review and meta-analysis aimed to evaluate the safety and efficacy of sclerotherapy methods for hemorrhoidal disease (HD) over the past 40 years. METHODS: The review followed the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A comprehensive literature search was conducted, including studies reporting the use of sclerotherapy in patients with HD. Study eligibility criteria were defined, and data were extracted independently by the authors. Random-effects meta-analyses were performed to assess outcomes of interest. RESULTS: Out of 1965 records identified, 44 studies met the inclusion criteria, involving 9729 patients. The majority of studies were conducted in Japan, followed by the UK, Italy, and Portugal. The median age of participants was 52 years, and the majority were male. The Goligher grade distribution indicated varying degrees of HD severity. Sclerotherapy was predominantly administered through anoscopy, with polidocanol being the most commonly used agent. The procedure was generally performed without pre-injection analgesia. The meta-analysis of 14 randomized controlled trials (RCTs) revealed that sclerotherapy was not inferior to control interventions in terms of success rate (risk ratio [RR] 1.00, 95% CI 0.71-1.41) and recurrence rate (RR 1.11, 95% CI 0.69-1.77), while resulting in fewer complications (RR 0.46, 95% CI 0.23-0.92). CONCLUSIONS: This systematic review highlights the safety and efficacy of sclerotherapy for HD, which yields similar success rates and fewer complications compared to other conservative or surgical approaches. Further research is warranted to optimize sclerotherapy techniques and evaluate long-term outcomes. REGISTRATION: PROSPERO 2023 CRD42023396910.

Five-year recurrence after endoscopic approach to pilonidal sinus disease: A multicentre experience.

PURPOSE: The aim of this study was to evaluate the 5-year recurrence rate of pilonidal sinus disease (PSD) after endoscopic sinusectomy and identify risk factors for recurrence. METHODS: All consecutive patients from September 2011 through December 2017 who underwent endoscopic sinusectomy at seven referral centres for pilonidal sinus treatment were retrospectively analysed from a prospectively maintained database. RESULTS: Out of 290 patients (185 males versus 105 female, with a mean age of 25.5±6.9), 73 presented recurrence at 5-year follow-up with a recurrence rate of 25.2%. The number of pilonidal sinus with pits off the midline (p = 0.001) and the mean (SD) distance from the most lateral orifice to the midline (p = 0.001) were higher in the group of patients with recurrence at 5-year follow-up. Multivariate analysis demonstrated that the position of the pits off the midline (p = 0.001) and the distance of the most lateral orifice from the midline (p = 0.001) were independent risk factors for recurrence at 5-year follow-up. Receiver operating characteristic (ROC) curve analysis showed that the distance of lateral orifice from midline predicted an 82.2% possibility of recurrence at 5-year follow-up and Youden's test identified the best cut-off as 2 cm for this variable. Out of 195 cases with the most lateral orifice less than 2 cm from the midline, 13 presented recurrence at 5-year follow-up with a recurrence rate of 6.7%. Out of 95 cases with the most lateral orifice more than 2 cm from midline, 60 showed recurrence at 5-year follow-up with a recurrence rate of 63.2%. CONCLUSIONS: This data may help guide which disease characteristics predict the optimal use of an endoscopic pilonidal sinus technique.

Cardiovascular risk and the COVID-19 pandemic: A retrospective observational study in a population of healthcare professionals.

BACKGROUND AND AIM: To contain the spread of COVID-19, many countries imposed several restrictive measures, leading to radical changes in daily life behaviors. Healthcare workers experienced additional stress due to the increased risk of contagion, possibly causing an increase in unhealthy habits. We investigated changes in cardiovascular (CV) risk assessed by the SCORE-2 in a healthy population of healthcare workers during the COVID-19 pandemic; an analysis by subgroups was also conducted (sportspeople vs sedentary subjects). METHODS AND RESULTS: We compared medical examination and blood tests in a population of 264 workers aged over 40, performed yearly before (T0) and during the pandemic (T1, T2). We found a significant increase in the average CV risk, according to SCORE-2, during the follow-up in our healthy population, with a shift from a mean low-moderate risk profile at T0 (2.35%) to a mean high-risk profile at T2 (2.80%). Furthermore, in sedentary subjects was observed a greater and early increase in SCORE-2 compared to sportspeople. CONCLUSIONS: Since 2019, we observed an increase in CV risk profile in a healthy population of healthcare workers, particularly in sedentary subjects, highlighting the need to reassess SCORE-2 every year to promptly treat high-risk subjects, according to the latest Guidelines.

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.

High efficiency particulate air filters and heat & moisture exchanger filters increase positive end-expiratory pressure in helmet continuous positive airway pressure: A bench-top study.

BACKGROUND: Helmet continuous positive airway pressure (CPAP) has been widely used during the COVID-19 pandemic. Specific filters (i.e. High Efficiency Particulate Air filter: HEPA; Heat & Moisture Exchanger Filter: HMEF) were used to prevent Sars-CoV2 environmental dispersion and were connected to the CPAP helmet. However, HEPA and HMEF filters may act as resistors to expiratory gas flow and increase the levels of pressure within the hood. METHODS: In a bench-top study, we investigated the levels of airway pressure generated by different HEPA and HMEF filters connected to the CPAP helmet in the absence of a Positive End Expiratory Pressure (PEEP) valve and with two levels of PEEP (5 and 10 cmH2O). All steps were performed using 3 increasing levels of gas flow (60, 80, 100 L/min). RESULTS: The use of 8 different commercially available filters significantly increased the pressure within the hood of the CPAP helmet with or without the use of PEEP valves. On average, the increase of pressure above the set PEEP ranged from 3 cmH2O to 10 cmH2O across gas flow rates of 60 to 100 L/min. The measure of airway pressure was highly correlated between the laboratory pressure transducer and the Helmet manometer. Bias with 95% Confidence Interval of Bias between the devices was 0.7 (-2.06; 0.66) cmH2O. CONCLUSIONS: The use of HEPA and HMEF filters placed before the PEEP valve at the expiratory port of the CPAP helmet significantly increase the levels of airway pressure compared to the set level of PEEP. The manometer can detect accurately the airway pressure in the presence of HEPA and HMEF filters in the helmet CPAP and its use should considered.

A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM).

BACKGROUND: The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids. METHODS: A multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year. RESULTS: There were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

LOCAL DIAGNOSTIC REFERENCE LEVELS FOR PEDIATRIC RETROGRADE WEDGE PORTOGRAPHY INTERVENTIONAL PROCEDURES USING A DOSE MONITORING SOFTWARE AT A TRANSPLANTATION INSTITUTE.

The aim of this work was to establish local diagnostic reference levels (DRLs) for retrograde wedge portography (RWP) performed on pediatric patients assessing the usefulness of radiation dose monitoring software in the establishing process. Between September 2016 and April 2020, 66 consecutive RWP were performed at a transplantation institute and were included in our study. Patients were divided in three groups according to age: n = 25 infants, n = 20 middle childhood and n = 21 early adolescence. The third quartile of both Air Kerma at the reference point (Ka,r) and air kerma-area product (PKA) were evaluated to establish local DRLs (lDRLs). In addition, to control high Ka,r levels during procedures, the software notified to operators if Ka,r exceeded the dose 'alert' threshold set at 2 Gy. lDRLs were established for all three groups using PKA and Ka,r: infant group: 5.6 Gy.cm 2 and 0.034 Gy; middle childhood: 6.4 Gy.cm2 and 0.018 Gy and early adolescence: 12.8 Gy.cm2 and 0.059 Gy. The dose threshold 'alert' was never encountered (alert quota: 0%). The dose monitoring system supports the feasibility of accurate and easier lDRLs' establishment.

Is the Goligher classification a valid tool in clinical practice and research for hemorrhoidal disease?

BACKGROUND: The most widely used classification for hemorrhoidal disease (HD) is the Goligher classification, which ranks presence and severity of prolapse in four grades. Since physicians base this gradation on medical history and physical examination, it might be prone to interobserver variability. Furthermore, the gradation impacts the treatment of choice which makes reproducibility of utmost importance. The aim of this study was to determine the interobserver variability of Goligher classification among surgeons in the Netherlands. METHODS: A single-choice survey was used. The first part consisted of questions concerning baseline characteristics and the use of the Goligher classification in routine clinical practice. In the second part, to assess interobserver variability, we asked gastrointestinal surgeons and residents who routinely treat HD to review 25 photographs (with given timing as during rest or push) of patients with HD and classify the gradation using the Goligher classification. The survey was sent by email on April 19, 2021 and was available online until July 5, 2021. Interobserver variability was assessed using Fleiss' Kappa test. RESULTS: A total of 329 gastrointestinal surgeons, fellows and residents were sent an invitation email, of whom 95 (29%) completed the survey. Among the respondents, 87% indicated that they use the Goligher classification in clinical practice. Eighty-one percent found the classification helpful and 63% classified HD according to Goligher and followed the guidelines for treatment of HD accordingly. The interobserver variability showed an overall fair strength of agreement, with a Fleiss' Kappa (κ) of 0.376 (95% CI 0.373-0.380). There was a moderate agreement for grade I and IV HD with a κ statistic of 0.466 and 0.522, respectively. For grades II and III, there was a lower (fair) strength of agreement with 0.206 and 0.378, respectively. CONCLUSIONS: The fair interobserver variability is disappointing and demonstrates the need for a more reliable, and internationally accepted, classification for HD. A new classification should enable more uniformity in treating HD and in comparing outcomes of future trials and prospective registries. The protocol for a Delphi study for a new classification system is currently being prepared and led by an international research group.

Pregnancy outcomes in patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis receiving ixekizumab.

BACKGROUND: Psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) are chronic inflammatory diseases that often affect women of childbearing age. Detailed information about pregnancy and related outcomes across these indications in patients exposed to ixekizumab is lacking. OBJECTIVES: To evaluate pregnancy outcomes after maternal or paternal exposure to ixekizumab in patients with psoriasis, PsA, or axSpA. METHODS: Pregnancy cases from clinical trials and post-marketing reports, associated with either maternal or paternal exposure to ixekizumab cumulatively through 22 March 2019, were identified in the Eli Lilly Global Safety Database and described separately. RESULTS: One hundred and ninety-three ixekizumab-exposed pregnancies were identified. Maternal exposure occurred in 51.3% of pregnancies (clinical trials: n = 58; post-marketing: n = 41). The majority of paternal exposure pregnancies occurred in clinical trials (91 of 94). Live births were reported for 53.8 and 61.1% of known outcomes in maternal exposure pregnancies during clinical trials and post-marketing surveillance, respectively. No congenital malformations resulting from maternal exposure were reported in clinical trials: one case, not causally related to ixekizumab therapy, was recorded in the post-marketing setting. CONCLUSIONS: This integrated safety analysis provides relevant information for clinicians treating patients with psoriasis, PsA, or axSpA with ixekizumab. No new safety signals were identified in patients receiving ixekizumab.

Global parental leave in surgical careers: differences according to gender, geographical regions and surgical career stages.

BACKGROUND: There is a lack of information regarding the provision of parental leave for surgical careers. This survey study aims to evaluate the experience of maternity/paternity leave and views on work-life balance globally. METHODS: A 55-item online survey in 24 languages was distributed via social media as per CHERRIES guideline from February to March 2020. It explored parental leave entitlements, attitude towards leave taking, financial impact, time spent with children and compatibility of parenthood with surgical career. RESULTS: Of the 1393 (male : female, 514 : 829) respondents from 65 countries, there were 479 medical students, 349 surgical trainees and 513 consultants. Consultants had less than the recommended duration of maternity leave (43.8 versus 29.1 per cent), no paid maternity (8.3 versus 3.2 per cent) or paternity leave (19.3 versus 11.0 per cent) compared with trainees. Females were less likely to have children than males (36.8 versus 45.6 per cent, P = 0.010) and were more often told surgery is incompatible with parenthood (80.2 versus 59.5 per cent, P < 0.001). Males spent less than 20 per cent of their salary on childcare and fewer than 30 hours/week with their children. More than half (59.2 per cent) of medical students did not believe a surgical career allowed work-life balance. CONCLUSION: Surgeons across the globe had inadequate parental leave. Significant gender disparity was seen in multiple aspects.

Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of pilonidal disease.

Pilonidal disease (PD) is a relatively common, benign but challenging condition of the natal cleft. This consensus statement was drawn up by a panel of surgeons, identified by the Italian Society of Colorectal Surgery (SICCR) as having a "special interest" in PD, with the aim of recommending the best therapeutic options according to currently available scientific evidence. A three-step modified-Delphi process was adopted, implying: (1) choice of the panelists; (2) development of a discussion outline and of target issues; and (3) a detailed systematic review of the current literature. The agreement/disagreement level was scored on a five-point Likert scale as follows: "A + : strongly agree; A-: agree; N: unsure/no opinion; D-: disagree; D + : strongly disagree. Each panelist contributed to the production of this manuscript, and the final recommendations were reviewed by the Clinical Practice Guidelines Committee.

A step-by-step approach to endorectal proctopexy (ERPP): how we do it.

There are many surgical treatments aimed at correcting internal mucosal prolapse and rectocele associated with obstructed defecation syndrome (ODS). Perineal procedures can be considered as first options in young men in whom an abdominal approach poses risks of sexual dysfunction and in selected women with isolated posterior compartment prolapse who failed conservative treatment. About 20 years ago, we described endorectal proctopexy (ERPP) also known as internal Delorme procedure. The aim of the present study was to describe, with attention to technical details and the aid of a video, the different steps of ERPP for the treatment of ODS. A retrospective analysis of our last 100 cases confirms our initial good results. Complications included suture line dehiscence with consequent stricture in four patients (4%). Bleeding occurred in four (4%) patients and was conservatively treated. Transient anal continence impairment consisting of urgency and soiling occurred in 12 (12%) and 6 (6%) patients, respectively. At 6-month follow-up the Cleveland Clinic Constipation Score and ODS score improved from a median preoperative value of 18.9 and 18.5 to 5 and 5, respectively (p < 0.0001). The mean follow-up was 36.05 ± 13.3 (range 12-58) months and anatomical recurrence rate was 6 (%). Due to its excellent safety profile and the ability to tailor the procedure to different disease presentations, we think that ERPP should be part of the basic armamentarium of all colorectal surgeons operating on the pelvic floor.

Obstructed defaecation syndrome: European consensus guidelines on the surgical management.

Clinical decision-making in the treatment of patients with obstructed defaecation remains controversial and no international guidelines have been provided so far. This study reports a consensus among European opinion leaders on the management of obstructed defaecation in different possible clinical scenarios.

A machine learning approach to predict healthcare-associated infections at intensive care unit admission: findings from the SPIN-UTI project.

BACKGROUND: Identifying patients at higher risk of healthcare-associated infections (HAIs) in intensive care units (ICUs) represents a major challenge for public health. Machine learning could improve patient risk stratification and lead to targeted infection prevention and control interventions. AIM: To evaluate the performance of the Simplified Acute Physiology Score (SAPS) II for HAI risk prediction in ICUs, using both traditional statistical and machine learning approaches. METHODS: Data for 7827 patients from the 'Italian Nosocomial Infections Surveillance in Intensive Care Units' project were used in this study. The Support Vector Machines (SVM) algorithm was applied to classify patients according to sex, patient origin, non-surgical treatment for acute coronary disease, surgical intervention, SAPS II at admission, presence of invasive devices, trauma, impaired immunity, and antibiotic therapy in 48 h preceding ICU admission. FINDINGS: The performance of SAPS II for predicting HAI risk provides a receiver operating characteristic curve with an area under the curve of 0.612 (P<0.001) and accuracy of 56%. Considering SAPS II along with other characteristics at ICU admission, the SVM classifier was found to have accuracy of 88% and an AUC of 0.90 (P<0.001) for the test set. The predictive ability was lower when considering the same SVM model but with the SAPS II variable removed (accuracy 78%, AUC 0.66). CONCLUSIONS: This study suggested that the SVM model is a useful tool for early prediction of patients at higher risk of HAIs at ICU admission.

Markers of Cardiotoxicity in Early Breast Cancer Patients Treated With a Hypofractionated Schedule: A Prospective Study.

PURPOSE: To evaluate, in a series of early breast cancer (BC) patients treated with hypofractionated adjuvant radiotherapy (RT), whether N-terminal-pro hormone B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I assay measurements can predict acute clinical or preclinical cardiotoxicity. PATIENTS AND METHODS: The study comprised 44 consecutive patients, who underwent conservative surgery with or without (neo)adjuvant chemotherapy and hypofractionated adjuvant RT. The RT schedule consisted in a total dose of 42.4 Gy in 16 fractions administered 5 days per week. Twenty-one patients received a subsequent boost to the tumor bed consisting of a total dose of 10 Gy in 4 fractions delivered via a direct electron field. All patients underwent 12-lead electrocardiogram, echocardiogram, and cardiac clinical examinations before RT to assess cardiovascular risk factors; these examinations were repeated yearly for 5 consecutive years. High-sensitivity cardiac troponin I and NT-proBNP were analyzed from serum samples at baseline, after delivery of the fourth and 16th RT fractions, and 12 months after treatment completion. RESULTS: No increase in cardiac troponin I and B-type natriuretic peptide levels related to left breast irradiation was observed. No statistical difference in NT-proBNP and high-sensitivity troponin I levels between left- and right-sided BC was found. An increase was observed of B-type natriuretic peptide levels at baseline, during treatment, and until 12 months after RT related to hypertension, with the P value near to the .05 threshold for age and chemotherapy. CONCLUSION: Conformational hypofractionated RT in left-sided BC may not cause acute myocardial damage. Early cardiac screening may be used to identify patients with cardiologic risk factors, patients who are older than 60 years, and patients who received chemotherapy that could result in clinically relevant cardiac pathologies.