European Society of Coloproctology: Guidelines for diagnosis and treatment of cryptoglandular anal fistula.

AIM: The primary aim of the European Society of Coloproctology (ESCP) Guideline Development Group (GDG) was to produce high-quality, evidence-based guidelines for the management of cryptoglandular anal fistula with input from a multidisciplinary group and using transparent, reproducible methodology. METHODS: Previously published methodology in guideline development by the ESCP has been replicated in this project. The guideline development process followed the requirements of the AGREE-S tool kit. Six phases can be identified in the methodology. Phase one sets the scope of the guideline, which addresses the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula in adult patients presenting to secondary care. The target population for this guideline are healthcare practitioners in secondary care and patients interested in understanding the clinical evidence available for various surgical interventions for anal fistula. Phase two involved formulation of the GDG. The GDG consisted of 21 coloproctologists, three research fellows, a radiologist and a methodologist. Stakeholders were chosen for their clinical and academic involvement in the management of anal fistula as well as being representative of the geographical variation among the ESCP membership. Five patients were recruited from patient groups to review the draft guideline. These patients attended two virtual meetings to discuss the evidence and suggest amendments. In phase three, patient/population, intervention, comparison and outcomes questions were formulated by the GDG. The GDG ratified 250 questions and chose 45 for inclusion in the guideline. In phase four, critical and important outcomes were confirmed for inclusion. Important outcomes were pain and wound healing. Critical outcomes were fistula healing, fistula recurrence and incontinence. These outcomes formed part of the inclusion criteria for the literature search. In phase five, a literature search was performed of MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews by eight teams of the GDG. Data were extracted and submitted for review by the GDG in a draft guideline. The most recent systematic reviews were prioritized for inclusion. Studies published since the most recent systematic review were included in our analysis by conducting a new meta-analysis using Review manager. In phase six, recommendations were formulated, using grading of recommendations, assessment, development, and evaluations, in three virtual meetings of the GDG. RESULTS: In seven sections covering the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula, there are 42 recommendations. CONCLUSION: This is an up-to-date international guideline on the management of cryptoglandular anal fistula using methodology prescribed by the AGREE enterprise.

Intraoperative Ultrasound-Guided Conserving Surgery for Breast Cancer: No More Time for Blind Surgery.

BACKGROUND: Breast-conserving surgery (BCS) still remains a blind surgery despite all available tumor localization methods. Intraoperative ultrasound (IOUS) allows real-time visualization during all resection phases. METHODS: This was a prospective observational cohort study conducted at the Veneto Institute of Oncology between January 2021 and June 2022. Patients with ductal carcinoma in situ, T1-2 invasive cancer, or post-neoadjuvant tumors, suitable for BCS, were recruited. All breast cancer lesion types were included, i.e. solid palpable, solid non-palpable, non-solid non-palpable, and post-neoadjuvant treatment residual lesions. Eligible participants were randomly assigned to either IOUS or traditional surgery (TS) in a 1:1 ratio. The main outcomes were surgical margin involvement, reoperation rate, closest margin width, main specimen and cavity shaving margin volumes, excess healthy tissue removal, and calculated resection ratio (CRR). RESULTS: Overall, 160 patients were enrolled: 80 patients were allocated to the TS group and 80 to the IOUS group. IOUS significantly reduced specimen volumes (16.8 cm3 [10.5-28.9] vs. 24.3 cm3 [15.0-41.3]; p = 0.015), with wider closest resection margin width (2.0 mm [1.0-4.0] vs. 1.0 mm [0.5-2.0] after TS; p < 0.001). Tumor volume to specimen volume ratio was significantly higher after IOUS (4.7% [2.5-9.1] vs. 2.9% [0.8-5.2]; p < 0.001). IOUS yielded significantly better CRR (84.5% [46-120.8] vs. 114% [81.8-193.2] after TS; p < 0.001), lower involved margin rate (2.5 vs. 15%; p = 0.009) and reduced re-excision rate (2.5 vs. 12.5%; p = 0.032). CONCLUSIONS: IOUS allows real-time resection margin visualization and continuous control during BCS. It showed clear superiority over TS in both oncological and surgical outcomes for all breast cancer lesion types. These results disfavor the paradigm of blind breast surgery.

An international survey exploring the management of pilonidal disease.

AIM: Pilonidal disease (PD) is a common debilitating condition frequently seen in surgical practice. Several available treatments carry different benefit/risk balances. The aim of this study was to snapshot the current management of PD across European countries. METHOD: Members affiliated to the European Society of Coloproctology were invited to join the survey. An invitation was extended to others via social media. The predictive power of respondents' and hospitals' demographics on the change of therapeutic approach was explored. RESULTS: Respondents (n = 452) were mostly men (77%), aged 26-60 years, practising in both academic and public hospitals and with fair distribution between colorectal (51%) and general (48%) surgeons. A total of 331 (73%) respondents recommended surgery at first presentation of the disease. Up to 80% of them recommended antibiotic therapy and 95% did not use any classification of PD. A primary closure technique was the preferred procedure (29%), followed by open technique (22%), flap creation (7%), sinusectomy (7%) and marsupialization (7%). Approximately 27% of subjects would choose the same surgical technique even after a failure. Almost half (46%) perform surgery as office based. A conservative approach was negatively associated with acutely presenting PD (p < 0.001). Respondents who were not considering tailored surgery based on patient presentation tended to change their approach in the case of a failed procedure. CONCLUSION: With the caveat of a heterogeneous number of respondents across countries, the results of our snapshot survey may inform the development of future guidelines.

Endoscopic sinusectomy: 'a rose by any other name'. A systematic review of different endoscopic procedures to treat pilonidal disease.

AIM: Pilonidal sinus or Pilonidal Disease (PD) is a relatively common, benign but challenging condition. Although commonly encountered in practice, its ideal treatment is controversial. One of the most validated treatments is video-assisted surgery. In this context, very similar endoscopic techniques have been published under different names. The aim of this systematic review is to assess the differences among these proposed techniques and their outcomes. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed during all stages of this systematic review. A systematic search of the English literature was performed on multiple databases from 1 January 2014 to 3 April 2022. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measures were the adherence to the IDEAL reporting guidelines, the Blencowe framework and the core outcome set (COS) for studies evaluating the introduction and evaluation of novel surgical techniques, the qualitative assessment using appropriate tools, the procedural variations and outcomes of each technique. RESULTS: A total of 38 articles were included reporting a very similar technique under eight different acronyms. The number of patients varied from 9 to 250. Mean follow-up ranged from 1 to 60 months. There was only one published study of IDEAL 3. The majority (58%) were IDEAL 2a studies. Reporting of domains in the IDEAL reporting guidelines and Blencowe framework was poor, with most studies not reporting the component steps of procedures or efforts to standardize them. Half of COS domains were markedly underreported. The quality of the evidence was categorized as having a risk of bias from moderate to critical level in all nine comparative non-randomized series. Postoperative complications occurred in 0%-6% of cases, including surgical site infection, poor or failed wound healing bleeding, granuloma, haematoma, and pain requiring intervention. The recurrence rate varied from 0% to 22%. CONCLUSION: The study demonstrates that reporting on technical aspects of interventions for PD is poor, thus warranting a better-quality control of surgical techniques. It is advisable to group all endoscopic procedures under the umbrella term of 'endoscopic sinusectomy', thus embracing the two main principles of this technique, that is, video assistance and PD ablation.

Long term results of video-assisted anal fistula treatment for complex anal fistula: another shattered dream?

AIM: Complex anal fistula represents a burden for patients, and its management is a challenge for surgeons. Video-assisted anal fistula treatment (VAAFT) is one sphincter-sparing technique. However, data on its long-term effectiveness are scant. We aimed to explore the outcomes of VAAFT in a retrospective cohort of patients referred to a tertiary centre. METHOD: Consecutive adult patients with a minimum of 2 years' follow-up after VAAFT were reviewed. Patients were followed up to 5 years postoperatively. Failure was defined as incomplete healing of the external orifice(s) during the first 6 months. Recurrence was defined as new radiologically and/or clinically confirmed onset of the fistula after primary healing. A generalized linear model was fitted to evaluate the association between failure and sociodemographic characteristics. Predictors of recurrence were determined in a subgroup analysis of patients found to be free from disease at 6 months postoperatively. RESULTS: Overall, 106 patients (70% male; mean age 41 years) were reviewed. Of these 86% had a previous seton placement. Fistulas were either high trans-sphincteric (74%), suprasphincteric (12%) or extrasphincteric (13%). Eight (7%) patients experienced postoperative complications, none of which required reintervention. Mean follow-up was 53 ± 13.2 months. VAAFT failed in 14 (13%) patients. The overall recurrence rate ranged from 29% at 1 year to 63% at 5 years. Multiple external orifices, suprasphincteric fistula, younger age, previous surgery and higher complexity of the fistulous tract were independent risk factors for recurrence. CONCLUSION: VAAFT is a safe sphincter-sparing technique. The initially high success rate decreases over time and relates to a higher degree of complexity.

Efficacy and safety of Propionibacterium extract gel versus glyceryl trinitrate ointment in the treatment of chronic anal fissure: a randomized controlled trial.

AIM: Chronic anal fissure (CAF) is an extremely frequent finding in clinical practice. Several topical agents have been proposed for its treatment with the common goal of increasing anodermal blood flow to promote healing. The aim of this study was to compare the efficacy and safety of a Propionibacterium extract gel (PeG) and 0.4% glyceryl trinitrate ointment (GTN) in patients with CAF. METHOD: Patients were randomly allocated to a PeG or GTN group and medication was administered every 12 h for 40 days. The primary outcome was the success rate, as measured by a decrease in the REALISE scoring system for anal fissure at 10, 20 and 40 days after initiating either treatment. The secondary outcomes recorded at the same time points were healing rate, visual analogue scales for itching and burning, rate of complications and adverse events, patient quality of life and satisfaction, and cost analysis. RESULTS: A total of 120 patients were enrolled, and 96 patients (PeG, n = 53; GTN, n = 43) completed the primary outcomes. A significant decrease over time in the REALISE score was observed in both groups. Adverse events occurred more frequently in the GTN group than in the PeG group, peaking at visit 1 [37 (63.8%) vs. 2 (3.4%), respectively], with headache being the most prevalent. The between-treatment cumulative average costs per patient were significantly higher for GTN than that for PeG at each follow-up visit. There were no other significant differences between the two groups for any of the other outcomes. CONCLUSION: While there was no difference in healing rates between the two treatments, PeG was more cost-effective and associated with fewer adverse events.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial.

AIM: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST). METHOD: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention. The inclusion criteria were age 18-70 years; attending specialist hospitals in England; self-reported constipation for >6 months; refractory to basic treatment. The main exclusions were secondary constipation and previous experience of the trial interventions. The primary outcome was the mean change in Patient Assessment of Constipation Quality of Life score at 6 months on intention to treat. The secondary outcomes were validated disease-specific and psychological questionnaires and cost-effectiveness (based on EQ-5D-5L). RESULTS: In all, 182 patients were randomized 3:3:2 (target 384): HT n = 68; HTBF n = 68; INVEST-guided treatment n = 46. All interventions had similar reductions (improvement) in the primary outcome at 6 months (approximately -0.8 points of a 4-point scale) with no statistically significant difference between HT and HTBF (-0.03 points; 95% CI -0.33 to 0.27; P = 0.85) or INVEST versus no-INVEST (0.22; -0.11 to 0.55; P = 0.19). Secondary outcomes showed a benefit for all interventions with no evidence of greater cost-effectiveness of HTBF or INVEST compared with HT. CONCLUSION: The results of the study at 6 months were inconclusive. However, with the caveat of under-recruitment and further attrition at 6 months, a simple, cheaper approach to intervention may be as clinically effective and more cost-effective than more complex and invasive approaches.

First-line steroid treatment for spontaneous intracranial hypotension.

BACKGROUND: Spontaneous intracranial hypotension (SIH) is a syndrome characterized by low cerebrospinal fluid (CSF) pressure and postural headaches, and affects 1 per 20,000 individuals every year. CASE REPORT: We report an otherwise healthy 38-year-old man admitted to the hospital with orthostatic headache that developed 48 h after a short-haul flight during which he sustained a neck injury due to turbulence. Neurological examination, blood analysis and computed tomography scan performed at the emergency service were normal. Brain and spine magnetic resonance imaging (MRI) showed diffuse pachymeningeal enhancement and contrast medium egress from the subarachnoid space into the epidural space at the level of C2. The patient was treated with bed rest, hydration and 1 mg/kg/day oral prednisone for 5 days, with a gradual withdrawal in the following 7 days. Complete symptomatic relief was observed after 16 days, with resolution of the pathological findings on brain and spinal MRI after 1 month, except for localized pachymeningeal enhancement. Clinical relief was maintained over time until last follow-up visit 9 months later. CONCLUSION: Successful conservative treatment barely exceeds one quarter of cases of SIH. The clinical benefits of steroids may result from several mechanisms of action, for example, improving brain oedema and inflammation, determining fluid retention, and facilitating reabsorption of the CSF from extradural space. Notwithstanding that epidural blood patch remains the most successful treatment for SIH, future studies should explore the effectiveness of steroids as first-line therapy in addition to the most commonly suggested measures of bed rest and hydration.

Anoplasty for anatomical anal stenosis: systematic review of complications and recurrences.

AIM: The optimal surgical treatment for anatomical anal stenosis (AS) remains to be determined. The aim of this study was to determine the rates of complications and recurrence after anoplasty for anatomical AS and, wherever feasible, compare the outcomes for the various techniques. METHOD: A PROSPERO-registered systematic review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Medline, PubMed, Embase, Cochrane Library of Systematic Review, Scopus and Web of Science were searched for articles published up to May 2021. Studies that assessed the outcomes of anoplasty in adult patients with anatomical AS were selected. The primary outcomes were complications and recurrence. The methodological quality of studies was appraised using the Joanna Briggs Institute critical appraisal tools. RESULTS: From the total of 2705 unique screened records, 151 were assessed for eligibility. Only 29 studies (two prospective) met the inclusion criteria, reporting data on 556 patients [mean age 53 (18-83) years, 46% female]. Previous history of surgery for haemorrhoidal disease accounted for three quarters of cases. A total of 14 types of anoplasty were found, with the Y-V flap being the most performed technique [27% of cases (n = 149)]. Complications frequently occurred, with a pooled prevalence of 10.2% (95% CI 3.9%-24.1%) after Y-V flap and 11.5% (5.3%-23.0%) after rhomboid/diamond flap. Patients undergoing house flap achieved better results in terms of clinical improvement, satisfaction and quality of life compared with Y-V flap and rhomboid/diamond flap. When considering only studies with at least 12 months of follow-up, the pooled prevalence of recurrence was 4.7% (2.2%-9.8%), with significantly higher rates observed in the prospective versus retrospective series [pooled prevalence 18.9% (11.5%-29.5%) vs. 3.6% (1.7-7.8%), respectively; p < 0.001]. CONCLUSION: Both complications and recurrence were significantly lower after house flap compared with rhomboid/diamond and Y-V flap. Better designed multicentre studies with longer follow-up are needed to confirm these findings. PROSPERO REGISTRATION NUMBER: CRD42021239493.

Living with cryptoglandular anal fistula: a qualitative investigation of the patient's experience through semi-structured patient interviews.

PURPOSE: Cryptoglandular anal fistula continues to be a subject of extensive surgical research due to the lack of effective and enduring treatments, some of which incur risks to continence and quality of life. However, the patient experience of disease has seldom been reported. The aims of this study are to understand the impact of living with a fistula and the treatment outcomes that are valued by patients. METHODS: Patients with cryptoglandular anal fistula were recruited using purposive sampling from two tertiary referral centres in the UK and the Netherlands. Patients underwent semi-structured interviews that were audio-recorded and transcribed verbatim. Dutch transcripts were translated into English and underwent independent, thematic analysis using open coding by two study team members to identify common themes and sub-themes. RESULTS: Twenty interviews were conducted before saturation was reached (11 male, median age 49, Interquartile range 39-55 years). Four broad themes emerged, covering the physical symptoms of fistula, the patient journey towards understanding the condition, life impact, and treatment. Several inter-related sub-themes were found, reflecting the extensive impact and adjustment that the disease entails. CONCLUSION: The impact of cryptoglandular anal fistula extends beyond the physical symptoms of pain and discharge, requires significant readjustment, and often negatively impacts psycho-social wellbeing. These aspects of disease should receive greater attention in future assessment of treatment and quality of life.

Long-Term Outcomes of Sectorial Longitudinal Augmented Prolapsectomy for Asymmetric Muco-hemorrhoidal Prolapse: An Observational Study of 433 Consecutive Patients.

PURPOSE: Hemorrhoidal disease (HD) is a widespread condition severely influencing patients' quality of life. Recently, the large diffusion of stapled hemorrhoidopexy has revealed a new unexpected pathological entity: the asymmetric mucosal prolapse. We aimed to assess the outcomes of the sectorial longitudinal augmented prolapsectomy (SLAP), a technique dedicated to asymmetric prolapse, in terms of HD symptoms, prolapse recurrence, and rectal stenosis. METHODS: Patients affected by III-IV-degree symptomatic HD with asymmetric mucosal prolapse undergone SLAP of 1 or 2 hemorrhoidal columns (SLAP1 or SLAP2) were retrospectively assessed. The severity of hemorrhoid symptoms and fecal continence status were evaluated before and after surgery. Mean outcome was evaluation of medium-long-term outcomes as the occurrence of recurrence and anal or rectal stenosis. Secondary outcome was the evaluation of postoperative bleeding, reoperation rate, length of hospitalization, fecal urgency, and time to return to work. RESULTS: We enrolled 433 patients (277 SLAP1 and 156 SLAP2). Hemorrhoidal symptoms recurrence was reported in 9 patients undergone SLAP1 and 4 patients undergone SLAP2, while prolapse recurrence occurred, respectively, in 4 and 2 patients. No major intraoperative complications occurred. An emergency reintervention for postoperative bleeding occurred in 13 cases undergone SLAP1 and in 5 patients treated with SLAP2. Fecal incontinence occurred in 8 and 4 cases of patients treated with SLAP1 and SLAP2. CONCLUSIONS: The combination of a simple hemorrhoidectomy to a mucosal rectal prolapsectomy should be part of every coloproctologist background. Promising and satisfying results can be achieved using SLAP for HD associated with asymmetric prolapse.

Systematic Characterization of Defecographic Abnormalities in a Consecutive Series of 827 Patients With Chronic Constipation.

BACKGROUND: Barium defecography can assess structural and functional abnormalities in patients with chronic constipation. OBJECTIVE: The purpose of this study was to determine the prevalence of individual and overlapping defecographic findings in this setting. DESIGN: This was a cross-sectional study. SETTINGS: The study was conducted at a university hospital tertiary GI physiology department. PATIENTS: Consecutive examinations of 827 consecutive patients presenting over a 30-month period with well-defined symptom severity (≥12 points on the Cleveland Clinic Constipation score) were included. Systematic evaluation of images with results stratified by sex is described. MAIN OUTCOME MEASURES: Six individual functional or anatomic (intussusception, rectocele, enterocele, megarectum, excessive dynamic perineal descent) defecographic observations were defined a priori, thus permitting 26 possible combinations of findings (ie, 63 abnormal types + 1 normal). RESULTS: Patients with constipation (mean symptom score = 19) were predominantly female (88%), with median age of 49 years (range, 17-98 y) . All 6 individual radiologic findings were identified with a total of 43 combinations found in the cohort; the 14 most prevalent of these accounted for >85% of patients. Only 136 patients (16.4%) had a normal defecography (34.3% males vs 13.9% females; p < 0.0001). Overall, 612 patients (74.0%) had structural (n = 508 (61.4%)) or functional (n=104 (12.6%)) abnormalities in isolation, with 79 (9.6%) others exhibiting combinations of both. Functional abnormalities in isolation were more common in males compared with females (22.5% vs11.2%; p = 0.025) as opposed to structural abnormalities (57.8% vs 85.7%; p < 0.0001). Expulsion time was longer in females compared with males (110 s (60-120 s) vs 90 s (60-120 s); p = 0.049). LIMITATIONS: The study was limited by its lack of multiorgan opacification. CONCLUSIONS: These results provide a contemporary atlas of defecographic findings in constipation. Several individual structural and functional features have been systematically classified, with overlap greater than previously acknowledged and profound differences among sexes that carry implications for tailoring management. See Video Abstract at http://links.lww.com/DCR/B552. CARACTERIZACIN SISTEMTICA DE ANOMALAS DEFECOGRFICAS EN UNA SERIE CONSECUTIVA DE PACIENTES CON ESTREIMIENTO CRNICO: ANTECEDENTES:La defecografía con bario puede evaluar anomalías estructurales y funcionales en pacientes con estreñimiento crónico.OBJETIVO:Determinar la prevalencia de hallazgos defecográficos individuales y superpuestos en este entorno.DISEÑO:Transversal.ENTORNO CLINICO:Hospital Universitario de tercer nivel, departamento de fisiología gastrointestinal.PACIENTES:Exploraciones consecutivas de 827 pacientes consecutivos que se presentaron durante un período de 30 meses con una gravedad de los síntomas bien definida (≥12 puntos en la escala de estreñimiento de la Cleveland Clinic): evaluación sistemática de imágenes con resultados estratificados por sexo.PRINCIPALES MEDIDAS DE VALORACION:Se definieron a priori seis observaciones defecográficas individuales, funcionales o anatómicas (intususcepción, rectocele, enterocele, megarecto, descenso perineal dinámico excesivo), lo que permitió 26 combinaciones posibles de hallazgos (es decir, 63 tipos anormales + 1 normal).RESULTADOS:Los pacientes con estreñimiento (puntuación media de síntomas, 19) eran predominantemente mujeres (88%) con una edad mediana de 49 (17-98) años. Se identificaron 6 hallazgos radiológicos individuales con un total de 43 combinaciones encontradas en la cohorte; los 14 más predominantes de éstos representaron >85% de los pacientes.Solo 136 (16,4%) pacientes tuvieron una defecografía normal (34,3% hombres vs. 13,9% mujeres; P < 0,0001). En general, 612 (74,0%) pacientes tenían anomalías estructurales (n = 508 [61,4%]) o funcionales (n = 104 [12,6%]) de forma aislada, y otros 79 (9,6%) presentaban combinaciones de ambas. Las anomalías funcionales aisladas fueron más comunes en los hombres en comparación con las mujeres (22,5% vs. 11,2%, P = 0,025) en comparación con las anomalías estructurales (57,8 vs. 85,7%, P < 0,0001). El tiempo de expulsión fue mayor en las mujeres en comparación con los hombres (110 [60-120] vs. 90 [60-120] segundos; P = 0,049).LIMITACIONES:Falta de opacificación multiorgánica.CONCLUSIONES:Estos resultados proporcionan un atlas contemporáneo de hallazgos defecográficos en estreñimiento. Varias características individuales, estructurales y funcionales; se han clasificado sistemáticamente, con una superposición mayor que la reconocida anteriormente y con grandes diferencias entre los sexos que tienen implicaciones para adaptar su tratamiento. Consulte Video Resumen en http://links.lww.com/DCR/B552.

A worldwide survey on proctological practice during COVID-19 lockdown (ProctoLock 2020): a cross-sectional analysis.

AIM: Proctology is one of the surgical specialties that has suffered the most during COVID-19 pandemic. Using a cross-sectional non-incentivised World Wide Web survey, we aimed to snapshot the current status of proctological practice in six world regions. METHOD: Surgeons affiliated to renowned scientific societies with an interest in coloproctology were invited to join the survey. Members of the ProctoLock Working Group enhanced recruitment by direct invitation. The predictive power of respondents' and hospitals' demographics on the change of status of surgical and outpatient activities was calculated. RESULTS: Respondents (n = 1050) were mostly men (79%), with a mean age of 46.9 years, at consultant level (79%), practising in academic hospitals (53%) offering a dedicated proctology service (68%). A total of 119 (11%) tested positive for SARS-CoV-2. The majority (54%) came from Europe. Participants from Asia reported a higher proportion of unaltered practice (17%), while those from Europe had the highest proportion of fully stopped practice (20%). The likelihood of ongoing surgical practice was higher in men (OR 1.54, 95% CI 1.13-2.09; P = 0.006), in those reporting readily availability of personal protective equipment (PPE) (OR 1.40, 1.08-1.42; P = 0.012) and in centres that were partially or not at all involved in COVID-19 care (OR 2.95, 2.14-4.09; P < 0.001). This chance decreased by 2% per year of respondent's age (P = 0.001). CONCLUSION: Several factors including different screening policies and resource capacity affected the current status of proctological practice. This information may help health authorities to formulate effective preventive strategies to limit curtailment of care of these patients during the pandemic.

Middle-term Outcomes of Gatekeeper Implantation for Fecal Incontinence.

BACKGROUND: Intersphincteric injectable bulking agents are one of the current treatment options for fecal incontinence, failing behavioral and medical therapy. Gatekeeper showed promising short-term results, but long-term outcomes are unknown. OBJECTIVE: The purpose of this study was to clinically evaluate a prospective cohort of fecal incontinence patients up to 36 months after implantation of Gatekeeper. DESIGN: This was a prospective clinical study. SETTINGS: The study was conducted at a large university tertiary care hospital. PATIENTS: Consecutive female patients were eligible if fecal incontinence onset was ≥6 months before the first visit and symptoms were refractory to standard conservative measures. INTERVENTIONS: All of the patients underwent implantation of 4 or 6 Gatekeeper prostheses. Three-dimensional endoanal ultrasonography and high-resolution anorectal manometry were performed preoperatively and postoperatively at 2 and 3 months after implantation. MAIN OUTCOME MEASURES: The Cleveland Clinic Fecal Incontinence score was calculated at baseline and 1, 3, 12, 24, and 36 months postoperatively. RESULTS: Twenty patients (all women; median age, 59 y) were enrolled, and all implants were uneventful. Postoperative endoanal ultrasonography showed normal prosthesis localization in 16 patients (80%). At manometry, mean anal resting pressure significantly improved (57.8 ± 7.5 mm Hg; p = 0.0004). Mean preoperative Cleveland Clinic Fecal Incontinence score was 12.4 ± 1.8, with significant improvements initially documented at 3 months (4.9 ± 1.5; p < 0.0001) and sustained up to 36 months (4.9 ± 1.7; p < 0.0001). Patients receiving only 4 (compared with 6) prostheses and those experiencing pudendal neuropathy (compared with those who did not) showed significantly higher Cleveland Clinic Fecal Incontinence score values in the middle term. LIMITATIONS: The study was limited by its small sample size and absence of quality-of-life data. CONCLUSIONS: Initial improvements after Gatekeeper implantation for fecal incontinence are sustained in the middle term. Accurate preoperative evaluation of coexistent clinical conditions that may negatively affect outcomes is recommended for patient selection. See Video Abstract at http://links.lww.com/DCR/B109. RESULTADOS A MEDIANO PLAZO EN LA IMPLANTACIÓN DE GATEKEEPER PARA LA INCONTINENCIA FECAL: Los agentes de volumen inyectables interesfintéricos, son opciones actuales de tratamiento para la incontinencia fecal, ante fallas de terapias conductuales y médicas. Gatekeeper mostró resultados prometedores a corto plazo, pero resultados a largo plazo aún son desconocidos.Evaluar clínicamente una cohorte prospectiva de pacientes con incontinencia fecal, hasta 36 meses después de la implantación de Gatekeeper.Estudio clínico prospectivo.El estudio se realizó en un gran hospital universitario de atención terciaria.Fueron elegibles pacientes femeninas consecutivas, si el inicio de la incontinencia fecal, fue al menos 6 meses antes de la primera visita, y que los síntomas fueron refractarios a las medidas conservadoras estandarizadas.Todas las pacientes fueron sometidas a implantación de 4 o 6 prótesis Gatekeeper. Se realizó ecografía endoanal de 3D y manometría anorrectal de alta resolución, antes de la implantación y después a los 2 y 3 meses.Se calculó el puntaje de incontinencia fecal de la Cleveland Clinic al inicio, y a los 1, 3, 12, 24 y 36 meses después de la operación.Se inscribieron veinte pacientes (todas mujeres; con edad media de 59 años), y todos los implantes transcurrieron sin incidentes. La ecografía endoanal postoperatoria, mostró localización normal de la prótesis en 16 (80%) pacientes. A la manometría, la presión media de reposo anal, mejoró significativamente (57.8 ± 7.5 mmHg, p = 0.0004). La puntuación media preoperatoria de la incontinencia fecal de la Cleveland Clinic, fue de 12.35 ± 1.75, con mejoras significativas documentadas inicialmente a los 3 meses (4.9 ± 1.5, p <0.0001) y sostenidas hasta los 36 meses (4.9 ± 1.7, p <0.0001). Los pacientes que recibieron solo 4 prótesis (en comparación con 6) y que padecían neuropatía pudenda (en comparación con aquellas que no la padecían), mostraron valores de puntaje de Incontinencia Fecal de la Clínica Cleveland, significativamente más altos en el mediano plazo.El tamaño pequeño de la muestra y la ausencia de datos en calidad de vida.Las mejoras iniciales después de la implantación de Gatekeeper para la incontinencia fecal, se mantienen en el mediano plazo. Para la selección de pacientes, se recomienda una precisa evaluación preoperatoria de las condiciones clínicas coexistentes, que puedan afectar negativamente los resultados. Consulte Video Resumen en http://links.lww.com/DCR/B109.

Impact of COVID-19 Outbreak on Healthcare Workers in Italy: Results from a National E-Survey.

Italy has been the first-hit European country to face the outbreak of coronavirus disease 2019 (COVID-19). Aim of this survey was to assess in depth the impact of the outbreak on healthcare workers (HCW). A 40-item online survey was disseminated via social media inviting Italian HCW, with questions exploring demographics, health status and work environment of respondents. A total of 527 were invited to take part in March 2020, of whom 74% (n = 388) responded to the survey. Of these, 235 (61%) were women. HCW were mostly physicians (74%), from high-prevalence regions (52%). 25% experienced typical symptoms during the last 14 days prior to survey completion, with only 45% of them being tested for COVID-19. Among the tested population, 18 (18%) resulted positive for COVID-19, with 33% being asymptomatic. Only 22% of HCW considered personal protective equipment adequate for quality and quantity. Females and respondents working in high-risk sectors were more likely to rate psychological support as useful (OR, 1.78 [CI 95% 1.14-2.78] P = 0.012, and 2.02 [1.12-3.65] P = 0.020, respectively) and workload as increased (mean increase, 0.38 [0.06-0.69] P = 0.018; and 0.54 [0.16-0.92] P = 0.005, respectively). The insights from this survey may help authorities in countries where COVID-19 epidemic has not yet broken out. Management strategies should be promptly undertaken in order to enhance safety and optimise resource allocation.

Implantable Agents for Fecal Incontinence: An Age-Matched Retrospective Cohort Analysis of GateKeeper versus SphinKeeper.

Background. We aim to evaluate morphofunctional changes of the sphincter complex after GateKeeper (GK) and SphinKeeper (SK) procedures and correlate these with symptom improvement. Methods. Ten consecutive females undergoing SK implant were age-matched with a cohort of 10 females who previously underwent the GK procedure. Patients in the SK and GK groups underwent implantation of 10 and 6 prostheses, respectively. Muscle tension (Tm), expressed in millinewtons per centimetre squared, mN (cm2)-1, was calculated using the equation Tm = P(ri)(tm)-1, where P is the average maximum squeeze pressure and ri and tm the inner radius and thickness of the external anal sphincter, respectively. The pre- and postimplant changes in Tm and Cleveland Clinic Fecal Incontinence Score (CCFIS) were tested by linear and Poisson regression models, respectively. Results. The CCFIS significantly improved in both groups at 12-month postimplantation. Although not reaching statistical significance, symptom improvement after SK was 33% above that observed after GK (P = .088). Compared to the baseline, a significant increase in Tm was observed in both groups at 12 months (GK, 508.1 [478.8-568.0] vs 864.4 [827.0-885.8] mN (cm2)-1; SK, 528.0 [472.7-564.0] vs 858.6 [828.0-919.6] mN (cm2)-1, P = .005). Compared to the GK group, Tm was significantly higher in patients after SK implant (158.3 mN (cm2)-1 [95% confidence interval, 109.6-207.0]; P < .001), after controlling for baseline values, at 12-month postimplantation. Conclusions. GK and SK are safe and effective treatments for FI with good short-term clinical outcomes. Comparative analysis showed superiority of SK over GK in terms of gain in Tm, with borderline significantly better improvement in symptoms. Larger studies are needed to confirm these findings.

High-resolution Anorectal Manometry Measures Are More Accurate Than Conventional Measures in Detecting Anal Hypocontractility in Women With Fecal Incontinence.

BACKGROUND & AIMS: Anorectal manometry is a common test of anal tone and contractility. However, existing measures are often criticized for their poor ability to detect functional differences between individuals with presumably normal sphincter function and individuals with fecal incontinence. We investigated whether new measures, derived from high-resolution anal manometry (HR-ARM), more accurately identify incontinent women with abnormal sphincter function than measures from conventional anal manometry (C-ARM). METHODS: We performed a prospective HR-ARM study of 85 healthy female volunteers (median age 41 years; range 18-68 years) and 403 women with fecal incontinence (median age 55; range 18-91 years) from June 2013 through December 2015. We compared the diagnostic accuracy of conventional measurements of contractility (C-ARM squeeze increment) and tone (C-ARM resting pressure) (the reference standards), with HR-ARM measures (HR-ARM squeeze increment, HR-ARM contractile integral, HR-ARM resting average, HR-ARM rest integral). We also investigated associations between symptom severity and structural sphincter integrity. RESULTS: We identified anal hypocontractility in 129 women with fecal incontinence using the C-ARM squeeze increment (32% sensitivity; likelihood ratio, 6.4), in 189 women using the HR-ARM squeeze increment (47% sensitivity; likelihood ratio, 9.4), and in 220 women using the HR-ARM contractile integral (55% sensitivity; likelihood ratio, 11.0). In contrast, HR-ARM measures of anal tone did not particularly outperform conventional measures (31% sensitivity for HR-ARM resting average vs 28% for C-ARM resting pressure). Ninety-eight of the 206 patients with fecal incontinence who were classified as having normal anal function, based on C-ARM measures, were reclassified as having abnormal function based on HR-ARM measures. CONCLUSION: In a prospective study of healthy women and women with fecal incontinence, we demonstrated that the newly developed HR-ARM contractile integral increased the sensitivity of detection of anal hypocontractility, from 32% to 55%, compared with conventional measurements of squeeze.

Gatekeeper Improves Voluntary Contractility in Patients With Fecal Incontinence.

BACKGROUND: Gatekeeper (GK) has shown to be safe and effective in patients with fecal incontinence (FI). We aimed to understand its mechanism of action by comparing pre- and post-implant change in the external anal sphincter (EAS) contractility. METHODS: Study of EAS contractility was conducted in 16 FI females (median age = 69 years) before and after implant of 6 GK prostheses. Muscle tension ( Tm), expressed in millinewtons per centimeter squared, mN(cm2)-1, was calculated using the equation Tm = P(ri)(tm)-1, where P is the average maximum squeeze pressure and ri and tm the inner radius and thickness of the EAS, respectively. The effect of a predefined set of covariates on Tm was tested by restricted maximum likelihood models. RESULTS: Compared with baseline, despite unchanged tm (2.7 [2.5-2.8] vs 2.5 [2.2-2.8] mm; P = .31 mm), a significant increase in P (median = 45.8 [26.5-75.8] vs 60.4 [43.1-88.1] mm Hg; P = .017), and ri (12.4 [11.5-13.4] vs 18.7 [17.3-19.6] mm; P < .001) resulted in an increase in Tm (233.2 [123.8-303.2] vs 490.8 [286.9-562.4] mN(cm2)-1; P < .001) at 12 months after GK implant. Twelve-month follow-up improvements were also observed on Cleveland Clinic FI score (8-point median decrease; P = .0001), St Marks FI score (10-point median decrease; P < .0001), and American Medical Systems score (39-point median decrease; P < .0001). Restricted maximum likelihood models showed that years of onset of FI was negatively associated with change in Tm ( P = .048). CONCLUSIONS: GK-related EAS compression positively influences muscle contractility by increasing ri, with consequent increase in Tm (length-tension relationship). Further studies are needed to confirm the long-term effectiveness of GK.