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.

Synchronous "skip" facial metastases from colorectal adenocarcinoma: a case report and review of literature.

BACKGROUND: Skin metastases from colorectal adenocarcinoma are rare conditions that are metachronous in most of cases and may represent the first sign of a recurrence. These lesions are usually located to the abdominal wall on postoperative scars, perineum and chest due to direct spread from the tumor or to the lymphatic and venous dissemination. We describe a rare case of synchronous skin metastases in a patient affected by sigmoid adenocarcinoma with no sign of liver and lung repetitive lesions. CASE PRESENTATION: We admitted a 59 years old male, with no relevant medical history. He was evaluated by our tertiary center of colorectal surgery complaining diarrhoea and abdominal pain. The physical examination revealed a palpable mass in left flank of the abdomen. The colonoscopy showed a sub-stenosis of the sigmoid colon (G2 adenocarcinoma). No repetitive lesions were detected by the preoperative CT scan. The patient reported a rapid grow of a soft supralabial and chin nodules in the last 2 months, which he believed to be related to the use of the mask due to COVID-19 pandemic. A laparoscopic left hemicolectomy with complete mesocolic excision and a local excision of both facial nodules were performed. The histological examination revealed a poorly differentiated signet ring cell colorectal adenocarcinoma with metastases in seven pericolic lymphonodes. The excisional biopsy of the skin nodules revealed a subcutaneous metastases from primary colorectal tumour. CONCLUSIONS: As far as we know, synchronous facial metastases from colorectal cancer in the absence of any other metastases has never been described before. The onset of new skin nodules in patients affected by colorectal cancer should raise-up the clinical suspicion of metastatic lesions even when repetitive lesions are not detected in the liver or lungs.

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.

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.

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.

Chemical signature of colorectal cancer: case-control study for profiling the breath print.

BACKGROUND: Effective screening for colorectal cancer can reduce mortality by early detection of tumours and colonic polyps. An altered pattern of volatile organic compounds (VOCs) in exhaled breath has been proposed as a potential non-invasive diagnostic tool for detection of cancer. The aim of this study was to evaluate the reliability of breath-testing for colorectal cancer screening and early diagnosis using an advanced breath sampler. METHODS: The exhaled breath of patients with colorectal cancer and non-cancer controls with negative findings on colonoscopy was collected using the ReCIVA® Breath Sampler. This portable device is able to capture the alveolar breath fraction without environmental contamination. VOCs were desorbed thermally and analysed by gas chromatography-mass spectrometry. The discriminatory ability of VOCs in detecting colorectal cancer was evaluated by receiver operating characteristic (ROC) curve analysis for each VOC, followed by cross-validation by the leave-one-out method, and by applying stepwise logistic regression analysis. RESULTS: The study included 83 patients with colorectal cancer and 90 non-cancer controls. Fourteen VOCs were found to have significant discriminatory ability in detecting patients with colorectal cancer. The model with the diagnosis of cancer versus no cancer resulted in a statistically significant likelihood of discrimination of 173·45 (P < 0·001), with an area under the ROC curve of 0·979. Cross-validation of the model resulted in a true predictive value for colorectal cancer of 93 per cent overall. Reliability of the breath analysis was maintained irrespective of cancer stage. CONCLUSION: This study demonstrated that analysis of exhaled VOCs can discriminate patients with colorectal cancer from those without. This finding may eventually lead to the creation of a smart online sensory device, capable of providing a binary answer (cancer/no cancer) and directing to further screening.

ANTECEDENTES: Un cribaje efectivo del cáncer colorrectal (colorectal cáncer, CRC) puede reducir la mortalidad mediante la detección precoz de cáncer/pólipos del colon. La identificación de un patrón de compuestos volátiles orgánicos (volatile organic compounds, VOCs) en el aire espirado se ha propuesto como un procedimiento potencial de diagnóstico no invasivo para la detección del cáncer. El objetivo de este estudio fue evaluar la factibilidad del test de la respiración para el cribaje del CRC y diagnóstico precoz empleando un equipo avanzado de muestreo del aliento. MÉTODOS: Se recogieron muestras de aire espirado de 83 pacientes con CRC y de 90 controles sin cáncer con colonoscopia negativa empleando el ReCIVA Breath Sampler©. Este equipo portátil es capaz de capturar la fracción de aire alveolar espirada ausente de contaminación ambiental. Los VOCs fueron aislados térmicamente y analizados mediante cromatografía de gases acoplada a espectrometría de masas. La capacidad discriminatoria de los VOCs para detectar pacientes con CCR se evaluó mediante un análisis de la curva ROC para cada VOC seguida de validación cruzada mediante el método ir eliminando paso a paso cada uno de los VOCs en un modelo de regresión logística. RESULTADOS: Se observó que 14 VOCs tenían habilidad discriminatoria significativa para la detección de pacientes con CRC. El modelo con el diagnóstico de cáncer versus no cáncer mostró una probabilidad estadísticamente significativa de 151,03 (P < 0,0001) con un área bajo la curva (area under the curve, AUC) de 0,963. En la validación cruzada del modelo se obtuvo un valor global predictivo verdadero para el CRC del 92,5%. La fiabilidad del análisis del aire espirado se mantuvo con independencia del estadio del cáncer. CONCLUSIÓN: Este estudio ha demostrado que el análisis de los VOCs en el aire espirado puede discriminar pacientes con CRC de pacientes sin cáncer. Este hallazgo podría ser de ayuda para diceñar un dispositivo sensorial inteligente en línea, capaz de proporcionar una respuesta binaria (cáncer/NO cáncer) y asimismo contribuir a la indicación de una futura colonoscopia.

European Society of ColoProctology: guideline for haemorrhoidal disease.

AIM: The goal of this European Society of ColoProctology project was to establish a multidisciplinary, international guideline for haemorrhoidal disease (HD) and to provide guidance on the most effective (surgical) treatment for patients with HD. METHODS: The development process consisted of six phases. In phase one we defined the scope of the guideline. The patient population included patients with all stages of haemorrhoids. The target group for the guideline was all practitioners treating patients with haemorrhoids and, in addition, healthcare workers and patients who desired information regarding the treatment management of HD. The guideline needed to address both the diagnosis of and the therapeutic modalities for HD. Phase two consisted of the compilation of the guideline development group (GDG). All clinical members needed to have affinity with the diagnosis and treatment of haemorrhoids. Further, attention was paid to the geographical distribution of the clinicians. Each GDG member identified at least one patient in their country who could read English to comment on the draft guideline. In phase three review questions were formulated, using a reversed process, starting with possible recommendations based on the GDG's knowledge. In phase four a literature search was performed in MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews. The search was focused on existing systematic reviews addressing each review question, supplemented by other studies published after the time frame covered by the systematic reviews. In phase five data of the included papers were extracted by the surgical resident (RT) and checked by the methodologist (JK) and the GDG. If needed, meta-analysis of the systematic reviews was updated by the surgical resident and the methodologist using Review Manager. During phase six the GDG members decided what recommendations could be made based on the evidence found in the literature using GRADE. RESULTS: There were six sections: (i) symptoms, diagnosis and classification; (ii) basic treatment; (iii) outpatient procedures; (iv) surgical interventions; (v) special situations; (vi) other surgical techniques. Thirty-four recommendations were formulated. CONCLUSION: This international, multidisciplinary guideline provides an up to date and evidence based summary of the current knowledge of the management of HD and may serve as a useful guide for patients and clinicians.

The management of esophago-gastric necrosis due to caustics ingestion: Anastomotic reinforcement with Cyanoacrylate glue and damage control with Vacuum Assisted Closure Therapy-A case report.

INTRODUCTION: The surgical treatment of a complete gastric necrosis due to caustic ingestion is extremely challenging and life threatening. In this emergency scenario, a first-time reconstruction of the gastrointestinal tract is often dangerous for the patient because of the high risk of infections and anastomosis leakage. Literature lacks of clear indications for the management of this condition. PRESENTATION OF CASE: Male patient with history of major depression disorder was admitted to our Emergency Unit after the ingestion of muriatic acid. CT scan showed massive pneumo-peritoneum with esophago-gastric thickening. Free fluids in the abdominal cavity were detected. Intraoperative finding was a complete necrosis of the stomach and corrosion of the lower esophagus. DISCUSSION: In this case report we proposed a first approach with the drainage and lavage of the abdomen cavity. Then, an esophago-jejunum anastomosis reinforced by Cyanoacrylate glue was performed and a damage control with VAC therapy (Vacuum Assisted Closure) was carried out. CONCLUSION: Cyanoacrylate glue could be considered useful and efficient in the reinforcement of anastomosis even in emergency surgical procedures. Damage control using VAC allows to keep a good control of the surgery performed.

Post-operative clinical, manometric, and defecographic findings in patients undergoing unsuccessful STARR operation for obstructed defecation.

AIM: To evaluate the reason for failure of STARR (stapled transanal rectal resection) operation for obstructed defecation. METHODS: A retrospective study (June 2012-December 2017) was performed using a prospectively maintained database of patients who underwent STARR operation for ODS (obstructed defecation syndrome), complaining of persisting or de novo occurrence of pelvic floor dysfunctions. Postoperative St Mark's and ODS scores were evaluated. A VAS was used to score pelvic pain. Patients' satisfaction was estimated administering the CPGAS (clinical patient grading assessment scale) questionnaire. Objective evaluation was performed by dynamic proctography and anorectal manometry. RESULTS: Ninety patients (83.3% females) operated for ODS using STARR technique were evaluated. Median ODS score was 19 while 20 patients (22%) reported de novo fecal urgency and 4 patients a worsening of their preoperative fecal incontinence. Dynamic proctography performed in 54/90 patients showed a significant (> 3.0 cm) rectocele in 19 patients, recto-rectal intussusception in 10 patients incomplete emptying in 24 patients. When compared with internal normal standards, anorectal manometry showed decreased rectal compliance and maximum tolerable volume in patients with urgency. Nine patients reported a persistent postoperative pelvic pain (median VAS score 6). CONCLUSION: Failure of STARR to treat ODS, documented by persisting ODS symptoms, fecal urgency, or chronic pelvic pain, is often justified by the persistence or de novo onset of alteration of the anorectal anatomy at defecation. This occurs in about half of the patients, but in 40% of the cases who complained of incomplete emptying or incontinence, anatomical abnormalities were not recognized.

Pelvic floor rehabilitation for defecation disorders.

Pelvic floor rehabilitation is frequently recommended for defecation disorders, in both constipation and fecal incontinence. However, the lack of patient selection, together with the variety of rehabilitation methods and protocols, often jeopardize the results of this approach, causing difficulty in evaluating outcomes and addressing proper management, and above all, in obtaining scientific evidence for the efficacy of these methods for specific indications. The authors represent different gastroenterological and surgical scientific societies in Italy, and their aim was to identify the indications and agree on treatment protocols for pelvic floor rehabilitation of patients with defecation disorders. This was achieved by means of a modified Delphi method, utilizing a working team (10 members) which developed the statements and a consensus group (15 members, different from the previous ones) which voted twice also suggesting modifications of the statements.

Surgical management of haemorrhoids: an Italian survey of over 32 000 patients over 17 years.

AIM: The management of haemorrhoids has changed significantly in the last two decades as a result of new insights into their pathophysiology and the availability of new surgical devices. The aim of this survey was to evaluate changes in the management of haemorrhoids in Italy over the last 17 years. METHOD: An electronic database which recorded details of management relating to the severity of haemorrhoids between 2000 and 2016 was obtained from 18 of 34 colorectal surgeons who were invited to participate. RESULTS: A total of 32 458 patients were treated for haemorrhoids by 18 expert coloproctologists during a 17-year period. Patients were classified as Grade II (7542, 23.2%), Grade III(15 360, 47.3%) and Grade IV (9556, 29.4%). Grade II haemorrhoids were treated with rubber band ligation in over 90% of the cases, and patients with Grade IV had a Milligan-Morgan (MM) haemorrhoidectomy in over 90% of the cases. In Grade III, the use of stapled haemorrhoidopexy progressively decreased from 30% to 35% (between 2000 and 2007) to 5% of the cases. Meanwhile, commencing from 2006 the use of Doppler-guided haemorrhoid artery ligation (DGHAL) with mucopexy increased progressively from 6% to 24%. Over the years, the percentage of MM haemorrhoidectomy remained consistent at between 65% and 70% of the cases. CONCLUSION: Relevant changes in the surgical choice of haemorrhoid treatment have occurred in Italy over the last 17 years. MM haemorrhoidectomy remains the most frequently performed procedure for Grade III haemorrhoids. Stapled haemorrhoidopexy has become much less popular in contrast to DGHAL with mucopexy which is being performed much more frequently.