The optimal management strategy for grade III hemorrhoids remains a subject of ongoing debate. Hemorrhoidectomy is the criterion standard, but rubber band ligation offers a less invasive outpatient alternative. Treatment variability persists due to a lack of consensus on the preferred strategy.

To directly compare the effectiveness of rubber band ligation and hemorrhoidectomy in the treatment of grade III hemorrhoids.

Open-label, parallel-group, randomized controlled noninferiority trial.

Multicenter study across 10 Dutch hospitals from October 2019 to September 2022.

Patients (aged 18 years or older) with symptomatic grade III (Goligher) hemorrhoids were included in this study. Exclusion criteria included prior rectal/anal surgery, more than 1 rubber band ligation/injection within the preceding 3 years, rectal radiation, preexisting sphincter injury, IBD, medical unfitness for surgery (ASA higher than 3), pregnancy, or hypercoagulability disorders.

Randomized 1:1 to rubber band ligation or hemorrhoidectomy, with up to 2 banding sessions allowed.

Primary outcomes included 12-month health-related quality of life and recurrence rate. Secondary outcomes included complications, pain, work resumption, and patient-reported outcome measures.

Eighty-seven patients were randomly assigned (47 rubber band ligation vs 40 hemorrhoidectomy). Rubber band ligation was not noninferior to hemorrhoidectomy in quality-adjusted life years (-0.045; 95% CI, -0.087 to -0.004). Recurrence rate was worse in the rubber band ligation group (47.5% vs 6.1%), with an absolute risk difference of 41% (95% CI, 24%-59%). Complication rates were comparable. Pain scores after hemorrhoidectomy were higher during the first week (visual analogue scale 4 vs 1; p = 0.002). Rubber band ligation group returned to work sooner (1 vs 9 days; p = 0.021). Patient-reported hemorrhoidal symptom scores favored hemorrhoidectomy.

The primary limitation of the study was its early termination due to funding constraints, resulting in a relatively small sample size and limited statistical power. Patient recruitment was hindered by significant treatment preferences and the COVID-19 pandemic.

Hemorrhoidectomy may benefit patients with grade III hemorrhoids in terms of quality of life, recurrence risk, and symptom burden, whereas rubber band ligation allows faster recovery with less pain. These findings can guide clinical decision-making. See Video Abstract .

NCT04621695.

ANTECEDENTES:La estrategia óptima de tratamiento para las hemorroides grado III sigue siendo un tema de debate continuo. La hemorroidectomía es el estándar de oro, pero la ligadura con banda elástica ofrece una alternativa ambulatoria menos invasiva. La variabilidad del tratamiento persiste debido a la falta de consenso sobre la estrategia preferida.OBJETIVO:Comparar directamente la eficacia de la ligadura con banda elástica y la hemorroidectomía en el tratamiento de las hemorroides grado III.DISEÑO:Ensayo de no inferioridad, controlado, aleatorizado, de grupos paralelos y abierto.ENTORNO CLINICO:Estudio multicéntrico en 10 hospitales holandeses desde octubre de 2019 hasta septiembre de 2022.PACIENTES:Pacientes (≥18 años) con hemorroides sintomáticas grado III (Goligher). Exclusiones: cirugía rectal/anal previa, >1 ligadura con banda elástica/inyección en los tres años anteriores, radiación rectal, lesión preexistente del esfínter, enfermedad inflamatoria intestinal, incapacidad médica para la cirugía (ASA >3), embarazo o trastornos de hipercoagulabilidad.INTERVENCIONES:Aleatorización 1:1 para ligadura con banda elástica o hemorroidectomía, con hasta dos sesiones de ligadura permitidas.PRINCIPALES MEDIDAS DE RESULTADOS:Primarias: calidad de vida relacionada con la salud a los 12 meses y tasa de recurrencia. Secundarias: complicaciones, dolor, reanudación del trabajo y medidas de resultados informadas por el paciente.RESULTADOS:Se aleatorizaron ochenta y siete pacientes (47 ligadura con banda elástica frente a 40 hemorroidectomía). La ligadura con banda elástica no fue no inferior a la hemorroidectomía en años de vida ajustados por calidad (-0,045, intervalo de confianza del 95 %: -0,087 a -0,004). La tasa de recurrencia fue peor en el grupo de ligadura con banda elástica (47,5 % frente a 6,1 %), con una diferencia de riesgo absoluto del 41 % (intervalo de confianza del 95 %: 24 %-59 %). Las tasas de complicaciones fueron comparables. Las puntuaciones de dolor posthemorroidectomía fueron más altas durante la primera semana (escala analógica visual 4 frente a 1; p = 0,002). El grupo de ligadura con banda elástica volvió al trabajo antes (1 frente a 9 días; p = 0,021). Las puntuaciones de síntomas hemorroidales notificadas por los pacientes favorecieron a la hemorroidectomía.LIMITACIONES:La principal limitación del estudio fue su finalización temprana debido a las limitaciones de financiación, lo que dio lugar a un tamaño de muestra relativamente pequeño y a un poder estadístico limitado. El reclutamiento de pacientes se vio obstaculizado por las preferencias significativas de tratamiento y la pandemia de COVID-19.CONCLUSIONES:La hemorroidectomía puede beneficiar a los pacientes con hemorroides de grado III en términos de calidad de vida, riesgo de recurrencia y carga de síntomas, mientras que la ligadura con banda elástica permite una recuperación más rápida con menos dolor. Estos hallazgos pueden orientar la toma de decisiones clínicas. (Traducción- Dr. Francisco M. Abarca-Rendon )NÚMERO DE REGISTRO DEL ENSAYO CLÍNICO:NCT04621695.

Hemorrhoidal disease (HD) is associated with substantial economic burden and negative effects on health-related quality of life (HRQoL). The aCute HaemORrhoids treatment with MESoglycan (CHORMES) study aims to evaluate the effects of orally administered mesoglycan, a natural preparation of glycosaminoglycans with antithrombotic and profibrinolytic properties, as an acute treatment in patients with HD.

CHORMES is a phase 2, double-blind, randomized controlled trial being conducted at two centers in Italy. Adults aged 18-75 years with Grade I-III HD according to Goligher classification or external thrombosed hemorrhoids, and a Hemorrhoidal Disease Symptom Score (HDSS) of ≥ 5, will be randomly allocated in a 1:1 ratio to mesoglycan or placebo and will be treated for 40 days (two capsules for the first 5 days and one capsule for the subsequent 35 days twice daily [after breakfast and dinner], equivalent to 200 mg in the first 5 days and 100 mg subsequently). Concomitant use of analgesics is permitted in both treatment groups. The trial aims to enroll 50 patients, with 25 patients in each treatment group. The primary objective of the trial is to evaluate the efficacy of mesoglycan in reducing symptoms of HD, assessed via change in HDSS from baseline (day 0) to day 40 in the intention-to-treat population. Secondary objectives include changes in HRQoL from baseline to day 40 using the Short Health Scale for Hemorrhoidal Disease, safety (adverse effects, physical assessments, vital signs and laboratory parameters in the safety population), fecal continence assessed using the Vaizey score, bleeding assessed using the Bleeding score, the amount and type of analgesic taken, and pain. Patient enrolment began on 11 December 2023, and trial completion is expected by December 2024.

The CHORMES trial will evaluate the efficacy and safety of mesoglycan, in addition to its impact on HRQoL, analgesic use and pain, in patients with HD. The results of the trial will assist clinicians in determining the most effective treatment for patients with HD.

ClinicalTrials.gov NCT06101992. Prospectively registered on 26 October 2023 at https://clinicaltrials.gov/ct2/show/NCT06101992 .

Endoscopic rubber band ligation (ERBL) is a nonsurgical technique for the treatment of symptomatic internal hemorrhoids but is limited by recurrence and post-procedural pain.

To evaluate satisfaction, long-term recurrence, and post-procedural pain in managing internal hemorrhoids using a combination of polidocanol foam sclerotherapy and ERBL.

This was a prospective, multicenter, randomized study. A total of 195 consecutive patients diagnosed with grade II-III internal hemorrhoids were enrolled from four tertiary hospitals and randomly divided into a cap-assisted endoscopic polidocanol foam sclerobanding (EFSB) or an ERBL group. All patients were followed-up for 12 months. Symptom-based severity and post-procedural pain were assessed using a hemorrhoid severity score (HSS) and a visual analog scale (VAS). Continuous variables were reported as medians and interquartile range.

One hundred and ninety-five patients were enrolled, with 98 in the EFSB group. HSS was lower in the EFSB group than in the ERBL group at 8 weeks [4.0 (3.0-5.0) vs 5.0 (4.0-6.0), P = 0.003] and 12-month [2.0 (1.0-3.0) vs 3.0 (2.0-3.0), P < 0.001] of follow-up. The prolapse recurrence rate was lower in the EFSB group at 12 months (11.2% vs 21.6%, P = 0.038). Multiple linear regression analysis demonstrated that EFSB treatment [B = -0.915, 95% confidence interval (CI): -1.301 to -0.530, P = 0.001] and rubber band number (B = 0.843, 95%CI: 0.595-1.092, P < 0.001) were negatively and independently associated with the VAS score 24 hours post-procedure. The median VAS was lower in the EFSB group than in the ERBL [2.0 (1.0-3.0) vs 3.0 (2.0-4.0), P < 0.001].

Cap-assisted EFSB provided long-term satisfaction and effective relief from the recurrence of prolapse and pain 24 hours post-procedure.

Hemorrhoidal disease, which affects nearly 40% of people, is characterized by pathological alterations and distal displacement of hemorrhoidal tissue. The short health scale (SHSHD) and the hemorrhoidal disease symptom score (HDSS) are two tools that can be utilized to assess the quality of life of hemorrhoidal patients. The present study aims to translate, modify, and validate the HDSS and SHSHD questionnaires in Indonesian.

This cross-sectional study assessed the validity and reliability of the HDSS and SHSHD Indonesian adaptation instrument in hemorrhoidal patients from April 15, 2022, and April 1, 2023.

There were 91 study subjects, 55 males and 36 females. The study showed that the subscale interpretations of the R-values and the full scale scored above 0.25, indicating weak to very strong correlations. These results mean that the HDSS and SHSHD questionnaires are valid for use. Based on the study's results, the R-value of each item, domain, and total score ≥0.8 (p <0.05) indicates that the HDSS and SHSHD instruments are reliable.

The Indonesian adaptation of the HDSS and SHSHD demonstrates validity and reliability as an assessment tool for measuring the healthrelated quality of life in Indonesian patients diagnosed with hemorrhoidal disease.

As a common benign anal condition, the high incidence and recurrence of hemorrhoids pose challenges for both patients and doctors. The classification of hemorrhoids plays a crucial role in assessing, diagnosing, and treating the condition. By using appropriate classification and corresponding treatment strategies, we can achieve higher cure rates and lower recurrence rates of hemorrhoids. Since the introduction of the Miles classification in 1919, various classifications have been developed, which include objective classifications based on anatomical or instrumental assessment and subjective classifications based on symptoms and patient sensations. These classifications aim to accurately evaluate the condition. In this study, we discuss the evaluation values of each classification in terms of their advantages, disadvantages, treatment relevance, reproducibility, practicality, and assessment value. We also analyze the significant and essential factors, principles of use, and components of assessment indicators of hemorrhoidal classification. This study proposes several strategies to address the limitations of current hemorrhoidal assessment methods. All these will provide a reference for the development regarding the assessment and classification of hemorrhoids and clinical diagnosis and management of hemorrhoids.

The aim of this study was to translate the Dutch patient-reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS) to English and perform a cross-cultural validation.

The ISPOR good practice guidelines for the cross-cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM-HISS.

Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM-HISS was reached. Interviews were conducted with 10 native English-speaking HD patients (30% female), with a mean age of 44 years (24-83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM-HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics.

The translated English language PROM-HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment.

The main objective of this study was to assess the impact on quality of life after rubber band ligation (RBL) in patients with symptomatic grade II-III haemorrhoids who did not improve after 6 months of conservative treatment, using quality of life scores.

This was a prospective cohort observational study where patients with haemorrhoidal disease and indication for RBL were included between December 2019 and December 2020. RBL was offered as first-line treatment in this group. Patient´s quality of life was assessed by scores: HDSS (Hemorrhoidal Disease Symptom Score) and SHS (Short Health Scale).Secondary objectives were: to evaluate the rate of patients requiring one or more RBL procedures, to establish the overall success rate of RBL and to analyse complications.

A total of 100 patients were finally included. Regarding the impact on quality of life after RBL, a significant reduction was found in the HDSS and SHS scores (p < 0.001). The main improvement was found in the first month and it was maintained until the sixth month. A high degree of satisfaction with the procedure was reported by 76% of patients. The overall success rate of banding was 89%. A 12% complication rate was detected, the most frequent complication was severe anal pain (58.3%) and self-limiting bleeding (41.7%).

Rubber band ligation, as a treatment for symptomatic grade II-III haemorrhoids that do not respond to medical treatment, leads to a significant improvement in patients' symptoms and quality of life. It also has a high degree of satisfaction between patients.

The Hemorrhoidal Disease Symptom Score (HDSS) is a tool that is scored based on five main symptoms: pain, bleeding, itching, soiling, and prolapse. Furthermore, the Short Health Scale (SHS) is a measurement tool of subjective health and health-related quality of life. This study was performed to validate the Farsi-translated Hemorrhoidal Disease Symptom Score (HDSS), and Scale Short Health Scale adapted for hemorrhoidal disease (SHS-HD) as a measure of symptom severity in patients with hemorrhoid disease.

In this study, HDSS and SHS-HD were translated into Farsi. Participants with confirmed hemorrhoid disease completed the questionnaire. Subsequently, the questionnaire's discriminative validity, convergent validity, reliability, sensitivity, and specificity were evaluated.

Data from 31 patients were analyzed (mean age 39.68; 71% male). The results of the analysis showed good internal consistency as Cronbach's α for HDSS and SHS were 0.994 and 0.995 respectively. Spearman's correlation coefficient for the test-retest comparison was 0.986 (p < 0.01). The responses demonstrated good convergent validity. Moreover, the comprehension and suitability of each question were rated as excellent (Pearson's correlation coefficient = 0.3).

Our findings revealed that the Farsi translation of the HDSS and SHS-HD can be a valuable tool for evaluating the symptom severity in patients with hemorrhoid disease.

Haemorrhoids are a very common disease and many professional societies have produced guidelines for their treatment. The aim of this study is to appraise the quality of the existing guidelines in the management of haemorrhoids.

A systematic search of the literature was conducted in the EMBASE, Google Scholar, Cochrane library, and PubMed databases. The quality of guidelines was independently appraised using the Appraisal of Guidelines Research and Evaluation II (AGREE II) instrument by five of the authors.

Six guidelines of varying quality were identified and included in this study. The highest scoring guidelines were the SICCR (Società Italiana di Chirurgia Colorectale, which is Italian Society of Colorectal Surgery), ESCP (European Society of Coloproctology) and ASCRS (American Society of Colon and Rectal Surgeons) guidelines, scoring 86% each overall. There was considerable variability across not just the studies but across the different domains. The highest scoring domains were domain VI: editorial independence (median =95% across all studies) and domain I: Scope & Purpose (85%). The lowest scores were observed in domain V: Applicability (48%) and domain II: Stakeholder Involvement (41%). Only three of the six gained unanimous support for their use, whilst two of the guidelines were unanimously declared not suitable for clinical use.

With the notable exception of three guidelines (SICCR, ESCP and ASCRS), the general quality of haemorrhoid guidelines is poor. Stakeholder (especially patient) involvement and instructions on how to implement recommendations is lacking from the majority of guidelines. This is an area that requires urgent attention if we are to improve guidelines in haemorrhoid management.

Haemorrhoidal disease (HD) is a common condition that often requires surgical treatment. In comparison with other traditional techniques, radiofrequency thermocoagulation (RFTC) has multiple advantages to traditional repairs and can be a good alternative in surgical management of HD. We retrospectively analysed 20 patients with Grades 2 (n = 6, 30%) and 3 (n = 12, 70%) haemorrhoids undergoing RFTC from 1 September 2019 to 31 December 2021. Outcomes including post-operative (PO) pain, immediate/late PO complications, recurrence and patient satisfaction were assessed. Twenty cases were included in this case series. All pathological symptoms showed significant improvement in PO period. Eight complications were noted, including minor bleeding (n = 2), bleeding that required admissions (n = 3), pain (n = 2) and recurrence (n = 1). The mean time off work is 7 days and all patients were satisfied or very satisfied PO as per telephone questionnaire. RFTC is a safe and effective solution in the management of HD and is a good alternative to conventional procedures.

The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids.

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.

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.

Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

Haemorrhoidal disease (HD) is a frequently occurring disorder with a significant negative impact on a patient's quality of life. Here, we describe the development and validation of the Dutch patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS).

The development of the PROM-HISS followed recommended guidelines. Face and content validity, structural properties, reliability and construct validity were evaluated in a HD population. Reliability was tested by assessing the test-retest reliability, defined by the intraclass correlation coefficient (ICC), and internal consistency measured with Cronbach's alpha. Construct validity was evaluated using confirmatory factor analysis (CFA) and hypotheses testing.

The PROM-HISS consists of three domains: (1) HD symptoms (blood loss; pain; prolapse; soiling; itching), (2) impact of symptoms on daily activities, and (3) satisfaction with treatment. The PROM-HISS showed good face and content validity. The PROM-HISS was completed by 102 patients (65% male), with a mean age of 58 years (23-81 years). The ICCs of the different items in the domain HD symptoms ranged between 0.56 and 0.79 and were interpreted as good. The Cronbach's alpha value was 0.80 and considered satisfactory. The CFA provided further evidence for construct validity with a good model fit. A high score on the symptoms of HD correlated with a high impact of HD on daily activities (Pearson's r = 0.632, p < 0.01) and a low degree of satisfaction (Pearson's r = 0.378, p < 0.01).

The PROM-HISS is a reliable and valid instrument to evaluate symptoms of HD, impact on daily activities and satisfaction with treatment.

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.

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.

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.

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.

Hemorrhoidal disease (HD) is defined as the symptomatic enlargement and/or distal displacement of anal cushions and is one of the most common proctological diseases. Sclerotherapy (ST) with 3% polidocanol foam induces an inflammatory reaction with sclerosis of the submucosal tissue and consequent suspension of the hemorrhoidal tissue. The aim of this study was to evaluate the short-term effectiveness and safety of ST with 3% polidocanol foam for the treatment of symptomatic second- and third-degree HD.

A total of 66 patients with symptomatic second- and third-degree HD underwent a single ST session between March 2017 and July 2018. A visual analog scale score was used to assess post-operative pain and patient satisfaction. The symptoms severity and anal continence were investigated through the Hemorrhoid Severity Score (HSS) and Vaizey score, respectively, at baseline, at 4 weeks and after 1 year.

Fifty-seven out of 66 patients were male (86.3%), and the mean age was 52 (29-75; SD ± 12) years. The mean operative time was 4.5 (2-6; SD ± 1.23) minutes. No intraoperative complications and no drug-related side effects occurred. The overall success rate was 78.8% (52/66 patients) after a single ST session and 86% after two ST sessions (57/66 patients). The mean treatment effect, obtained comparing preoperative and 12 months symptom scores in each patient, showed a median change of 8 (p < 0.001). All patients resumed their normal daily activities the day after the procedures.

ST with 3% polidocanol foam is a safe, cost-effective and repeatable conservative treatment.

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.

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.

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.

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.

Haemorrhoidal disease can severely affect a patient's quality of life. Its classification is commonly based on morphology of the degree of prolapse; however, this does not take into account the symptoms and impact on the quality of life. The aim of this systematic review was to determine the most appropriate instruments that classify the severity of disease according to symptoms.

A PRISMA-compliant search was conducted in December 2019 to identify studies that described the validation of a haemorrhoidal symptom score. The measurement properties of the scoring systems were assessed based on the consensus-based standards for the selection of health status measurement instruments (COSMIN) methodology for systematic reviews for patient-reported outcome measures.

A total of 5288 articles were identified, with five articles included. Three studies developed a scoring system based on a set of core symptoms for a cohort of patients and validated the score against treatment outcomes. One study developed a disease-specific quality of life questionnaire based on symptoms to evaluate disease burden. One study combined both quality of life and symptom measures and tested measurement properties on two cohorts of patients. Only one study demonstrated satisfactory valid, reliable and responsive measurement criteria.

A single study demonstrated sufficient quality in measurement properties to be recommended for clinical use. Further studies in this area should utilize consensus-based standards for designing and reporting validation research to ensure that the appropriate evidence base is acquired if any further patient-reported outcome measures are to be recommended.

The Sodergren score was developed to objectively measure the severity of haemorrhoidal symptoms. This study aimed to determine if there was a difference in the Sodergren score between patients who were offered surgery and patients who underwent successful rubber band ligation of internal haemorrhoidal disease and to assess its performance in guiding management.

This is a prospective, observational study. The preintervention Sodergren scores of subjects with internal haemorrhoidal disease were recorded and blinded to the surgeon in charge. Sodergren scores of subjects in the two arms were unblinded and compared at the end of the study.

The results for 290 patients were available for final analysis. The median scores of those offered surgery and those who underwent successful rubber band ligation differed significantly [4 (interquartile range 3-10) vs 0 (interquartile range 0-4), P = 0.001]. In predicting treatment, the Sodergren score had an area under the receiver operating characteristic curve of 0.735 (95% CI 0.675-0.795).

There is a significant difference in scores between patients who were offered surgery and patients with successful rubber band ligation. Our study suggests that the Sodergren score has an acceptable discrimination in predicting the need for surgery in internal haemorrhoidal disease. We propose that patients with a Sodergren score of 6 or more be considered for upfront surgery. This score could potentially be used to standardize outcomes of future haemorrhoid trials.

The aim of this work was to perform a long-term evaluation of a randomized trial focusing on functional aspects after excisional haemorrhoidectomy with a minimum follow-up of 9 years.

A questionnaire-based study including patients operated on for haemorrhoids in Sweden between 1999 and 2003. A total of 225 patients were randomized to Milligan's or Ferguson's operation. Twenty-six patients had died and 151 (76%) participated after a median follow-up of 10.7 years (range 9.2-12.6 years).

Seventy-seven patients were in the Milligan group and 74 in the Ferguson group. Forty-eight (32%) reported recurrence. Anal bleeding was reported in 80% at baseline but in 28% at long-term follow-up (P < 0.0001). At baseline, 49% had spontaneous anal pain and 25% pain at defaecation. At follow-up, these figures were 17% and 11%. At follow-up, 19% described a sense of anal stenosis. At baseline, soiling was reported in 51% but in 20% at long-term follow-up (P < 0.001). Nineteen per cent used pads preoperatively and 6% at follow-up (P < 0.0001). Straining at defaecation was reported by 35% at baseline. At follow-up, this figure was 25% (P = 0.055).

Symptoms associated with haemorrhoids were reduced at long-term follow-up. The most common problems were perceived recurrence and a sense of anal stenosis.

Hemorrhoidal disease is the most common proctologic disease and the search for new treatment methods, as well as an in-depth understanding of the mechanisms underlying effects of well-known agents on disease pathogenesis still remain relevant. There have been long recognized the effects of the E.coli bacterial culture suspension (BCS) as a therapeutic means eliciting decreased exudation during inflammation, wound healing, tissue regeneration, and stimulated immunity. Here, based on recent findings related to innate and adaptive immune cells, we set out to present mechanisms accounting for some effects coupled to commensal bacteria, particularly inactivated E.coli BCS, which are important for understanding pathogenesis-related action of drug Posterisan and Posterisan forte, and outline their broad application in therapy of hemorrhoids. Based on the analysis, it was concluded that such effects are mediated via multi-pronged and complementary interactions between diverse human receptors expressed in the anorectal region cells and microbial components: NOD ligands, metabolites, enzymes, heat shock proteins and nucleic acids, which lead to production of pro-inflammatory cytokines by anodermal colonocytes, innate and adaptive immune cells, neurons in the submucosal plexus covered by transitional zone epithelium, and hemorrhoid plexus endothelium. Based on current concepts, it may be plausible that E.coli BCS-derived biologically active components contained in drug Posterisan are capable of exerting both positive local and systemic effects, which extend our understanding and substantiate its use in hemorrhoidal disease. The effectiveness of using Posterisan and Posterisan forte is corroborated by their indications in real-life clinical practice, both as a conservative therapy as well as after surgical interventions.

The comparison between haemorrhoidal treatments is still unclear. Attempts have been made to adopt a unifying postoperative scoring system and thus ensure adequate comparison between clinical trials. We aimed to systematically review the available outcome scores of haemorrhoidal treatment.

MEDLINE/Pubmed, Web of science, Embase and Cochrane were searched from database implementation until the December 6th 2019. All studies describing or referencing a score to assess haemorrhoidal disease treatment were included. Likert scale alone, incontinence score alone, general assessment of quality of life or scores developed for other proctologic disorders were excluded. The main outcome measures were validation of the scores and correlation of the score items to the core outcome set for haemorrhoidal disease developed by the European Society of Coloproctology.

From the 633 records initially screened, 22 studies were included: 8 original articles describing a scoring system and 14 referencing a previously described scoring system. Only 1 score was validated by an external prospective cohort. All the scores evaluated the symptoms of haemorrhoidal disease. No score integrated the disease recurrences or patient's satisfaction. Scores values tended to decrease postoperatively.

The scores described by Gerjy et al. and by Shanmugan et al. are available questionnaires, which have been validated and used in various studies. These scores might help researchers for comparative studies between treatment modalities and optimize haemorrhoids treatment.

Hemorrhoidal disease (HD) is the most common proctological disease in the Western countries. However, its real prevalence is underestimated due to the frequent self-medication.The aim of this consensus statement is to provide evidence-based data to allow an individualized and appropriate management and treatment of HD. The strategy used to search for evidence was based on application of electronic sources such as MEDLINE, PubMed, Cochrane Review Library, CINAHL, and EMBASE.These guidelines are inclusive and not prescriptive.The recommendations were defined and graded based on the current levels of evidence and in accordance with the criteria adopted by American College of Chest Physicians. The recommendations were graded A, B, and C.

Haemorrhoidal disease (HD) is a common colorectal condition that often requires surgical treatment. Less invasive procedures are usually more acceptable to patients. The aim of this study was to report the outcome of a novel and minimally invasive technique employing a radiofrequency ablation (RFA) energy (Rafaelo^®) to treat HD.

A total number of 27 patients who had RFA for the treatment of HD were recruited to this study. The procedure was performed under deep sedation and local anaesthesia. Patients' demographics; haemorrhoid severity score (HSS); quality of life; pain and satisfaction scores; and recurrence rate were recorded.

The mean age of the patients was 46 (SD 14) years, 18 (67%) males and 9 (33%) females. The mean body mass index was 25 (SD 4) kg/m². The predominant symptom of all patients was per-rectal bleeding. HSS improved from 7.2 (SD 1.9) before the procedure to 1.6 (SD 1) after the procedure (p < 0.0001). Postoperative pain scores on a scale of 0-10 were 0, 2 (SD 2), 1 (SD 2), and 0 on immediate, day-1, day-3, and 2-month follow-up questionnaire. The mean satisfacion score was 9 (SD 1.5) out of 10 on 2-month follow-up. Mean time until patients returned to normal daily activity was 3 (SD 1) days following the procedure. Quality-of-life assessments including: visual analogue scale scores (before: mean 70, SD 23; after: mean 82, SD 16; p < 0.001) and EQ-5D-5L (before: mean 0.84, SD 0.15; after: mean 0.94, SD 0.13; p < 0.05) were significantly improved. The mean length of follow-up for recurrence of symptoms was 20 months (range 12-32 months). One patient (4%) reported the recurrence of rectal bleeding 12 months after the procedure.

RFA for the treatment of HD is safe and effective in achieving symptomatic relief. It is associated with minimal postoperative pain and low incidence of recurrence.