Rectal Bleeding in Infants: Diagnostic Work-up and Management.

Lower gastrointestinal bleeding is an alarming symptom in pediatrics, especially in infancy. However, it is commonly secondary to benign and self-limiting conditions, such as anal fissures, infections, and allergies; more rarely it is caused by more serious disorders, such as necrotizing enterocolitis, very early onset inflammatory bowel diseases, and vascular malformations. The present review aims at summarizing the different clinical conditions presenting with rectal bleeding in infancy and provides an evidence-based diagnostic work-up for the clinical management of patients with this occurrence.

Associations between functional constipation and non-IgE-mediated food allergy in infants and children.

BACKGROUND: The non-IgE-mediated food allergy (non-IgE-FA) is less prevalent than IgE-mediated food allergy, and their relationship with functional constipation (FC) needs to be clarified. METHODS: A total of 305 infants and children with constipation treated in the Department of Pediatric Gastroenterology, Children's Hospital of Nanjing Medical University, from July 2020 to December 2021 were included in this study. Four cases with organic lesions were excluded. Among 301 diagnosed with FC, according to ROME IV criteria, 81 cases with allergy-related indicators were further evaluated for food allergy by food-specific IgG antibody test, allergen- specific IgE antibody detection, skin prick test, and food avoidance and reintroduction. RESULTS: A total of 45 cases with FC were diagnosed with food allergy, and the incidence rate was 15%. Among the 45 patients, 35 cases (77.8%) had FC with non-IgE-FA. The main clinical symptoms or signs included anal fissure, abdominal pain, and pain during defecation. The most prevalent allergic foods were cow's milk, eggs, fish, and shrimp. Ten (22.2%) cases reported FC with mixed food allergy, including both non-IgE-mediated and IgE-mediated food allergy. This study focused on non-IgE-mediated food allergy-related FC. CONCLUSION: Our results showed that the incidence of food allergy in infants and children with FC was 15%, which was mainly mediated by non-IgE-FA. The main clinical symptoms or signs in these cases included anal fissure, abdominal pain, and pain during defecation, and the main allergens included milk, eggs, fish, and shrimp.

Natural History of Anal Ulcerations in Pediatric-Onset Crohn's Disease: Long-Term Follow-Up of a Population-Based Study.

INTRODUCTION: Anal ulcerations are frequently observed in Crohn's disease (CD). However, their natural history remains poorly known, especially in pediatric-onset CD. METHODS: All patients with a diagnosis of CD before the age of 17 years between 1988 and 2011 within the population-based registry EPIMAD were followed retrospectively until 2013. At diagnosis and during follow-up, the clinical and therapeutic features of perianal disease were recorded. An adjusted time-dependent Cox model was used to evaluate the risk of evolution of anal ulcerations toward suppurative lesions. RESULTS: Among the 1,005 included patients (females, 450 [44.8%]; median age at diagnosis 14.4 years [interquartile range 12.0-16.1]), 257 (25.6%) had an anal ulceration at diagnosis. Cumulative incidence of anal ulceration at 5 and 10 years from diagnosis was 38.4% (95% confidence interval [CI] 35.2-41.4) and 44.0% (95% CI 40.5-47.2), respectively. In multivariable analysis, the presence of extraintestinal manifestations (hazard ratio [HR] 1.46, 95% CI 1.19-1.80, P = 0.0003) and upper digestive location (HR 1.51, 95% CI 1.23-1.86, P < 0.0001) at diagnosis were associated with the occurrence of anal ulceration. Conversely, ileal location (L1) was associated with a lower risk of anal ulceration (L2 vs L1 HR 1.51, 95% CI 1.11-2.06, P = 0.0087; L3 vs L1 HR 1.42, 95% CI 1.08-1.85, P = 0.0116). The risk of fistulizing perianal CD (pCD) was doubled in patients with a history of anal ulceration (HR 2.00, 95% CI 1.45-2.74, P < 0.0001). Among the 352 patients with at least 1 episode of anal ulceration without history of fistulizing pCD, 82 (23.3%) developed fistulizing pCD after a median follow-up of 5.7 years (interquartile range 2.8-10.6). In these patients with anal ulceration, the diagnostic period (pre vs biologic era), exposure to immunosuppressants, and/or anti-tumor necrosis factor did not influence the risk of secondary anoperineal suppuration. DISCUSSION: Anal ulceration is frequent in pediatric-onset CD, with nearly half of patients presenting with at least 1 episode after 10 years of evolution. Fistulizing pCD is twice as frequent in patients with present or past anal ulceration.

[Proctology]. / Proktologie.

This article provides a practice-oriented overview of the most common proctological diseases: Anal eczema, hemorrhoidal disease, anal thrombosis, marisca, anal abscess and fistula, and anal fissure. Definitions and etiopathogenesis, clinic and diagnostics, and current therapy are presented.

Botulinum toxin injection is an effective alternative for the treatment of chronic anal fissure.

OBJECTIVES: There are few published data on the optimized use of botulinum toxin A (BTA) for the treatment of chronic anal fissure (CAF). The aim of this study was to investigate the effect of injection of 100 IU BTA into the internal anal sphincter (IAS) at the side opposite of the fissure, using an anal retractor, sedation, and perianal transcutaneous pudendal nerve block. METHODS: The prospectively maintained data of 132 patients who underwent BTA injection for CAF were retrospectively analyzed. Demographic data, symptom duration, fissure location, post-procedure pain, complications, continence status, response to treatment, and follow-up period were investigated. Postoperative analgesic requirements of patients who did and did not receive pudendal nerve block were compared. RESULTS: Eighty-two patients were male and the median age was 40 (18-74) years. Sixty-six patients required no, 46 required oral, and 20 required parenteral analgesics. No complications were observed. Complete response was observed in 105 patients (79.5%). Symptomatic improvement was observed in 67.4% of patients within 3-7 d. Median follow-up was 24 (18-42) months. The median Wexner's incontinence score was 0 (0-8) at 1 month. In all, 104 patients had no, 22 patients had minor, and 6 patients had non-minor incontinence. All patients with incontinence recovered fully within 4 (2-13) weeks. CONCLUSIONS: BTA injection using an anal retractor under sedation and perianal transcutaneous pudendal nerve block is an effective and safe alternative to partial lateral internal sphincterotomy (LIS) for the treatment of CAF.

Effects of neuromodulation on treatment of recurrent anal fissure: A systematic review.

BACKGROUND: Anal fissure is a linear tear in the distal anoderm most frequently occurring in the posterior midline. Lateral internal sphincterotomy is considered the gold standard for the treatment of this condition. To this date, several pharmacological and neuromodulatory therapies have been tried out as alternative non-invasive treatments for anal fissures, however, the efficacy of some of these methods remains to be understood. OBJECTIVE: the primary aim of this study was to review available literature on neuromodulatory treatments for recurrent anal fissure as a potentially effective cure for this condition. DATA SOURCES: A search was conducted among five main online databases Embase, PubMed, Web of Science, Scopus, and Scholar. STUDY SELECTION: All published human studies in English literature addressing neuromodulation for the treatment of recurrent anal fissure were selected. INTERVENTION: neuromodulation for the treatment of anal fissure. We chose to include all articles in which the authors stated that the procedure they performed was via neuromodulation technique, or that the described technique used in their study resembled the technique. RESULT: Among a total of 3487 evaluated studies, seven represented the effects of neuro modulation on treatment of recurrent anal fissure, among which two were randomized controlled trials and the rest were prospective studies. A total of 186 patient were evaluated in these studies. The mean age of the participants was 46.97 ± 8.2. The average VAS score before intervention was 7.77 ± 2.13, which decreased to 0.31 ± 1.13 after intervention. LIMITATIONS: limitations of this study include the lack of related articles, and data regarding this subject. CONCLUSION: Posterior tibial nerve stimulation (PTNS) provides rapid pain relief and fissure healing especially in short-to mid-terms with little to no complications, however, using this treatment, symptoms of anal fissure do not improve as well as LIS, especially in the long-term.

Comprehensive literature review of the applications of surgical laser in benign anal conditions.

Surgery for benign anal conditions is a common practice and is usually followed by a good outcome. The present review aimed to summarize the emergence and evolution of different laser techniques used for the treatment of benign anal conditions and report their current outcome. PubMed and Scopus were searched for studies that assessed the use of laser in benign anal conditions. Anal conditions reviewed were hemorrhoids, anal fistula, anal warts, anal stenosis, and anal fissure. The full text of the studies retrieved was summarized in a narrative and tabular form. Laser techniques used for the treatment of hemorrhoidal disease were laser open hemorrhoidectomy, laser hemorrhoidoplasty, and Doppler-guided hemorrhoidal laser dearterialization. Resolution of hemorrhoidal symptoms was reported in 72-100% of patients after laser treatment. YAG laser, fistula laser closure, and photodynamic therapy have been used for the treatment of anal fistula with success rates ranging from 20 to 92.6%. Anal warts can be treated with photodynamic therapy with or without YAG or CO2 laser with a success rate up to 88%. A few studies reported the use of laser in the treatment of chronic anal fissure and anal stenosis. The use of laser in the treatment of benign anal conditions is associated with promising outcomes. Laser was most assessed in hemorrhoidal disease and anal fistula and showed more consistent success rates with hemorrhoidal disease than with anal fistula. Preliminary reports assessed the outcome of laser treatment in other conditions as anal fissure and warts with acceptable outcomes.

New Techniques in Hemorrhoidal Disease but the Same Old Problem: Anal Stenosis.

Anal stenosis, which develops as a result of aggressive excisional hemorrhoidectomy, especially with the stoutly use of advanced technologies (LigaSure®, ultrasonic dissector, laser, etc.), has become common, causing significant deterioration in the patient's quality of life. Although non-surgical treatment is effective for mild anal stenosis, surgical reconstruction is unavoidable for moderate to severe anal stenosis that causes distressing, severe anal pain, and inability to defecate. The problem in anal stenosis, unlike anal fissure, is that the skin does not stretch as a result of chronic fibrosis due to surgery. Therefore, the application of lateral internal sphincterotomy does not provide satisfactory results in the treatment of anal stenosis. Surgical treatment methods are based on the use of flaps of different shapes and sizes to reconstruct the anal caliber and flexibility. This article aims to summarize most-used surgical techniques for anal stenosis regarding functional and surgical outcomes.

Modified open posterior internal sphincterotomy with sliding skin graft for chronic anal fissure and anal stenosis: Low recurrence rate and no serious faecal incontinence postoperative complication.

AIM: Lateral internal sphincterotomy (LIS) remains a standard for chronic anal fissure even though other surgical techniques have shown high efficacy. Faecal incontinence is a well-documented complication of LIS. We devised modified open posterior internal sphincterotomy (m-OPIS) with sliding skin graft (SSG), which is a combined procedure of OPIS and anal advancement flap. The aim of this study is to evaluate m-OPIS+SSG. METHODS: This was a retrospective, observational, single-arm study. m-OPIS+SSG was performed for chronic anal fissure and anal stenosis. m-OPIS involved incision of the internal sphincter muscle at the posterior midline until four fingers could be passed. The incision wound was closed by anastomosis of the anoderm and skin. Then, an arcuate skin incision was created and the skin graft was advanced into the anal canal. Follow-up was conducted by clinical consultation and telephone interview. Faecal continence was assessed by Cleveland Clinic Faecal Incontinence (CCFI) score. RESULTS: m-OPIS+SSG was performed in 143 patients. The mean patient age was 50±16 years. The success and overall recurrence rates after m-OPIS+SSG were 99% and 0.7%, respectively, with a median follow-up period of 16.3 years. One patient developed incontinence with liquid stools once during the 6-month period. None of the other patients suffered permanent faecal incontinence postoperatively. The postoperative CCFI score was 0.5±0.9. CONCLUSIONS: We consider m-OPIS+SSG as one of the efficacious options of procedure for chronic anal fissure and anal stenosis, owing to its high success rate, low recurrence rate and no postoperative complication of serious faecal incontinence.

Results of surgical treatment in chronic anal fissure complicated by abscess or fistula in a retrospective cohort of patients.

We report the results of the surgical treatment of anal fissures complicated by abscess or fistula and formulate hypotheses about their nature. Among patients operated between 2012 and 2020 for anal fissure resistant to medical therapy, those affected by septic complications were selected for our inquiry. Surgical treatment consisted in the drainage of the sepsis, fissurectomy, posterior sphincterotomy and anoplasty. Intra-sphincteric fistulas were removed with the fissure, whereas low trans-sphincteric tracks, including horseshoe fistulas, were partially opened and curetted. Patients were followed on post-operative days 7-10 and then until healing. Pre- and post-operative Visual Analog Scale (VAS) and Cleveland Clinic Incontinence Score (CCIS) scores were compared. Recurrence rates of disease were recorded. We operated 988 patients and 55 of them showed local sepsis (5.5%) complicating anal fissures. There were 23 abscesses and 32 fistulas. Of these latter, 17 were intra or inter-sphincteric (2 anterior) and 15 low trans-sphincteric (6 horseshoes). Pre-operative VAS score was 7.6 ± 0.9 (mean ± sd), CCIS was 0.1 ± 0.5. Complete healing occurred after a median of 6 weeks (range 3-14 weeks). Mean VAS score dropped to 2.3 ± 0.6 at first follow-up visit and CCIS rose to 0.4 ± 0.2. After a mean of 56.4 months, 41 patients agreed to a visit and 14 were interviewed by phone. At office visit no disease recurrences were observed; pain and continence scores were within normal ranges in all patients. Abscess and fistula in anal fissures are not frequent and may represent a different disease from cryptoglandular fistulas. Surgical treatment achieves higher success than that reported for cryptoglandular fistulas.

Fisurectomy and anoplasty with botulinum toxin injection in patients with chronic anal posterior fissure with hypertonia: a long-term evaluation.

Chronic anal fissure's (CAF) etiopathogenesis remain unclear. CAF of the posterior commissure (CAPF) are often characterized by internal anal sphincter (IAS) hypertonia. The treatment of this disease aimed to reduce IAS hypertonia. Due to the high rate of anal incontinence after LIS, the employment of sphincter preserving surgical techniques associated to pharmacological sphincterotomy appears more sensible. The aim of our study is to evaluate the long-term results of fissurectomy and anoplasty with V-Y cutaneous flap advancement associated to 30 UI of botulinum toxin injection for CAPF with IAS hypertonia. We enrolled 45 patients undergone to fissurectomy and anoplasty with V-Y cutaneous flap advancement and 30 UI botulinum toxin injection. All patients were followed up for at least 5 years after the surgical procedure, with evaluation of anal continence, recurrence rate and MRP (Maximum resting pressure), MSP (Maximum restricting pressure), USWA (Ultrasound wave activity). All patients healed within 40 days after surgery. We observed 3 "de novo" post-operative anal incontinence cases, temporary and minor; the pre-operative ones have only temporary worsened after surgery. We reported 3 cases of recurrences, within 2 years from surgery, all healed after conservative medical therapy. At 5 year follow-up post-operative manometric findings were similar to those of healthy subjects. At 5 years after the surgical procedure, we achieved good results, and these evidences show that surgical section of the IAS is not at all necessary for the healing process of the CAPF.

Surgical Sphincter Saving Approach and Topical Nifedipine for Chronic Anal Fissure with Hypertonic Internal Anal Sphincter.

PURPOSE: The role of augmented internal anal sphincter (IAS) tone in the genesis of posterior chronic anal fissure (CAPF) is still unknown. Lateral internal sphincterotomy is the most employed surgical procedure, nevertheless it is burdened by high risk post-operative anal incontinence. The aim of our study is to evaluate results of sphincter saving procedure with post-operative pharmacological sphincterotomy for patients affected by CAPF with IAS hypertonia. Methods: We enrolled 30 patients, undergone fissurectomy and anoplasty with V-Y cutaneous flap advancement; all patients received topical administration of nifedipine 0.3% and lidocaine 1.5% ointment-based therapy before and for 15 days after surgery. The primary goal was patient's complete healing and the evaluation of incontinence and recurrence rate; the secondary goal included the evaluation of manometry parameters, symptom relief and complications related to nifedipine and lidocaine administration. Results: All wounds healed within 40 days after surgery. We didn't observe any de novo postoperative anal incontinence case. We reported 2 cases of recurrences, healed after conservative therapy. We didn't report any local complications related to the administration of the ointment therapy; with whom all patients reported a good compliance. Conclusions: Fissurectomy and anoplasty with V-Y cutaneous advancement flap and topical administration of nifedipine and lidocaine, is an effective treatment for CAPF with IAS hypertonia.

Anorectal diseases in patients with Antiphospholipid syndrome: a cross-sectional study.

BACKGROUND: Hemorrhoid disease (HD) is one of the most common gastrointestinal complaints worldwide, affecting 4.4% of the general population in the United States. Since antiphospholipid syndrome (APS) may lead to intra-abdominal thrombosis, one may expect that this condition can impact the risk for HD development. Additionally, as APS patients are more prone to thrombosis and treatment with anticoagulants may increase risk of bleeding, one may also infer that rates of HD complications may be higher in this scenario. Nevertheless, no data in these regards have been published until now. The objective of the present study is to evaluate frequency of HD and describe its complications rates in antiphospholipid syndrome APS patients. METHODS: We consecutively invited patients who fulfilled APS criteria to undergo proctological examination. After examination, patients were divided in two groups, based on the presence of HD, and compared regarding different clinical manifestations and antiphospholipid profile. We performed the analysis of the data, using chi-square and Mann Whitney U when applicable and considering a significance level of 0.05. Multivariate regression analysis included age and variables with p < 0.10 in the bivariate analysis. RESULTS: Forty-one APS patients agreed to undergo proctological examination. All were female and overall median age was 43 (36-49). Seventeen (41.4%) patients were diagnosed with HD, with the following frequency distribution: 7 internal (41.2%), 4 external (23.5%) and 5 mixed hemorrhoids (29.4%). Of the internal hemorrhoids, 5 patients were classified as grade I (71.4%), 1 grade II (14.3%), and 1 grade IV (14.3%). Prior gestation (p = 0.067) and constipation (p = 0.067) correlated with a higher frequency of HD. In multivariate analysis, constipation remained as an important risk factor (OR 3.92,CI95% 1.03-14.2,p = 0.037). Five out of 17 patients (29.4%) reported anal bleeding, but it did not correlate with warfarin dose (p = 0.949). Surgical treatment was indicated for 10 patients (58.8%). Other anorectal findings were anal fissure, plicoma, condyloma and one chlamydial retitis. CONCLUSION: We found an unexpected high frequency of hemorrhoids in APS patients, with a great proportion requiring surgical treatment.

Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2.

PURPOSE: To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures. METHODS: This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks. Primary endpoint was complete healing of the anal fissure after 12 weeks. Secondary endpoints included incidence of adverse events and efficacy on pain relief. RESULTS: In total, 55 patients were included. Inclusion was terminated prematurely due to a slow inclusion rate. Complete fissure healing at 12 weeks follow-up was overall achieved in 31 of 55 (56%) patients, 18 of 29 (62%) in the diltiazem group compared with 13 of 26 (50%) in the Levorag® Emulgel group (P = 0.424). Pain relief was significantly better at day seven in patients treated with diltiazem (P = 0.040) compared with Levorag® Emulgel, whereas there were no differences in early (3 days) or late (12 weeks) pain relief. Three patients (10.3%) developed severe perianal exanthema during diltiazem treatment, whereas no side effects were observed in the Levorag® Emulgel group. CONCLUSION: The study demonstrated statistical non-inferiority of Levorag® Emulgel compared with diltiazem in the treatment of chronic anal fissure. Diltiazem resulted in a more prompt pain relief and also in a substantial number of local allergic reactions. Levorag® Emulgel may therefore be an alternative in these patients. TRIAL REGISTRATION: Clinicaltrials.gov no. NCT02158013.

Rs531564 polymorphism in microRNA-214 regulates interleukin-6R expression in anal fissure patients to affect the risk of anal abscess formation.

BACKGROUND: Anal abscess is an important complication of anal fissure (AF), whereas interleukin-6R (IL-6R) has been implicated in the development of abscess. In this study, we aimed to explore the possible molecular mechanisms underlying the regulatory effects of miRNAs on IL-6R and other inflammatory factors related to the induction of anal abscess in AF. METHODS: Bioinformatics analysis, luciferase assay, real-time polymerase chain reaction, and Western blot analysis were performed to identify the possible regulatory relationships between IL-6R and miR-124/miR-125a by comparing the differentiated expression of miR-125a, miR-124, tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), and IL-4 among different groups of AF patients. RESULTS: IL-6R messenger RNA (mRNA) was identified as a target gene of miR-124 because the luciferase activity in cells cotransfected with wild-type IL-6R and miR-124 mimics was significantly reduced. In addition, the expression of IL-6R mRNA and protein was significantly inhibited in the presence of miR-124 or an IL-6R inhibitor, confirming the presence of a negative regulatory relationship between miR-124 and IL-6R. Moreover, miR-124 and inflammatory factors were differentially expressed in AF patients carrying different genotypes of rs531564 polymorphism. CONCLUSIONS: miR-124 and inflammatory factors TNF-α, IFN-γ, and IL-4 may be used as indicators of anal abscess development in AF patients. In addition, miR-124 polymorphism rs531564 is involved with the pathogenesis of anal abscess in AF patients, and the presence of rs531564 may increase the incidence of anal abscess via upregulating the expression of IL-6R, TNF-α, IFN-γ, and IL-4.

Percutaneous tibial nerve stimulation (PTNS): an alternative treatment option for chronic therapy resistant anal fissure.

BACKGROUND: The aim of the present study was to evaluate percutaneous tibial nerve stimulation (PTNS) for treatment resistant chronic anal fissure. METHODS: Consecutive patients with chronic anal fissure were treated with neuromodulation via the posterior tibial nerve between October 2013 and January 2014. Patients had PTNS for 30 min on 10 consecutive days. All patients had failed conventional medical treatment. The visual analogue scale (VAS) score, St. Marks score, Wexner's constipation score, Brief Pain Inventory (BPI-SF), bleeding and mucosal healing were evaluated before treatment, at termination, after 3 months, and then yearly for 3 years. RESULTS: Ten patients (4 males and 6 females; mean age 49.8 years) were identified but only 9 were evaluated as one patient's fissure healed before PTNS was started. At 3-year follow-up, fissures had remained completely healed in 5 out of 9 patients. All patients stopped bleeding and were almost completely pain-free at 3 years (VAS p = 0.010) and pain relief improved from 50% at completion to 90% at 3 years. The patients' Wexner constipation scores improved significantly (p = 0.007). CONCLUSIONS: In this small series, PTNS enhanced healing of chronic anal fissure and reduced pain and bleeding with an associated improvement in bowel function.

Epidemiology and outcomes of anal abscess in patients on chronic dialysis: a 14-year retrospective study.

OBJECTIVES: We conducted this retrospective study to elucidate the clinical presentation and outcomes of anal abscess in chronic dialysis patients. METHODS: We performed a chart review of patients who were hospitalized for anal abscess from Jan. 2002 to Dec. 2015. A total of 3,074 episodes of anal abscess were identified. Of these, 43 chronic dialysis patients with first-time anal abscess were enrolled. Patients were divided into a surgical group and a nonsurgical group according to the treatment received during hospitalization. The baseline characteristics, clinical findings, treatments and outcomes were obtained and analyzed. The endpoints of this study were in-hospital mortality, one-year mortality and one-year recurrence. RESULTS: Of the 43 patients, 27 (62.7%) received surgical treatment, and 16 (37.2%) received antibiotic treatment alone. There was no significant difference in age, sex, body mass index, smoking habits, comorbidities, or dialysis characteristics between the two groups. Perianal abscess was the most common type of anal abscess, and 39.5% of patients experienced fistula formation. Most patients had mixed aerobic and anaerobic flora. Our data demonstrate that there was no significant difference in hospital stay, one-year survival or recurrence rate between the surgical group and nonsurgical group. However, there was a trend toward better in-hospital survival in patients who received surgical treatment (p=0.082). CONCLUSION: In chronic dialysis patients with anal abscess, there was no statistically significant difference in clinical presentation and outcomes between the surgical and nonsurgical groups, although the surgical group had a trend of better in-hospital survival.

Psychometric properties of a questionnaire (HEMO-FISS-QoL) to evaluate the burden associated with haemorrhoidal disease and anal fissures.

AIM: Current questionnaires designed to evaluate the burden of haemorrhoidal disease ignore symptoms such as bleeding, pain and itching. A specific questionnaire is needed to evaluate the global impact of anal disorders on patients' daily lives. METHOD: We developed a questionnaire (HEMO-FISS-QoL) to assess the symptom burden of anal disorders and administered it to 256 patients (mean age 46.2 years; men 60.4%) with haemorrhoidal disease (67.2%), anal fissure (29.3%) or both (3.5%). Psychometric properties were evaluated by testing the acceptability, construct validity and reliability of the questionnaire. Principal components and multi-trait analyses were used to identify dimensions and to assess construct validity. Backward Cronbach alpha curves and a graded response model were used to reduce the number of items and modalities. External validity was evaluated against SF-12 and the Psychological Global Well-Being Index (PGWBI) using Spearman's correlation coefficient. RESULTS: Principal component analysis defined four dimensions: physical disorders, psychology, defaecation and sexuality. The number of questions was reduced from 38 to 23. The HEMO-FISS-QoL scores correlated well with those of the SF-12 and PGWBI (P < 0.001). Cronbach's coefficients (all > 0.7) reflected good internal reliability of the different dimensions. The total score increased with the severity of the anal disorders and with their consequences (days off work and personal spending related to the disease). CONCLUSION: The HEMO-FISS-QoL questionnaire reliably evaluates the global impact of haemorrhoids and anal fissures on patients' daily lives. This simple tool may prove useful for treatment evaluation in clinical trials and daily practice.