The Evaluation and Office Management of Hemorrhoids for the Gastroenterologist.

PURPOSE OF REVIEW: Hemorrhoid disease is extremely common, and seldom requires surgical intervention. The vast majority of patients can be cared for in the office setting and by the gastroenterologist. This piece aims to summarize the epidemiology and pathophysiology of hemorrhoid disease, along with the proper evaluation and office-based treatment of these patients. RECENT FINDINGS: Most GI fellowship training programs spend little time on these topics, and the recommendation has been made to include anorectal care in the GI's "core curriculum." The use of the anoscope and a proper anorectal examination are keys to evaluating these patients, and the techniques available to treat these patients are described. Often overlooked in these patients are other anorectal issues that occur alongside hemorrhoidal issues very commonly-the most common being anal fissure. Comprehensive management of all of these issues will allow all but the most severely affected patients to avoid the expense and morbidity of surgical intervention. The anatomy, etiology, pathophysiology, diagnosis, and non-surgical treatment of hemorrhoid disease are presented with the gastroenterologist in mind.

Evaluation and management of hemorrhoids: Italian society of colorectal surgery (SICCR) consensus statement.

Hemorrhoids are one of the most common medical and surgical diseases and the main reason for a visit to a coloproctologist. This consensus statement was drawn up by the Italian society of colorectal surgery in order to provide practice parameters for an accurate assessment of the disease and consequent appropriate treatment. The authors made a careful search in the main databases (MEDLINE, PubMed, Embase and Cochrane), and all results were classified on the basis of the grade of recommendation (A-C) of the American College of Chest Physicians.

[Situation-adjusted Treatment of Haemorrhoidal Disease]. / Situationsadaptierte Therapie des Hämorrhoidenleidens.

In addition to the stage several factors influence the treatment of haemorrhoids. The adequate treatment of haemorrhoids is not solely dependent on the stage, thus a situation-adapted therapy should be preferred. Advantages, disadvantages and specific characteristics of different therapy strategies in addition to potential complication risks have to be evaluated in order to obtain an effective and low-risk course. Also requests and personal living conditions of the patient as well as the expertise and experience of the physician have to be considered. A review of the current literature has been performed and a "four columns concept" has been developed that constitutes the fundament of a situation-adjusted treatment of haemorrhoids. The "four columns" that should be considered when therapy strategies are determined are composed of the following key factors: diagnostic findings, treatment alternatives, physician, and patient.

[Practical Implementation of the "Four-column Concept" in the Situation-Adjusted Therapy for Haemorrhoidal Disease in the Daily Routine of a Proctology Department]. / Praktische Anwendung des "4-Säulen-Konzepts" der situationsadaptierten Therapie des Hämorrhoidalleidens im alltäglichen Arbeitsfeld einer proktologischen Abteilung.

INTRODUCTION: In addition to the stage, several factors influence the treatment of haemorrhoids. The aim of this study was the elaboration of an individual therapy concept which is situation-adjusted. In this context, our own experience and approaches are presented. MATERIALS AND METHODS: In the Department of Coloproctology of the Prosper-Hospital Recklinghausen, from January 2009 to August 2012, 903 haemorrhoidectomies (2nd to 4th degree) have been performed. We report our results on the practical implementation of a situation-adjusted treatment of haemorrhoidal disease. In this context we present an overview of effective modifications of surgical techniques. Retrospectively the perioperative course and postoperative outcome were evaluated. RESULTS: Even in a collective with a large number of high-risk patients (26 %) respecting the "four columns" that constitute the fundament of a situation-adjusted treatment of haemorrhoids, high patient satisfaction and good outcome with low complication (7 %) and recurrence (0 %) rates could be attained. CONCLUSION: The "four columns" (findings of examination, therapeutic options, physician and patient) form the fundament of an effective treatment of haemorrhoidal disease without many complications and guarantee an individually tailored therapy for each patient.

Transanal dearterialization with targeted mucopexy is effective for advanced haemorrhoids.

AIM: Transanal haemorrhoidal dearterialization (THD) has become well established for the treatment of haemorrhoids. In this study we describe a technical modification of this technique, targeted mucopexy (THD TM), and report the results for advanced haemorrhoids. METHOD: The study included a prospective evaluation of patients with Grade IV (fourth-degree) haemorrhoids operated on with the THD TM technique. This consisted of an initial dearterialization when the haemorrhoidal arteries were transfixed and a second phase of mucopexy, using a different needle from that usually used in the original technique. RESULTS: From January 2007 to December 2011, 31 consecutive patients with Grade IV haemorrhoids were operated on using the THD TM technique. Postoperative pain was reported by 22 (70%) patients on day 1 and 19 (61%) on day 7, while nine (30%) did not experience any pain at all. Severe pain was reported by only nine (16%) patients. At a mean follow-up of 32 months, two (6.4%) patients required a further intervention for on-going symptoms. CONCLUSION: Transanal haemorrhoidal dearterialization TM is effective for advanced haemorrhoids.

A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids.

BACKGROUND: Doppler guidance in hemorrhoidal surgery has become more frequent during the past decade. The method is mainly studied in nonrandomized trials. Data from randomized controlled trials are lacking. OBJECTIVE: The aim of this study was to compare early and midterm results of transanal hemorrhoidal dearterialization with anopexy to open hemorrhoidectomy. DESIGN, SETTINGS, PATIENTS, AND INTERVENTIONS: Forty patients with grade 2 to 3 hemorrhoids were randomly assigned to transanal hemorrhoidal dearterialization with anopexy (group A, n = 20) or open hemorrhoidectomy (group B, n = 20). A diary was used during the first 2 postoperative weeks. A self-reported symptom questionnaire was answered, and a clinical examination was performed preoperatively, after 2 to 4 months, and after 1 year. MAIN OUTCOME MEASURE: The main outcome measure was postoperative pain. RESULTS: Postoperative peak pain was lower in group A during the first week than in group B (p < 0.05), whereas no difference in overall pain was noted. More patients expressed normal well-being in group A (p = 0.045). Pain, bleeding, and the need for manual reduction of the hemorrhoids were all improved in both groups after 1 year (p < 0.05). Soiling had decreased after both methods at early follow-up. After 1 year, soiling was significantly decreased only after open hemorrhoidectomy. The grade of hemorrhoids was significantly reduced after 1 year for both methods, but there was a trend to more patients with remaining grade 2 hemorrhoids in group A (p = 0.06). LIMITATIONS: There was no blinding, the sample size was small, and follow-up was for only 1 year. The questionnaire was not validated. CONCLUSION: The difference in postoperative pain between transanal hemorrhoidal dearterialization with anopexy and open hemorrhoidectomy may be less than expected based on previous literature.

Prospective randomized multicentre study comparing stapler haemorrhoidopexy with Doppler-guided transanal haemorrhoid dearterialization for third-degree haemorrhoids.

AIM: Doppler-guided transanal haemorrhoid dearterialization (THD) and stapler haemorrhoidopexy (SH) have been demonstrated to be less painful than the Milligan-Morgan procedure. The aim of this study was to compare the effectiveness of THD vs SH in the treatment of third-degree haemorrhoids in an equivalent trial. METHOD: One hundred and sixty-nine patients with third-degree haemorrhoids were randomized online to receive THD (n = 85) or SH (n = 84) in 10 Colorectal Units in which the staff were well trained in both techniques. The mean follow-up period was 17 (range 15-20) months. RESULTS: Early minor postoperative complications occurred in 30.6% of patients in the THD group and in 32.1% of patients in the SH group. Milder spontaneous pain and pain on defecation were reported in the THD group in the first postoperative week, but this was not statistically significant. Late complications were significantly higher (P = 0.028) in the SH group. Residual haemorrhoids persisted in 12 patients in the THD group and in six patients in the SH group (P = 0.14). Six patients in the SH group and 10 in the THD group underwent further treatment of haemorrhoids (P = 0.34). No differences were found in postoperative incontinence. The obstructed defecation score (ODS) was significantly higher in the SH group (P < 0.02). Improvement in quality of life was similar in both groups. Postoperative in-hospital stay was 1.14 days in the THD group and 1.31 days in the SH group (P = 0.03). CONCLUSION: Both THD and SH techniques are effective for the treatment of third-degree haemorrhoids in the medium term. THD has a better cost-effective ratio and lower (not significant) pain compared with SH. Postoperative pain and recurrence did not differ significantly between the two groups.

[Health-related quality of life after surgical haemorrhoid treatment - results, methods and problems]. / Gesundheitsbezogene Lebensqualität nach operativer Hämorrhoidaltherapie - Ergebnisse, Methoden und Probleme.

In patients suffering from haemorrhoidal disease a hyperplasia of the corpus cavernosum recti is accompanied by various symptoms such as anal bleeding and minor continence disorders as well as itching, soiling and burning. According to the morphological findings, haemorrhoids are staged from grade I up to IV. Therapy strategies are adjusted to this staging. Early stages are treated by conservative measures, such as regulation of defaecation, sclerosis and rubber band ligations. Advanced stages require operative methods, such as segmental excision and stapled haemorrhoidopexy. Since patients demand a greater regard to the subjective experience of their disease and its treatment, quality of life evaluation has become an important issue in medical care. Therefore health-related quality of life is increasingly becoming a relevant primary or secondary end point of clinical studies. Since up to 4 % of the general adult population in industrial nations is annually diagnosed to suffer from haemorrhoidal disease, in Germany per annum 3.5 Mio patients seek medical advice due to this condition and 40 000-50 000 surgical procedures are performed. Nevertheless only very few studies have been carried out to investigate the influence of this widespread disease on the quality of life of those patients. Additionally cost-effectiveness analyses measuring quality-adjusted life years are becoming more and more decisive in health politics. The present article discusses the definitions of health-related as well as disease-related quality of life. Different psychometric tests applied to evaluate the quality of life are summarised, quality criteria are outlined and limitations discussed. Several studies were analysed in regard to the quality of life in patients with haemorrhoidal disease and the specific influence of different operative techniques was reviewed.

[Multiple vertical ligatures: A new approach to the treatment of haemorrhoidal disease grade III. Safety and efficacy study]. / Ligaduras múltiples verticales: un nuevo enfoque en el tratamiento de la enfermedad hemorroidal grado III. Estudio de seguridad y eficacia.

INTRODUCTION: The elastic ligature is the most used method for the out-patient treatment of haemorrhoids, with excellent results in control of bleeding. However, the recurrences in prolapse vary between 15 and 40%. We propose a new method for applying the elastic ligatures. PATIENTS: A total of 17 patients with grade iii haemorrhoids were chosen for the vertical ligatures (VL). The first elastic band was placed 3 to 4 cm from the pectineal line and 1 or 2 more in the root of the haemorrhoid group. Another 34 randomly selected patients were used as a control group. Data collected included, demographic details, number of bands and sessions, pain scale, complications and results. The patients were followed up at week one, week 3, and 3 months and one year after the intervention. RESULTS: A total of 12 males and 5 females, with a median age of 46 years, were treated with VL. The median follow-up was 10 (from 8 to 19) months. A median of 3 sessions and 7 elastic bands were used, with 6 patients having moderate pain that required analgesic treatment. None of the patients needed urgent treatment for pain or bleeding. There was a complete response to bleeding in 15 patients (88.2%) and to prolapse in 14 (82.2%). Two patients required haemorrhoidectomy due to treatment failure. The measurements of therapeutic effect after one year were: number needed to treat (NNT) of 4 (95% CI, 2 to 22), for prolapse, and NNT of 4 (95% CI, 2 a 15), for bleeding. CONCLUSIONS: Elastic ligatures could become a new treatment option for Grade iii haemorrhoids, improving control of bleeding and prolapse.

Stapled haemorrhoidopexy vs. Milligan-Morgan haemorrhoidectomy for grade III haemorrhoids: a randomized clinical trial.

The aim of this double blind randomized clinical trial was to compare the short-term and long-term outcomes of stapled haemorrhoidopexy (SH group) performed using a circular stapler with that of the Milligan-Morgan haemorrhoidectomy (MMH group). A total of 79 consecutive patients with grade III haemorrhoids were randomized into two groups treated with SH (n. 39) and MMH (n. 40). The outcomes of the procedures were evaluated postoperatively and over a follow-up period of minimum 2 years. Patients undergoing the SH procedure showed greater short term advantages than MMH group with reduced pain, shorter length of hospital stay, earlier return to work and high patient satisfaction. Long-term follow-up has indicated more favourable results in MMH group in terms of resumption of symptoms with absence of residual prolapse and risk of recurrence of prolapse. At two years follow-up recurrent prolapse was confirmed in six patients of SH group (13%) whereas in none of the MMH group. At six months follow-up there weren't significant difference in the mean satisfaction score for the two groups. At two years the mean satisfaction score was higher in the MMH group vs SH group. Seven patients in the SH group needed a reoperation whereas none in MMH group. From January 2009, in our Surgery Unit the patients are always informed about a higher recurrence rate of SH and we perform this technique only when the patient choices to accept this risk to take advantage of the short-term benefits of this procedure.

Doppler-guided hemorrhoidal artery ligation and rectoanal repair (HAL-RAR) for the treatment of grade IV hemorrhoids: long-term results in 100 consecutive patients.

BACKGROUND: Doppler-guided hemorrhoidal artery ligation is a minimally invasive technique for the treatment of symptomatic hemorrhoids that has been applied successfully for grade II and III hemorrhoids but is less effective for grade IV hemorrhoids. Development of a special proctoscope enabled the combination of hemorrhoidal artery ligation with transanal rectoanal repair (mucopexy), which serves to lift and then secure the protruding hemorrhoids in place. OBJECTIVE: The purpose of this study was to describe our experience with this combined procedure in the treatment of grade IV hemorrhoids. DESIGN: Prospective observational study. SETTING: Outpatient colorectal surgery unit. PATIENTS: Consecutive patients with grade IV hemorrhoids treated from April 2006 to December 2008. INTERVENTION: Hemorrhoidal artery ligation-rectoanal repair. MAIN OUTCOME MEASURES: Operating time, number of ligations, number of mucopexies and associated procedures, and postoperative symptoms were recorded. Pain was graded on a visual analog scale. Follow-up was at 2, 6, and 12 months after surgery, and then annually. RESULTS: A total of 100 consecutive patients (64 women, 36 men) with grade IV hemorrhoids were included. Preoperative symptoms were bleeding in 80 and pain in 71 patients; 19 patients had undergone previous surgical treatment for the disease. The mean operative time was 35 (range, 17-60) minutes, with a mean of 9 (range, 4-14) ligations placed per patient. Eighty-four patients were discharged on the day of the operation. Nine patients developed early postoperative complications: pain in 6, bleeding in 4, dyschezia in 1, and thrombosis of residual hemorrhoids in 3. Late complications occurred in 4 patients and were managed conservatively. Recurrence was observed in 9 patients (9%), with a mean follow-up of 34 (range, 14-42) months. LIMITATIONS: The 2 main weaknesses of the study were the lack of very long-term follow-up and the absence of a comparison with hemorrhoidectomy or hemorrhoidopexy. CONCLUSION: Doppler-guided hemorrhoidal artery ligation with rectoanal repair is safe, easy to perform, and should be considered as an effective option for the treatment of grade IV hemorrhoids.

Haemorrhoids, constipation and faecal incontinence: is there any relationship?

AIM: Little is known about the association of haemorrhoids and anorectal function. Moreover, available data on the impact of constipation on the presence of haemorrhoids are conflicting. The present study aimed to assess any potential relationship between haemorrhoids and anorectal dysfunction. METHOD: All participants who attended the Austrian nationwide healthcare programme for colorectal cancer screening at four medical institutions were enrolled prospectively between 2008 and 2009. A colonoscopy and detailed anorectal examination were performed on all patients. Haemorrhoids were classified according to an international grading system. Faecal incontinence was defined as the involuntary loss of solid stool, liquid stool or gas, at least once a month. Constipation was recorded by a constipation scoring system. RESULTS: Of 976 participants, 380 (38.9%) were found to have haemorrhoids. There was an association between healthy individuals, patients with symptomatic and patients with asymptomatic haemorrhoids and incontinence of liquid stool. No association was found regarding incontinence for solid stool and gas. The median constipation score was significantly higher in those patients with haemorrhoids (grade I-IV) compared with patients without haemorrhoids (2.5 points (range, 0-19) and 3 points (range, 0-19); P = 0.0113). 'Painful evacuation effort' and 'assistance for defaecation (stimulant laxatives, digital assistance or enema)' showed a significant correlation with haemorrhoids (P = 0.0394 and P = 0.0143). CONCLUSION: Although the median constipation score was low in both groups, there was a significant association between constipation and haemorrhoids in adult patients.

Transanal haemorrhoidal dearterialization (THD) for selected fourth-degree haemorrhoids.

BACKGROUND: Traditional treatment of fourth-degree haemorrhoidal disease (HD) is conventional haemorrhoidectomy and is frequently associated with significant pain and morbidity. In recent years, the use of transanal haemorrhoidal dearterialization (THD) for the treatment of HD has increased. The procedure aims to decrease the arterial blood flow to the haemorrhoids. Moreover, since a rectal mucopexy to treat the prolapsing component has become part of the THD technique, this treatment is also indicated for more advanced HD. The aim of this study was to assess the possible role of THD in the treatment of fourth-degree HD. METHODS: All patients with non-fibrotic fourth-degree HD were offered the THD procedure with mucopexy. Excision of skin tags was added to THD and mucopexy, when needed. A specific score was used to assess HD severity, ranging from 0 (no HD) to 20 (worst HD). The mean preoperative score was 18.1 ± 1.8. RESULTS: Thirty-five consecutive patients (mean age 50.4 ± 13.8 years; 19 men) with fourth-degree HD were prospectively enroled. An average of 6 arteries were identified and transfixed. Mucopexy was achieved with a 3-6 sector plication of rectal mucosa. Mean operating time was 33 ± 12 min. No intraoperative complications were recorded. Postoperative morbidity included 3 (8.6%) haemorrhoidal thromboses (1 requiring surgery) and 2 (5.7%) episodes of bleeding (1 requiring surgical haemostasis). Five patients (14.3%) had urinary retention requiring catheterization. At a median follow-up of 10 months (range 2-28 months), symptoms had resolved or significantly improved in 33 (94%) patients. Nine patients (25.7%) reported irregular bleeding, 3 patients (8.6%) mild anal pain, 4 patients (11.4%) transient anal burning and 4 patients (11.4%) tenesmus. Ten patients (28.6%) experienced some degree of residual prolapse, significant only in 2 (5.7%) who required further surgery. There was no anorectal stenosis, and no faecal incontinence was reported. At a median follow-up of 10 months, the symptomatic score was 2.5 ± 2.5 (P < 0.005). CONCLUSION: Transanal haemorrhoidal dearterialization seems to be a safe and effective treatment for fourth-degree HD providing a significant improvement of symptoms for the majority of patients. When present, persisting symptoms are mostly transient, occasional or limited in severity, and only a very few patients require further intervention. Larger series and longer follow-up to further assess the role of THD in this challenging group of pts.

Surgical treatment for IV-degree hemorrhoids: LigaSure™ hemorroidectomy vs. conventional diathermy. A prospective, randomized trial.

AIM: Milligan-Morgan operation is still considered the treatment of choice for IV-degree haemorrhoids: it is frequently associated with significant postoperative pain and prolonged hospital stay. Many instruments were conceived to reduce these complications, such as the LigaSure™ (LS) system, a combination of radiofrequency and pressure that seems mainly effective where a large tissue demolition is required. This randomized study is METHODS: Fifty-two patients with IV-degree hemorrhoids were randomly assigned to two different surgical treatments (conventional diathermy vs. LigaSure™ hemorrhoidectomy). They were evaluated on the basis of the following main outcomes: mean operative time, postoperative pain, day of discharge early and late complications. The time of recovery of work was also assessed. All patients had a minimum follow-up of twelve months (range 12-24). All data were statistically evaluated. RESULTS: Twenty-seven patients were treated by conventional diathermy, 25 by LigaSure™. The mean operative time was significantly shorter in LS, such as postoperative pain, mainly lower on the third and fourth postoperative day: moreover pain disappeared earlier in LS than CD. The time off-work was shorter in LS, while there was no difference in hospital stay and overall complications rate . CONCLUSION: This randomized prospective controlled trial confirms, according to other large trials in literature , the benefits of the LigaSure™ hemorrhoidectomy over conventional diathermy when a large tissue demolition is required, supporting the use of this device as treatment of choice in IV degree hemorrhoids, even if the procedure is more expensive than conventional operation.

Doppler-guided hemorrhoidal artery ligation (DG-HAL): a safe treatment of II-III degree hemorrhoids for all patients. Could it be potentially also good prophylaxis?

AIM: Doppler-guided hemorrhoidal artery ligation (HAL Doppler) is an innovative hemorrhoid treatment mainly utilised for II-III degree where bleeding is a predominant symptom. This procedure aims at dearterialization of the internal hemorrhoidal plexus by ligation of the terminal branches of the superior rectal artery detected using a special proctoscope and ultrasound system; the procedure is performed entirely above the dentate line, so it is genuinely painless. The aim of this study was to evaluate the efficacy, safety and invasivity of HAL Doppler technique to treat II and III degree hemorrhoids. METHODS: The authors treated 148 patients, from May 2002 to December 2007, principally affected by II-III degree hemorrhoids characterized by bleeding and pain at evacuation. These patients were examined in a retrospective observational study of 128 patients, 86% of the group. Follow-up varied from 5 up to 72 months with an average observation time of 36.5 months. RESULTS: Success was registered in 90% of patients affected by II-III degree hemorrhoids and the absence of major complications (hemorrhage, incontinence, stenosis, perforation, sepsis). CONCLUSION: The authors suggest the safety, efficacy and low invasity of HAL Doppler for treatment of II-III degree hemorrhoids, which also found in the literature, and highlight its use in treating patients with unhealthy conditions which are a contraindication to the usual surgical treatments. Moreover, they suppose the use of HAL Doppler in low degree hemorrhoids as a therapeutic and also prophylactic rule of advanced degree.

Assessment and treatment of patients with haemorrhoids.

This article examines the care of patients with haemorrhoids, and explores the aetiology, epidemiology and assessment of the condition. Information is provided on the different forms of treatment, and the importance of lifestyle interventions is reinforced. The post-operative nursing care of patients undergoing surgical procedures, including haemorrhoidectomy, is discussed, emphasising pain relief, hygiene and prevention of constipation.

TRANSANAL HAEMORRHOIDAL DEARTERIALIZATION WITH MUCOPEXY (THD-M) FOR TREATMENT OF HEMORRHOIDS: IS IT APPLICABLE IN ALL GRADES? BRAZILIAN MULTICENTER STUDY.

BACKGROUND: Transanal haemorrhoidal dearterialization with mucopexy (THD-M) is a valuable option for treating patients with haemorrhoidal disease. However, there is still controversy with regard to its efficacy for more advanced grades. AIM: To evaluate the effectiveness of THD-M technique for treating hemorrhoidal disease and to compare the immediate and late results in different grades. METHOD: Seven hundred and five consecutive patients with Goligher's grade II, III or IV symptomatic haemorrhoids underwent surgical treatment using the THD-M method in five participating centres. Six well-trained and experienced surgeons operated on the patients. Average follow-up was 21 months (12-48). RESULTS: Intraoperative complications were observed in 1.1% of cases, including four cases of haematoma, two of laceration of the mucosa, and two of bleeding. All of these were controlled by means of haemostatic suturing. In relation to postoperative complications, the most common of these were as follows: transitory tenesmus (21.4%); pain (7.2%); mucosal or haemorrhoidal prolapse (6.4%); residual skin tag (5.6%); faecal impaction (3.2%); haemorrhoidal thrombosis (2.8%); bleeding (2.1%); anal fissure (0.7%); and anal abscess (0.3%). Most of the complications were treated conservatively, and only 7.5% (53/705) required some type of surgical approach. There was no mortality or any severe complications. The recurrence of prolapse and bleeding was greater in patients with grade IV haemorrhoidal disease than in those with grade III and II (26.54% and 7.96% vs. 2.31% and 0.92% vs. 2.5% and 1.25%), respectively. CONCLUSION: The THD-M method is safe and effective for haemorrhoidal disease grades II and III with low rates of surgical complications. However, for grade IV hemorrhoids, it is associated with higher recurrence of prolapse and bleeding. So, THD-M method should not be considered as an effective option for the treatment of grade IV hemorrhoids.

Relief of hemorrhoid symptoms: pilot study of a new topical ally.

AIM: The pathogenesis of hemorrhoids involves vascular congestion, fragmentation of supporting tissues and, in many cases, increased resting anal pressure. A new ointment (Hemolen®) has been devised to control hemorrhoids symptoms acting on all the pathophysiologic mechanisms involved. METHODS: Pilot study on patients with grade I-III hemorrhoids. The ointment was applied twice daily for 30 days and follow-up visits were scheduled 7 days (T1), 14 days (T2) and 30 days (T3) after recruitment (T0). Signs and symptoms (bleeding, discomfort, itching, edema, thrombosis, congestion, inflammation, pain) were evaluated at each visit using dedicated scores and VAS scale. Resting anal pressure was measured at time T0, 1 hour after the first application and at T1. Use of painkiller was recorded. RESULTS: 48 patients (25 females; mean age 47±15.8 years) were enrolled; 52.1% of them had II degree hemorrhoids and 27.1% had III degree hemorrhoids. The severity scores significantly dropped from T0 to each scheduled visit and a significant reduction of resting anal pressure was observed from T0 to 1 hour after application (z=13.5; p<0.001) and from T0 to T1 (z=6; p<0.001). The comparison of the resting pressure among whole time series showed a significant reduction (Fr=124.4; p=<0.001). Use of pain-killers decreased significantly from T0 to T1 (p<0.001) and from T1 to T2 (p=0.001). CONCLUSION: The new ointment tested in the present study is safe and effective for the management of hemorrhoid symptoms in the early stages hemorrhoids, during the acute phases and in patients with more severe hemorrhoids awaiting surgery. Prospective, randomized controlled trials are needed to confirm these encouraging results.