Safety and efficacy of topical drug-free cream in subjects with hemorrhoidal disease: a randomized, double blind, clinical trial.

BACKGROUND: Hemorrhoidal disease (HD) is one of the most common anorectal benign disorder affecting millions of people around the world. Grade I-II HD are generally treated with a conservative approach with topical products such as creams and ointments considered a safe and effective option to treat mild symptoms. The aim of the present study was to assess the safety and efficacy of a topical medical device (Lenoid™; International Health Science [IHS] - Biofarma Group, Mereto di Tomba, Udine, Italy) in patients affected by symptomatic HD. METHODS: This study is a randomized, double blind, placebo-controlled, 2-weeks clinical trial. Patients affected by I-II grade symptomatic HD were enrolled in the study and then randomly assigned to Lenoid™ arm (LA) or placebo arm (PA), respectively. Patients were evaluated before and after intervention through clinical examination and disease-specific questionnaires assessing symptoms such as pain, tenesmus, pruritus and anal discharge. RESULTS: A total of 68 patients were screened and 60 (30 in each group) were enrolled into the study. All patients belonging to LA showed a statistically significant improvement of each symptom after 7 and 14 days of treatment when compared to PA (P<0.001). Furthermore, subjective improvement of change in overall assessment of disease was observed in the LA but not in the PA. No serious adverse events were recorded. CONCLUSIONS: The tested product was found safe and effective in improving clinical signs and symptoms in patients with grade I-II HD.

The Significant Role of Nutraceutical Compounds in Ulcerative Colitis Treatment.

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) mainly affecting the colon and the rectum. Its main characteristics include relapsing and remitting mucosal inflammation, starting in the rectum and typically extending continuously proximally through part of or the entire colon. UC pathogenesis depends on multiple factors, such as genetic predisposition, defects in the epithelial barrier, dysregulated immune responses, and environmental causes. The most frequent symptoms are abdominal pain, weight loss, mucus discharge, bloody diarrhoea, incontinence, nocturnal defecations, fever, and anemia. Existing therapies for UC include 5-aminosalicylic acid (5-ASA) and its derivatives, steroids, immunosuppressants, and biological drugs. However, limited efficacy and unwanted adverse effects hardly limit these strategies of treatment. In the last decades, research studies have been driven towards complementary and alternative medicines for the treatment of UC. Various nutraceuticals have exhibited promising results in modulating intestinal inflammation while improving symptoms. These compounds possess a wide spectrum of positive health effects evidenced by in vitro studies, characterized by their involvement in antioxidant defenses, cell proliferation, and gene expression. The present review analyzes the available data about the different types of nutraceuticals and their potential effectiveness as adjuvant therapy of IBD, with particular emphasis to UC.

Stapled Surgery for Hemorrhoidal Prolapse: From the Beginning to Modern Times.

INTRODUCTION: Hemorrhoidal disease is the most common proctologic condition in adults. Among the different surgical procedures, one of the greatest innovations is represented by the stapled hemorrhoidopexy. The history of this technique started with a single stapler use passing through a double stapler technique to resect the adequate amount of prolapse, finally coming to the use of high volume devices. METHODS: Nevertheless, each device has its own specific feature, the stapler is basically made up with one or more circular lines of titanium staples whose height may be variable. The procedure is based on different steps: Introduction of the CAD, evaluation of the prolapse, fashioning purse string or parachute suture, the introduction of the stapler head beyond the suture, pull the wires through the window, close the stapler and keep pulled the wires of the suture held together with forceps, fire using two hands, open the stapler and remove it and check the staple line and then check the specimen. One of the latest innovations in stapled surgery is Tissue Selective Therapy. It is a minimally invasive procedure in which there is a partial circular stapled hemorrhoidopexy focused on the prolapsing piles with bridges of normal mucosa left. RESULTS: Several studies have reported that SH is a safe and effective procedure to treat hemorrhoidal prolapse. It is a quicker procedure with a shorter hospital stay and earlier return to work if compared with the conventional treatment. This is due to less postoperative pain, postoperative bleeding, wound complications and constipation. Furthermore, the first generation devices had worse outcomes if compared with those of the new generation stapler that showed lower postoperative complication rates with better anatomical and symptomatic results. CONCLUSION: Stapled procedure for the treatment of symptomatic hemorrhoidal prolapse represents one of the most important innovations in proctology of the last century bringing with it the new revolutionary concept of the rectal intussusception as a determining factor involved in the natural history of the disease. Stapled hemorrhoidopexy marked an era in which the surgeon may offer the patients a safe, effective treatment with less pain and fast recovery.

Improvement in Hemorrhoidal Disease Surgery Outcomes Using a New Anatomical/Clinical-Therapeutic Classification (A/CTC).

Introduction The introduction and diffusion of new techniques for hemorrhoidal surgery have made it clear how much Goligher classification is inadequate in the modern times, lacking in any correlation between anatomical and clinical features to a surgical procedure. The aim of the study was to evaluate if the application of a new classification of hemorrhoidal diseases might lead to an improvement in the postoperative surgical outcomes. Methods From January 2014 to December 2015, all patients undergoing surgery for hemorrhoidal disease were enrolled. The procedures performed were based upon a new anatomical/clinical-therapeutic classification (A/CTC) considering these items: anatomical presentation, symptom types and frequency, associated diseases, and available surgical treatments and their related contraindications. The new classification identified four groups: A (outpatient), B, C, and D (surgical approaches). The overall outcomes were assessed and then stratified by surgical groups. These data were then analyzed in comparison with the published data about all the surgical procedures performed. Results A total of 381 patients underwent surgery and they were stratified as follows: Group B (39), C (202), and D (140). Group B underwent Doppler-guided dearterialization with mucopexies or tissue selective therapy, Group C stapled procedures, and Group D hemorrhoidectomy. The mean follow-up was 30 months. The overall outcomes were: success rate 92.4%, recurrences 7.6%, postoperative complications 4.8%, long-term complications 5.4%, and reoperation rate 2.7%. The success rates stratified by groups were: B, 85%); C, 91.4%; and D, 95.7%. Conclusion The A/CTC proved to be useful in stratifying the patients and choosing the proper treatment for each case. This classification seems to improve the outcome of different surgical procedures if compared with those already published.

Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial.

INTRODUCTION: Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group. MATERIALS AND METHODS: From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group. RESULTS: A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded. CONCLUSION: The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.

[Transrectal ultrasonography by rotating feeler in the perianal fistulae/abscesses surgery. Anatomo-functional description]. / L'ecografia endorettale con sonda rotante nella chirurgia degli ascessi e fistole anali. Descrizione anatomo-funzionale.

INTRODUCTION: Anal fistula represents a big topically subject above all as regards the complex correlated surgical implications. The transectal ultrasonography (TUS) is the first help for a careful, cheep, poorly invasive diagnosis. MATERIALS AND METHODS: From September 2002 to December 2003 we submitted TUS 53 patient with clinical diagnosis of perianal fistula abscesses and 27 patients, already subordinates to surgical intervention for perianal fistulae/abscesses, which only presented perianal pain without clear signs of perianal pathology (48 males and 15 females). RESULTS: TUS diagnosis and surgical confirmation of abscess and/or anal fistulae in all the patients; in the 27 patients, in whom at clinician exam was not clear an abscess, it was diagnosed in 21 patients (6 positive-false). DISCUSSION: The obtained data show the validity of this methodical diagnostics and its importance for a correct surgical management. The 7.2% of discovered positive-false (surgical response: scary tissue), they are to charge to the objective technical dfficulty with discriminating scary outcomes; in confirmation of that the datum that in all these cases the patients had already been submitted to previous ano-rectal surgery. CONCLUSIONS: Surgery of the anal abscesses and fistulas, for effective being, must stay in balance between aggressiveness and safeguards surgery. Surgery, to be correct, cannot leave out of consideration TUS: a valid tool in the Pre-operatory diagnosis, but also in the Post-operatory phase to highlight possible recidivisms.