Reviews on Recent Clinical Trials - Volume 16, Issue 1, 2021

Background: Hemorrhoidal disease is a widespread problem in healthy working patients. The traditional surgical approaches cause a loss of several working days related to the post-- operative course that is often painful. To avoid these problems while offering a symptoms resolution in patients with low degrees hemorrhoids, the non-surgical treatments are nowadays largely proposed in proctological clinics. Methods: We resume the recent literature on the issue to offer a practical and easy to use guide for clinicians. Results: Rubber band ligation, injection sclerotherapy and infrared coagulation are cost effective, safe and effective treatments for patients with II- and III-degree hemorrhoids. Relapses are commons even if the procedures can be repeated until symptoms resolution. IV-degree hemorrhoids are not suitable of these treatments. Conclusion: The proctological clinics must evaluate the quality of life offered to patients and discuss with them the appropriate treatment in order to select the most appropriate one for symptoms resolution and disease cure. Less is not always the best but can be an alternative to be offered.

Background: Haemorrhoidal disease (HD) is a benign condition affecting a considerable part of adult population. HD can be considered a social and economic burden with high impact on patients’ lifestyle. Several new techniques and devices have been proposed for HD treatment; however, preoperative assessment is essential and the use of classification system is recommended. Methods: In the last two decades many studies described the preoperative assessment and several attempts of classification for HD. This review focuses on the most relevant studies found in literature where classification systems and clinical evaluation with differential diagnosis have been evaluated. Results: The knowledge of classification systems and differential diagnosis for HD has been shown to play a central role in the clinical assessment and the best treatment choice. Although there are new challenging techniques and devices for HD treatment, a preoperative assessment is always mandatory. Conclusion: Preoperative clinical evaluation is essential for HD patient treatment and outcome. Classification systems are useful for the therapeutic choice and researches on new medical or surgical treatments. In fact, the international guidelines advise several therapeutic options depending on the severity of the HD.

Background: Minimally-invasive treatments for hemorrhoids should be encouraged as they cause low morbidity, reasonable discomfort and quicker return to work. According to the “vascular theory”, hemorrhoidal disease is mainly caused by blood overflow into hemorrhoidal plexus deriving from the superior hemorrhoidal arteries. Introduction: Many different procedures have been described in the literature with the common goal of reducing the blood flow into the hemorrhoidal piles. ‘HeLP’ (Hemorrhoids Laser Procedure) is a novel form of dearterialization to treat patients suffering from symptomatic hemorrhoids. Methods: The procedure consists of the closure of the terminal branches of the superior rectal artery approximately 2-3 cm above the dentate line by means of laser shots originated by a diode laser platform. The arteries, at that level, have variable location and distribution. Therefore, a doppler probe set at the frequency of 20MHz helps identifying the arteries that would be missed otherwise. The laser beam is well tolerated by patients. For this reason, anesthesia is not required in most cases and the procedure allows a quick return to daily activities. In the case of concomitant severe mucosal prolapse, laser treatment can be combined with suture mucopexy. Three to six running sutures allow a complete lifting of hemorrhoidal piles, securing a long-term resolution of symptoms. Results: ‘HeLP’ is indicated in patients with symptomatic hemorrhoids where conservative treatment failed and when mucosal prolapse is scarce or not symptomatic. The addition of mucopexy to laser treatment (HeLPexx) contributes to the overall resolution of symptoms when mucosal prolapse is an issue. Conclusion: Emborrhoid is another novel, ‘hi-tech’ form of selective dearterialization used in selected cases of hemorrhoids where the main symptom is bleeding. It is generally used in cases where surgery is contraindicated due to severe concomitant diseases.

Background: Hemorrhoids are a common disease that is often considered an easy problem to solve. Unfortunately, some particular clinical conditions, including Inflammatory Bowel Diseases (IBD), pregnancy, immunosuppression, coagulopathy, cirrhosis with portal hypertension, and proctitis after radiotherapy, challenge hemorrhoids management and the outcomes. Methods: Research and online contents related to hemorrhoids’ treatment in special conditions are reviewed in order to help colorectal surgeons in daily practice. Results: There are very limited data about the outcomes of hemorrhoids treatment in these subgroups of patients. Patients in pregnancy can be effectively treated with medical therapy, reserving surgical intervention in highly selected and urgent cases. In case of thrombosed haemorrhoids, the excision allows a fast symptoms’ resolution, with a low incidence of recurrence and a long remission interval. In case of immunosuppressed patients, there is no consensus for the best treatment, even in most HIV positive patients, a surgical procedure can be safely proposed when indicated. There is no sufficient data in the literature related to transplanted patients. The surgical treatment of hemorrhoids in patients with IBD, especially Crohn’s Disease, can be unsafe, although there is a paucity of literature on this topic. In case of previous pelvic radiotherapy, it must always be considered that severe complications, like abscesses and fistulas with subsequent pelvic and retroperitoneal sepsis, can occur after surgical treatment of hemorrhoids, so a conservative treatment is advocated. Moreover, caution is recommended in treating patients with coagulopathy, considering possible complications (mostly bleeding) also after outpatient treatments. In case of portal hypertension and cirrhosis, a ‘conservative treatment’ is recommended. Bleeding hemorrhoids can be treated with hemorrhoidectomy when they do not respond to other treatments. Conclusion: International literature is very scant about the treatment of patients affected by hemorrhoids in particular situations. A word of caution and concern even about the indication for minor outpatient procedures must be expressed in these patients, in order to avoid possible life-threatening complications. The first-line treatment is the conservative medical approach associated with the treatment of the primary disease.

Anal post-operative pain is one of the principal issues of surgical treatment of hemorrhoids and remains a distressing problem, for patients and physicians. Recent studies have concluded that appropriate postoperative pain management leads to higher patient satisfaction, earlier mobilization, fewer drug complications, eliminated adverse events, faster recovery, and decreased health care cost. However, despite advances in pain medicine, postoperative pain control remains problematic and remains an important unresolved issue that causes expense and patient dissatisfaction. Therefore, this situation calls for multi-modal pain management, choosing medication, dosing regimens and route of administration in an individualized way to optimize efficacy and minimize adverse effects. Multiple approaches, including pharmacological and surgical interventions, have been used to manage pain after hemorrhoidal surgery. Our aim was to check the latest instruments and strategies available in literature designed to find practical solutions to this challenging problem.

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.

Haemorrhoidal disease (HD) is defined as the symptomatic enlargement and/or distal displacement of anal cushions and is one of the most frequent and ancient anorectal conditions. Bleeding, during or after defecation, is the most common symptom. The color of the blood is typically bright red covering the outer surface of the stools. The severity of HD is based on the degree of the prolapse. There are several excisional surgery treatments. In this review, we describe the most common techniques such as Milligan and Morgan, Parks, Ferguson and Whitehead technique. Despite significant improvements in conservative treatments, excisional haemorrhoidectomy techniques are the most effective treatment for III- and IV degree.

Several minimally invasive surgical procedures have been recently developed to treat hemorrhoids without any excision. About 25 years ago, a non-excisional procedure providing doppler- guided ligation of the hemorrhoidal arteries has been proposed - named “hemorrhoidal dearterialization”. The original technique has been modified over the years, and indications were expanded. In particular, a plication of the redundant and prolapsing mucosa/submucosa of the rectum (named “mucopexy”) has been introduced to treat hemorrhoidal prolapse, without excision of the hemorrhoidal piles. At present, the THD® Doppler procedure is one of the most used techniques to treat hemorrhoids. Aim of this technique is to realize a target dearterialization, using a Doppler probe with the final purpose to reduce the arterial overflow to the hemorrhoidal piles. In the case of associated hemorrhoidal prolapse, a mucopexy is performed together with Doppler-guided dearterialization. The entity and circumferential extension of the hemorrhoidal prolapse guide the mucopexy, which can be considered tailored to a single patient; the dearterialization should be considered mandatory. Advantages of this surgical technique are the absence of serious and life-threatening postoperative events, chronic complications, and limited recurrence risks. The impact of the procedure on the anorectal physiology is negligible. However, careful postoperative management is mandatory to avoid complications and to guarantee an improved long-term outcome. Therefore, regular physiologic bowel movements, excessive strain at the defecation and strong physical activity are advisable.

Background: Hemorrhoidal disease is still one of the most prevalent proctological diseases. Pain is the most common complication after surgery but bleeding, urinary retention and perianal infection are also frequent. There is also an important group of patients, such as those with inflammatory bowel disease, pregnancy or immunosuppression, who can present an increased rate or more severe complications. Objective: To describe the complications following different surgical and instrumental techniques for hemorrhoids in a literature review. Special situations were reviewed to determine how they affect the management of the disease. Methods: During August 2019, a narrative review of hemorrhoid surgery complications and special situations was performed using the Pubmed MESH DATABASE. Conclusion: Pain, urinary retention and bleeding remain the most frequent complications after surgery for hemorrhoids; however, special situations must be taken into account in order to choose the best technique to prevent more severe complications.

Background: Haemorrhoidal Disease (HD) is a frequent anal disorder and one of the most common findings identified at the colorectal clinic. This article aims to provide an overview of the anatomy, physiology and pathophysiology of haemorrhoids and haemorrhoidal disease. Introduction: Internal haemorrhoids are vascular cushions located in the anal canal, above the dentate line and covered by columnar epithelium. They contribute to the faecal continence and the sensitivity of the anal canal. The enlargement and/or sliding of haemorrhoidal tissue produce symptoms and complications, the so-called haemorrhoidal disease. Methods: A systematic research was realized, looking at the best evidence in literature, searching PubMed, Embase, Cochrane library and the most renowed textbooks of colorectal surgery from January 1980 to January 2020. Result: Aetiology and pathophysiology of HD are still controversial, but multifactorial. Disruption of stromal scaffolding, enlargement of vascular component, elevated anal pressure and rectal redundancy represent key events in the development and complications of the disease. Local inflammation may also play a role. Goligher’s classification remains the most widely used. Thorough patient history and examination are paramount to diagnose HD, excluding other anal or colonic pathologies. Conclusion: Several aspects of etiopathogenesis and pathophysiology remain controversial. Further studies are needed to obtain a better understanding of the disease.

Background: Hemorrhoidal disease is very common in western countries and rectal bleeding is the main symptom complained by patients. Nowadays the ultimate goal of treatment is to block the bleeding with minimally-invasive techniques to minimize post-procedural pain. Objective: The aim of this study is to assess the preliminary results of the emborrhoid technique (embolization of the superior rectal arteries branches) as a new tool for the proctologist to treat severe bleeding hemorrhoids causing anemia. Many categories of patients might benefit from this treatment, such as patients not eligible for conventional surgery, patients not responding to conventional treatment and fit patients with severe bleeding who refused endorectal surgical therapy. Methods: From May 2017 to November 2018 a total of 16 patients with chronic rectal bleeding due to hemorrhoids underwent super-selective embolization of the superior rectal arteries at the department of General Surgery in La Spezia, S. Andrea Hospital, Italy. Median age was 59 years. 14 patients were males (87.5%). Results: No post-procedural and short-term complications were observed at maximum follow up (12 months). The reduction of rectal bleeding with improvement of the quality of life was obtained in 14 patients (87.5%). Conclusion: Our study, although small in number, demonstrates that embolization of superior rectal arteries with coils to treat severe bleeding due to hemorrhoids is safe and effective and does not lead to immediate complications.

Background: Hemorrhoids are vascular cushions underlying the distal rectal mucosa and contributing to approximately 15–20% of the resting anal pressure with a complete closure of the anal canal. They can become pathological (hemorrhoidal disease, HD) being the most common cause of painless rectal bleeding during defecation with or without prolapsing anal tissue. The treatment of HD must be tailored to both the severity of disease and patient’s expectation. Methods: A narrative review of all the most relevant papers present on the three major databases (PUBMED, EMBASE and WEB OF SCIENCE) regarding conservative treatment was conducted. Results: Conservative treatment is effective in managing the majority of patients complaining of early stages of the disease. Dietary and lifestyle modifications are the first therapeutic step necessary to achieve a regular defecation with soft stool whereas oral phlebotonic drugs can help to control symptoms. The use of topical medications, particularly during the acute phase or in the post-operative period can also be beneficial for all patients complaining of HD. Conclusion: Despite a large number of available products in the market and the high incidence of HD, very few randomized controlled trials have been carried out and most of the studies are uncontrolled case series. Larger and better designed studies are necessary to establish the real benefit of all types of drugs for the treatment of early stages of HD.

The acute strangulation of internal hemorrhoids and the thrombosis of external hemorrhoids are both debilitating and painful conditions which require immediate treatment in order to minimize morbidity and reduce the length of inactivity. In selected cases, urgent surgical treatment, performed within 72 hours of presentation, prevents the negative economic and psychological effects of a prolonged recovery (which is often the case of conservative management), and limits the necessity for surgical intervention at a later date.

Hemorrhoidal Disease (HD) is widely diffused throughout the general population. The system of classification currently used to categorize this pathology is that of Goligher (1975). Several attempts in literature have been made to refine this classification, but as of yet, no single system has been universally accepted. Some studies, however, have succeeded in identifying specific characteristics, besides morphology, that would be able to aptly define HD. An analysis of the literature, with careful consideration of the scores that have previously been proposed, was performed, with the aim of deepening and stimulating discussion about a possible new definition of HD.

Background: Hemorrhoidal disease represents one of the most common anorectal disorders in the general population. Energy devices, such as LigaSure^TM scalpel, have reshaped the concept of hemorrhoid surgery and in turn, have improved patient outcomes and simplified the work of surgeon. Objective: The study aims to evaluate the outcomes of LigaSure^TM hemorrhoidectomy (LH) analyzing main post-operative complications rate, length of stay, operating time, and time to return to work. Methods: In this monocentric descriptive study, from June 2001 to February 2019, 1454 consecutive patients, treated with LH for grade III and IV hemorrhoids, were analyzed. Complications were classified in early, late, and long-term if they occurred within 1 month, between 1 and 2 months or after 2 months, respectively. Results: 90.2% of patients were treated in day surgery regimen and the mean operating time was 14.3 minutes. The post-operative pain decreased from 3.7 mean VAS on the 1st postoperative day to 0.1 mean VAS on 30th post-operative day. Early complications rate was 2.1%: urinary retention accounted for 1.8% of patients. 0.3%-of patients experienced postoperative bleeding and only one required reoperation. Late complications rate was 5.8%: anal stenosis, incomplete healing, and anal fissure were detected in 3.6%, 1.2%, and 1% of patients, respectively. The long term complications rate was 5.3%: anal fistula, soiling, perianal abscess, and recurrence were identified in 0.2%, 0.1%, 0.3%, and 4.8% of patients, respectively. Conclusion: LH is a safe and fast procedure with a proven minimal complication rate.

Background: Numerous non-drug therapies have emerged in recent years for the prevention and improvement of type 2 diabetes (T2D). However, therapies based on dietary modification and/or microbiota may replace a large part of drug therapies in the coming years. Aim: The aim of the current study was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy. Methods: A total of 55 patients met the criteria and were included in double-blind single center RCT, to receive “Symbiter-Smectite” or placebo for 8-weeks administered as a sachet formulation. The primary outcome was the change in HOMA2-IR and insulin sensitivity (% S). Secondary outcomes were glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response. Results: Combined use of the probiotic mixture with smectite leads to a significant reduction in HOMA2-IR (3.14±0.97 vs 2.79±0.85; #128;=0.009) and improvement in % S (34.65±9.92 vs 39.42±12.78; p=0.011) after 8 weeks of the treatment period. Simultaneously, in the secondary outcome analysis lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β (p=0.004), TNF-α (p=0.008), IL-6 (p=0.005) and IL-8 (p=0.042) were detected. In placebo group, changes were insignificant. Conclusion: Probiotic with smectite due to its absorbent activity and stabilization mucus layer properties can impact the synergistic enhancement of a single effect, which manifested with a significant reduction in IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile as compared to placebo.