New anatomical/clinical-therapeutic classification of haemorrhoids. A prospective study.

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NEW ANATOMICAL/CLINICAL-THERAPEUTIC CLASSIFICATION

OF HAEMORRHOIDS. A PROSPECTIVE STUDY

INDEX

1 INTRODUCTION ...2 1.1 Epidemiology ...2 1.2 Anatomy ...3 1.3 Pathophysiology ...5 1.4 Clinical presentation ...6

1.5 Classification and grading of haemorrhoids ...7

1.6 Diagnosis...9

1.7 Conservative treatment ...11

1.8 Medical treatment ...11

1.9 Non-surgical treatment ...12

1.10 Surgical treatment ...13

2NEW ANATOMICAL/CLINICAL-THERAPEUTIC CLASSIFICATION OF HAEMORRHOIDS. A PROSPECTIVE STUDY ...17

2.1 Introduction ...17

2.2 Materials and methods ...19

2.3 Results ...27

2.4 Discussion ...29

2.5 Conclusions ...31

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1 INTRODUCTION

The haemorrhoidal disease is a very common anorectal condition defined as the symptomatic enlargement and/or distal displacement of anal cushions, which are prominences of anal mucosa formed by loose connective tissue, smooth muscle, arterial and venous vessels.1

1.1 Epidemiology

Haemorrhoids affect millions of people around the world, and represent a major medical and socioeconomic problem.

The exact prevalence of symptomatic haemorrhoids is very difficult to establish, because many sufferers do not seek care for their problems or rely on over-the-counter remedies, whereas others attribute other anorectal symptoms as being a result of haemorrhoids.2-3 As noted in a recent American Gastroenterological Association review, the epidemiology of haemorrhoidal disease has been studied via different tools, each of which has methodological limitations.

Surveys that rely on patient self-reporting are nonspecific, and physician-reported diagnosis or hospital discharge data are not always confirmed. Thus, epidemiologic data can vary widely. Estimates of the prevalence of symptomatic haemorrhoidal disease in the United States range from 10 million people, a 4.4% prevalence rate,4 to a National Center for Health Statistics report of up to 23 million people or 12.8% of U.S. adults.5 Others have reported up to a 30%–40% prevalence rate in the United States.6-7

A recent prospective study of screening colonoscopy patients revealed the presence of haemorrhoids in 38.9%, with 44.7% of those patients suffering from haemorrhoidal symptoms.8 In 2004, the National Institutes of Health noted that the diagnosis of haemorrhoids was associated with 3.2 million ambulatory care visits, 306,000 hospitalizations, and 2 million prescriptions in the United States.9

Although it has been stated that 50% of the population will experience symptomatic haemorrhoidal disease at some point in their lives,10 the peak incidence of symptomatic disease seems to be between the ages of 45–65 years.

Pregnancy is associated with an increased risk for haemorrhoids, and there is a slightly increased prevalence in women compared with men.11

Haemorrhoids are commonly seen in patients with spinal cord injury. Development of haemorrhoids before the age of 20 is unusual, and the risk is higher for whites than for blacks.4-12-13

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1.2 Anatomy

The rectum, that extends from the terminal sigmoid colon to the anus, is lined by columnar epithelial mucosa innervated by the sympathetic and parasympathetic nervous systems. Its vascular and lymphatic supplies originate from the hypogastric system.

The anal canal, which is approximately 4 cm in length, extends from the anal verge to its junction with the rectum close to the proximal aspect of the levator-sphincter complex. Unlike the rectum, the anus is lined by anoderm, which is a modified and sensitive squamous epithelium richly innervated with somatic sensory nerves, and supplied by the inferior haemorrhoidal system.14

Prior to work in 1975, the rich plexus of blood vessels in the anal submucosal layer was through to form a continuous ring of erectile tissue around the anal canal.15

Thompson used both anatomic dissections along with radiologic and vascular studies to best elucidate haemorrhoidal anatomy. He was the first to introduce the concept of anal cushions, usually 3 in number, found in the left lateral, right anterior and right posterior positions (or classical 3, 7 and 11 o’clock positions).16

The dentate line is the point at which the squamous anoderm meets the columnar mucosa and tipically lies about 3 cm above the anal verge. The dentate line is the major anatomic reference point when considering the treatment of haemorrhoids. The dentate line differentiates external and internal haemorrhoids. External haemorrhoids are located below the dentate line and drain via the inferior rectal veins into the pudendal vessels and then into the internal iliac vein.12

These vascular cushions are made up of elastic connective tissue and smooth muscle, but since some do not contain muscular walls, these cushions may be considered sinusoids instead of arteries or veins.12

The haemorrhoidal cushions receive their blood supply primarily from the superior haemorrhoidal artery as well as branches of the middle haemorrhoidal arteries; however, there is some communications with the inferior haemorrhoidal arteries as well. The venous drainage is provided by the superior, middle, and inferior haemorrhoidal vessels, allowing the communication between the portal and systemic circulations. These vessels form direct arterial-venous communications within the cushions, and for these reasons, haemorrhoidal bleeding is arterial in nature rather than venous.1

The internal anal sphincter is not solely responsible for the closure of the anal canal. The ability of the anal cushions to alter their volume through their vascular component allows for both the preservation of continence and passage of stool.17

Haemorrhoids play a significant physiologic role in protecting the anal sphincter muscles and augment closure of the anal canal during moments of increased abdominal pressure (e.g.,

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coughing, sneezing) to prevent incontinence and contribute 15 to 20% of the resting anal canal pressure. This tissue is also thought to help differentiate stool, liquid, and gas in the anal canal.17

These vessels are covered by anoderm that is comprised of modified squamous epithelium, and, as a result, these tissues contain pain fibers. Internal haemorrhoids lie above the dentate line and are covered by columnar cells that have visceral innervations. These drain via the middle rectal veins into the internal iliac vessels.

The mucosa of the anal canal that extends above the dentate line adheres loosely to the underlying muscle (internal sphincter). Interposing between the two structures there is the submucosal space that contains the internal haemorrhoidal plexus.18

This space is limited below by the suspensory ligament of Parks that is located at the halfway down the anal canal and it is composed by fibers which comes from the internal sphincter and the muscularis mucosae. It is set at the level of the crypts causing a strong anchored to the surface muscle.18

This layer is thought to be central to the understanding of both the aetiology and the treatment of haemorrhoids. With time and aging, starting as early at the second or third decade of life, this supporting tissue can deteriorate or weaken, leading to distal displacement of the cushions. This may result in venous distension, erosion, bleeding, thrombosis and tissue prolapse.18

According to Parks interpretation, the mucosal suspensory ligament separates the submucosal space above, containing the internal hemorrhoidal plexus, from perianal space below, containing the external hemorrhoidal plexus. It is limited inferiorly by ad muscle longitudinal joint to skin lining the anal margin.19

At the anal verge, the inferior plexus can become engorged in continuity with the internal plexus, giving an external component to the haemorrhoids.20

A careful distinction between prolapsing internal haemorrhoids, and external haemorrhoids and their skin tag remnants may have implication for choice of treatment. 20

From a morphological point of view, regardless of the pathophysiological cause and the clinical manifestations, haemorrhoids have different structural features that may indicate the correct therapeutic approach.

In order to clearly describe the possible forms of anatomical presentation we distinguish haemorrhoids in external and internal presentation.

Possible external anatomical forms of presentation are: prolapse of the internal piles (symmetrical or asymmetrical, with normal or thrombosed or edematous piles), external piles (symmetrical or asymmetrical, thrombosed, or edematous), skin tags and mixed forms.

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Possible internal anatomical forms of presentations are: piles with well detectable peduncle, circumferential prolapse and asymmetrical prolapse.

Acute clinical presentations such as thrombosis of the external or the internal piles, congestion and/or edema and skin tags are anatomical conditions which, due to the significant anatomical changes, must necessarily be re-evaluated after the acute problem resolution in order to properly establish the correct form of classification and the correct surgical approach.

1.3 Pathophysiology

Although haemorrhoidal cushions are normal anatomic structures, they are infrequently referred to until issues arise, and then the term haemorrhoid is meant as a pathologic process.21

The exact pathophysiology of haemorrhoidal development is poorly understood.

The vascular anatomy of the anal cushions inspired many of the original theories of haemorrhoidal aetiology. The suggestion that a local increase in pressure caused venous dilatations within the anal cushions was initially favoured. It appeared to explain the known association between pregnancy and haemorrhoids, and constipation and straining as aeziology.22

The absence of valves in the portal venous system and the portosystemic anastomosis within the anal canal lent support to a venous pressure theory. For years the theory of varicose veins, which postulated that hemorrhoids were caused by varicose veins in the anal canal, had been popular. Now this theory is considered obsolete because haemorrhoids and anorectal varices are proven to be distinct entities. In fact, patients with portal hypertension and varices do not have an increased incidence of haemorrhoids.22

Regarding the study of morphology and hemodynamic of the anal cushions and haemorrhoids, Aigner et al. found that the terminal branches of the superior rectal artery supplying the anal cushions in patients with haemorrhoids had a significantly larger diameter, greater blood flow, higher peak velocity and acceleration velocity, compared to those of healthy volunteers.23

Moreover, an increase in arterial calibre and flow was well correlated with the grades of haemorrhoids. These abnormal findings still remained after surgical removal of the haemorrhoids, confirming the association between hypervascularization and the development of haemorrhoids.23

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Despite their vascular appearance and tendency to bleed, the development of haemorrhoids may be due to a connective tissue disorder. Histologically, the connective tissue fibres of the submucosal layer anchor the anal cushions to the underlying internal sphincter and conjoined longitudinal muscle.24

On the basis of these findings the theory of sliding anal canal lining is quite widely accepted. This proposes that haemorrhoids develop when the supporting tissues of the anal cushions disintegrate or deteriorate.

Haemorrhoids are therefore the pathological term to describe the abnormal downward displacement of the anal cushions causing venous dilatation.24

Other authors, on the hypothesis of a degeneration of the supportive connective tissue, basing on the Oxford theory, proposed that the haemorrhoidal prolapse is a consequence of an internal rectal prolapse. This theory, that is widely accepted, is known as “unitary prolapse theory”. Since the introduction by Antonio Longo in 1998 of the stapled haemorrhoidopexy (PPH), that excise a ring of redundant rectal mucosa proximal to haemorrhoids and resuspend the haemorrhoids back within the anal canal, the world of proctologist surgeons is divided between those who accept that theory and those who distinguished physiopathologically haemorrhoids from rectal prolapse.25-26-27 The lack of uniformity on the real aetiology of haemorrhoids has important implications for surgical treatment.

In our opinion, there are different types of prolapsing haemorrhoids not only from a morphological point of view but also of different etiological origins. Some clinical conditions are characterized by the presence of a recto-anal intussusceptions that causes haemorrhoidal prolapse. In contrast, there are some anatomical presentations in which haemorrhoids, although prolapsing, appear to result from an eversion mechanism that solely involves the anal canal.

1.4 Clinical presentation

The anal cushions of patients with haemorrhoidal disease show significant pathological changes. These changes include abnormal venous dilatation, vascular thrombosis, degenerative process in the collagen fibers and fibroelastic tissues, distortion and rupture of the anal subepithelial muscle.

In addition to the above findings, a severe inflammatory reaction involving the vascular wall and surrounding connective tissue has been demonstrated in haemorrhoidal specimens, with associated mucosal ulceration, ischemia and thrombosis.28

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The most common manifestation of haemorrhoids is painless rectal bleeding associated with bowel movement, described by patients as blood drops into toilet bowl.

The blood is typically bright red as haemorrhoidal tissue has direct arteriovenous communications. Positive faecal occult blood or anemia should not be attributed to haemorrhoids until the colon is adequately evaluated especially when the bleeding is atypical for haemorrhoids, when no source of bleeding is evident on anorectal examination, or when the patient has significant risk factors for colorectal neoplasia.29

For anal bleeding to occur, there must be some disruption of the mucosa and underlying blood vessels. In view of intermittent nature of the bleeding, most often associated with defecation, traumatic forces must be implicated in aetiology.

The rich capillary bed immediately deep to the mucosa may be the source in those patients with general congestion at the level of the dentate line. The contribution of a possible inflammatory process within the pile leading to thrombosis, ischemia, and bleeding is unclear, but suggestive of a previous or ongoing secondary event.30

If it is accepted that bleeding associated with larger haemorrhoids arises from the low pressure vascular sinusoids, this would also explain why the bleeding, although sometimes profuse, ceases once piles are reduced back into the anal canal, where they are subject to compression by the anal sphincters.30

Prolapsing haemorrhoids may cause perineal irritation or anal itching due to mucous secretion from the caudally displaced rectal mucosa or faecal soiling. A feeling of incomplete evacuation or rectal fullness is also reported in patients with large haemorrhoids. Burning and perianal dermatitis can occur frequently. Pain is not usually caused by the haemorrhoids themselves unless thrombosis has occurred, particularly in an external haemorrhoid or if a fourth-degree internal haemorrhoid becomes strangulated. Anal fissure and perianal abscess are more common causes of anal pain in haemorrhoidal patients.30 The correlation between the symptoms related to symptomatic anal cushions and the appearance of the haemorrhoids is poor.

Apparently severe looking haemorrhoids can cause relatively few symptoms. By contrast, normal looking anal cushions can give rise to symptoms which cause great anxiety. Socioeconomic, cultural and educational factors all have a role to play.

1.5 Classification and grading of haemorrhoids

An haemorrhoid classification system is useful not only to help in choosing between treatments, but also to allow the comparison of therapeutic outcomes among them.

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Haemorrhoids are generally classified on the basis of their location and degree of prolapse. Internal haemorrhoids originate from the inferior haemorrhoidal venous plexus above the dentate line are covered by mucosa, while external haemorrhoids are dilated venules of this plexus located below the dentate line and are covered with squamous epithelium.24

One of the most used classification is certainly the Goligher’s classification.31-32

In this classification, internal haemorrhoids, for practical purposes, are classified in grades based on their appearance and degree of prolapse: first-degree haemorrhoids (grade I): the anal cushions bleed but do not prolapse; second-degree haemorrhoids (grade II): the anal cushions prolapse through the anus on straining but reduce spontaneously; third-degree haemorrhoids (grade III): the anal cushions prolapse through the anus on straining or exertion and require manual replacement into the anal canal; fourth-degree haemorrhoids (grade IV): the prolapse stays out at all times and it is irreducible. Acutely thrombosed, incarcerated internal haemorrhoids involving circumferential rectal mucosal prolapse are also fourth-degree haemorrhoids.29

This classification seems to contain some limitations. Not all symptomatic haemorrhoids bleed and the cutaneous components (which may also be symptomatic) are not incorporated into the classification. Furthermore there is also a lack of quantification of prolapse dimension, type of symptoms and its frequency and any possible comorbidities.

These failings do not necessarily invalidate use of this classification, but it not appear useful for the treatment choice.

All the classification of haemorrhoidal disease originate from the need to measure in the best possible way the signs and symptoms indicating at the same time the influence that this disease has on quality of life.

A symptom based classification, attractive for application to comparative studies of the efficacy of treatment modalities, needs to be sufficiently comprehensive to incorporate most the principal symptoms that may be attributable to haemorrhoids.30

Such a classification would be unwieldy and prone to observer error. It would also suffer from the fact that some symptoms may not in fact derive from the haemorrhoids themselves, and that for instance bleeding, often a marked feature of “early” haemorrhoids may be absent or of minor degree in “late” haemorrhoids.30

Classification based upon clinical findings on examination is attractive in the sense that such findings have an influence on management strategy, but suffers the drawbacks that appearances in an individual may change without any specific intervention (especially when prolapse is not a feature), and that treatment efficacy is based upon symptom amelioration rather than restoration of normal anatomy.30

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Some authors proposed classifications based on anatomical findings of haemorrhoidal position, described as primary (at the typical three sites of anal cushions), secondary (between the anal cushions), or circumferential, and based on symptoms described as prolapsing and non-prolapsing.

The degree of prolapse may be recorded as absent, below the level of the dentate line at rest or on straining, or visible at the anal margin at rest or on straining. There may or may not be associated to mucosal (non haemorrhoidal) prolapse.

The state of the anal verge (presence or absence of skin tags, external haemorrhoidal plexus congestion) may be considered. However these classifications are in less widespread use.30 Other authors have recently proposed a classification based on the characteristics of each haemorrhoidal piles called Single Pile Haemorrhoid Classification (SPHC).

This classification considers the number of pathological piles (N), the characteristics of each internal pile and the characteristics of each external pile, reporting the presence of a fibrous inelastic redundant pile (F), the presence of the subversion of dentate line or the congestion of the external pile (E) and the presence of not tolerated skin tags (S).33

Some authors have tried to classify haemorrhoid disease with scores, as P.A.T.E. 2001 and P.A.T.E. 2006, proposing complex classifications in which the examiner has to consider more elements and features: localization of pathological piles, percentage of involvement and localization of skin tags, the basal tone of the internal sphincter, the presence of acute clinical symptoms such as pain, sting, itching and bleeding, haemorrhoidal edema or thrombosis, quality of life. All these features are evaluated with numerical scores and the final score correlates with the most appropriate type of treatment, surgical or medical.34-35 According to the Literature, there’s not a complete classification of the haemorrhoidal disease.

All the classifications proposed over the years, including Goligher classification, fail to find a strong correlation between anatomical and clinical features and the suggested treatment.

1.6 Diagnosis

The definite diagnosis of haemorrhoidal disease is based on a precise patient history and a careful clinical examination. A detailed history is mandatory in patients presenting with symptoms consistent with haemorrhoidal disease, not only to define the degree of the disease, but also to investigate any further symptoms that can orient the examiner to different diagnoses. Patient’s history may also highlight pathologies or paraphysiological mechanisms that may in turn influence the choice of a correct therapeutic approach.

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Significant anal pain could come from other entities, and in this regard the timing of the pain is important. Acute onset pain associated with perianal swelling suggests a thrombosed external haemorrhoid, but pain on defecation typically indicates the presence of a coexistent anal fissure, which can be found in up to 20% of haemorrhoid patients.36

Additional informations that may be of importance include the relationship between symptoms and defecation and a description of factors that might either relieve or exacerbate a patient’s symptoms.

There may be value in finding out how often a patient defecates, whether constipation or diarrhea is an issue, how much time they spend at the toilet, and whether they must manually reduce their haemorrhoids after defecation. It is also important to ask about soiling or incontinence because many patients may be esitant to discuss this.

Rectal bleeding should never be assumed to be from haemorrhoids without at least some type of visual examination.

Depending on the patient’s age, history, presence of alarm symptoms and risk of colon cancer, over digital rectal examination and anoscopy, further examinations such as flexible sigmoidoscopy or colonscopy should be performed.37

Assessment should include a digital examination and anoscopy. The examination is classically performed in the prone or in the left lateral decubitus position, but generally the left lateral position is preferred because it is more comfortable for patients and typically less intimidating than the prone or prone jack-knife positions.

The perianal area should be inspected for any external abnormalities such as anal skin tags, external haemorrhoid, perianal dermatitis from anal discharge or faecal soiling, fistula-in-ano and anal fissure. Some physicians prefer patients sitting and straining in the squatting position to watch for the prolapse.

The digital rectal examination will detect abnormal anorectal mass, areas of induration, anal fissure, anal stenosis and scar, evaluate anal sphincter tone and the movements of the puborectalis muscle, determine the status of prostatic hypertrophy and evaluate possible origins of fistula.

Anoscopy is the most accurate method for examining the anal canal and the distal-most rectum. With the availability of inexpensive disposable anoscopes, the procedure may be performed in the office on unprepared patients quickly, safely, and with minimum patient discomfort.

This diagnostic technique allows to evaluate haemorrhoidal size and location, severity of inflammation, bleeding, recto-anal intussusception, possible associated diseases.

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Further investigations such as ano-rectal manometry, defeco-RM, three-dimensional transanal ultrasound (360°) or endoscopic procedures are performed in case of differential diagnosis or suspected associated diseases.

1.7 Conservative treatment

The first therapeutic attitude in patients with most anorectal disorders, including those with haemorrhoids, is represented by dietary and lifestyle modifications. These measures may in certain cases be sufficient to ensure a significant clinical improvement.

Since shearing action of passing hard stool on the anal mucosa may cause damage to the anal cushions and lead to symptomatic haemorrhoids, typical recommendations include increasing fiber intake or providing added bulk in the diet might help eliminate straining during defecation. As noted in a recent guideline by the American Society of Colon and Rectal Surgeons (ASCRS), a Cochrane analysis of increased fiber intake in 378 patients assessed in 7 randomized trials demonstrated benefit in both symptomatic haemorrhoid prolapse and haemorrhoidal bleeding.37

Lifestyle modification should also be advised to any patients with any degree of haemorrhoids as a part of treatment and as a preventive measure. These changes include increasing dietary fiber intake and oral fluids, reducing consumption of fat, having regular exercise, improving anal hygiene using soothing baths several times per day, abstaining from straining or minimizing time on toilet during defecation, and avoiding medication that causes constipation or diarrhea.37

1.8 Medical treatment

Medical treatment of haemorrhoidal disease described in literature can be broadly divided into oral and topical treatments.

Oral medications are represented by flavonoids and calcium dobesilate.

The oral flavonoids are venotonic agents first described in the treatment of chronic venous insufficiency and edema. They appeared to be capable of increasing vascular tone, reducing venous capacity, decreasing capillary permeability, and facilitating lymphatic drainage as well as having anti-inflammatory effects. 38

Micronized purified flavonoid fraction (MPFF), consisting of 90% diosmin and 10% hesperidin, is the most common flavonoid used in clinical treatment. Some investigators

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reported that MPFF can reduce rectal discomfort, pain and secondary haemorrhage following haemorrhoidectomy. 39

Another venotonic drug commonly used is oral calcium dobesilate for the demonstrated ability to decrease capillary permeability, inhibit platet aggregation and improve blood viscosity, resulting in reduction of tissue edema.40

The primary objective of most topical treatment aims to control the symptoms rather than cure the disease. Strong evidence supporting the true efficacy of these drugs is lacking. These topical medications can contain various ingredients such as local anesthesia, corticosteroids, antibiotics and anti-inflammatory drugs.

1.9 Non-surgical treatment

There are three goals of all non-surgical haemorrhoid therapies: to decrease haemorrhoid vascularity, to reduce redundant tissue, to promote haemorrhoid fixation to the rectal wall.

Rubber band ligation:

although some type of ligation probably dates back to the time of Hippocrates, Blaisdell first described the ligation technique in detail in 1958 by using a pre-tied silk suture. Barron then described the ligation of haemorrhoids by using rubber bands in 1963. Ligation of the hemorrhoidal tissue with a rubber band causes ischemic necrosis and scarring; the resultant inflammatory reaction causes refixation of the mucosa to the underlying tissue, helping to eliminate hemorrhoidal prolapse and with a return of the hemorrhoidal cushions to a normal size and configuration. Placement of rubber band too close to the dentate line may cause severe pain due to the presence of somatic nerve afferents and requires immediate removal. The risk of complications is low, reported in 1-3% 37 to 7% 41

of patients. The long-term success rates range from 50% to 80% 37 considering the overall recurrence (49%) and patient-reported recurrence (29%) with need of further surgical treatment in 32% of the cases. 41

The most common complications is pain or rectal discomfort. Other complications include minor bleeding, urinary retention, thrombosed external haemorrhoids and, extremely rare, pelvic sepsis.

Cryotherapy:

this technique of ablating the haemorrhoidal mass with a freezing “cryoprobe” enjoyed popularity some decades ago but has currently fallen out of favour because of mixed results and complications such as pain and discharge.

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Infrared coagulation (IRC):

the infrared coagulation produces infrared radiation which coagulates tissue and evaporates water in the cell, causing shrinkage of the haemorrhoid mass. IRC for the thermal ablation of haemorrhoids was first introduced by Neiger in 1977. Varying the optical wavelength of the coagulator or the contact time varies depth of penetration into the tissues. The infrared coagulator gun is set to between 1.0 and 1.5 s. Through a proctoscope the base of the haemorrhoid is identified in the same way as for sclerotherapy. Three areas of coagulation are recommended at the base in a triangular shape. IRC creates a constant depth of necrosis. The necrotic tissue is seen as a white spot after the procedure and eventually heals with fibrosis with associated shrinkage of the haemorrhoidal mass. Compared with injection treatments, it is less technique-dependent and avoids the potential complications of misplaced sclerosing injection.42

Sclerotherapy:

injection of a caustic agent into the submucosal layer of the haemorrhoids results in diminished vascularity, intravascular thrombosis, and fibrosis. The fibrosis is also believed to result in tissue fixation and diminish prolapsed as well.

The most popular sclerosant is 5% phenol in almond oil, and if administrated correctly into the base of each haemorrhoid in turn above the dentate line, it should cause minimal discomfort. Injection sclerotherapy can stop bleeding from haemorrhoids, but is unhelpful in treatment prolapsed. It has the advantage that is cheap, easily taught, virtually painless and relatively safe.

Its disadvantage is the high failure rate, and the apparent need for further treatment. Complications of sclerotherapy are rare, but usually result from an injection placed too deeply, especially anteriorly in the male. Urinary retention, prostatic abscess, epididymo-orchitis have all been reported.42

1.10 Surgical treatment

An operation is indicated when non-operative approaches have failed or complications have occurred. A unique treatment of hemorrhoids does not exist; it depends on different philosophies regarding the pathogenesis of the disease, the anatomical presentation, by any comorbidity of the patients and, especially, the experience of the surgeon.

Haemorrhoidectomy:

the surgical excision of haemorrhoids has been popular for centuries. Until the development of the stapled haemorrhoidopexy at the end of the 20th century, surgical excision and its variants were the only options for the treatment of prolapsed haemorrhoids which had failed to respond to less radical measures.

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Various approaches are described and are based on the same theory that blood flow is reduced and the excess tissue is excised.

The two most frequently utilized surgical procedures are the open Milligan-Morgan haemorrhoidectomy and the closed Ferguson haemorrhoidectomy.

In the Ferguson approach, the haemorrhoid is elevated, the external skin and anoderm involved are incised. The haemorrhoid is dissected off the sphincter mechanism and excised. In the Ferguson procedure, the peduncle is ligated and the wound closed with a running suture, on contrary in Milligan-Morgan approach the haemorrhoid is similarly excised, but the wound is left open to epithelialize.

Milligan and Morgan wrote their classic paper on open haemorrhoidectomy, an excision-ligation procedure for haemorrhoids, in 1937.43 This has been subject to numerous modifications over the years and more recently adapted by the use of new and ever more efficient surgical instruments such as diathermy or vascular-sealing device as Ligasure (Covidien, US) and Harmonic scalpel (Ethicon Endosurgery, US).

However, the increased operative cost with these instruments along with lack of long-term results demonstrating superiority of these instruments over traditional scissor excision makes justification for their use difficult.44

Excisional hemorrhoidectomy can be performed safely under perianal anesthetic infiltration as an ambulatory surgery.

A major disadvantage of this procedure is the post-operative pain. A recent Cochrane Review demonstrates that Ligasure haemorrhoidectomy resulted in shorter operative time, less postoperative pain, and shorter convalescence period when compared to conventional haemorrhoidectomy.45

Other operative complications include: acute urinary retention (2%-36%), post-operative bleeding (0.03%-6%), bacteremia and septic complications (0.5%-5.5%), wound breakdown, unhealed wound, loss of anal sensation, mucosa prolapse, anal stricture (0%-6%), that in our clinical experience we try to avoid using anal dilators during the post-operative healing period, and even faecal incontinence (2%-12%).

Closed or open haemorrhoidectomy is considered the most effective treatment modality with a success rate of 95% of cases; despite the success rate so high some Authors reported patients' long-term postoperative complaints such as tissue prolapse/protrusion from the anal canal (27%), rectal bleeding (23%) hygiene issues / itching (18%), anal pain (14%), difficult evacuation (10%), anal stricture (7%) and urination problems (1%).46

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Doppler-guided haemorrhoidal artery ligation

: a new technique based on doppler-guided ligation of the terminal branches of the superior haemorrhoidal artery was introduced in 1995 as an alternative to haemorrhoidectomy.47

Doppler guided transanal haemorrhoid artery ligation is felt to reduce the arterial inflow from the superior haemorrhoid arteries with preservation of the haemorrhoid. It uses a specially designed proctoscope with a Doppler probe and light source to identify the arteries to suture ligate. Frequently, up to six vascular pedicles are noted instead of the traditional three columns of haemorrhoids.

A running suture begins at the apex of the haemorrhoid pedicle and continues down to the dentate line to ligate the internal haemorrhoid. The suture is tied back to the apex to ‘‘lift’’ the haemorrhoid back into its anatomic position.

The overall recurrence rate reported is 30% with a patient-reported recurrence of 29% and need of further surgical treatment in 14%. Possible serious adverse event are reported in 9% of the cases.41

Stapler procedure:

the development of the stapled haemorrhoidopexy (or procedure for prolapsing haemorrhoids – PPH) was the first attempt to deal with the problem of haemorrhoidal prolapse without recourse to excision or ligation of the haemorrhoidal masses.

The purpose of this surgery is to restore normal anatomy repositioning hemorrhoids in their natural position resecting a portion of prolapsing rectal mucosa responsible, according to the fisiophatological unitary prolapse theory, of the haemorrhoidal disease.

This technique was introduced and developed by A. Longo in the 1990th. A circular stapling device is used to excise a ring of redundant rectal mucosa proximal to haemorrhoids and resuspend haemorrhoids back within the anal canal.

Apart from lifting the prolapsing haemorrhoids, blood supply to haemorrhoidal tissue is also interrupted disrupting the branches of the haemorrhoidal artery which feed the anal cushions. Because the excised tissue is proximal to the somatic pain fibers in the anal canal, less postoperative pain is experienced.

Severe complications have been reported including bleeding, incontinence, stenosis, fistula, and perineal sepsis.

In women, great care should be exercised to ensure that vaginal tissue or the rectovaginal septum is not incorporated into the purse-string that may result in a rectovaginal fistula. Other rare complications include perforation, retroperitoneal sepsis, and complete rectal obstruction. Considering the possible serious complications and benignity of the treated disease, the risk/benefit ratio should be carefully evaluated.

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On the basis of the same principle introduced by Longo, over the years, other operations have been proposed with new devices and new technical variants able to ensure the execution of a rectal mucosal resection modulated according to the degree of prolapse. The new technical features of these instruments and the possibility of performing a wider transanal rectal resection allowed to treat haemorrhoids associated with ODS. In this regard have been developed with mixed success, interventions such as STARR with Contour® Transtar ™, DSH and TPS (Tailored Prolapse Surgery Device with High Volume TSTStarr+).

The TSTStarr+ device allows the surgeon to decide the amount of the resection through a intraoperative evaluation, in order to perform a resection for haemorrhoids, ODS or both diseases.

The reported long-term results after circular stapled haemorrhoidopexy are very variables in terms of recurrence or persistence of symptoms such as tissue prolapse or protrusion 46-48 or persistent rectal bleeding 48.

Comparative multicentre and randomised trial refer long-term patient-reported recurrence rates of 42% for stapled haemorrhoidopexy and 25% for traditional excisional surgery; serious adverse events such as bleeding, pain and stenosis was found in 7% of the cases treated with stapled procedures and in 9% in those submitted to traditional haemorrhoidectomy.

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2 NEW ANATOMICAL/CLINICAL-THERAPEUTIC CLASSIFICATION OF

HAEMORRHOIDS. A PROSPECTIVE STUDY

2.1 Introduction

The haemorrhoidal disease is a very common anorectal condition that affects millions of people around the world, and represents a major medical and socioeconomic problem. All publications regarding haemorrhoidal treatment try to demonstrate the superiority of one technique over another, without considering the great heterogeneity of the analyzed groups, which are selected using only the Goligher classification.31-32

Even though it is nowadays the most used, Goligher classification seems to contain some limitations such as lack of a quantification of prolapse dimension, type of symptoms and its frequency and any possible comorbidities.

Therefore this classification does not appear useful for the treatment choice.

Over the years many authors have proposed different classifications, some based exclusively on the symptoms 30, others on the anatomical features 30, others based on scores as PATE 2001 and PATE 2006 34-35, or on a detailed observation of the characteristics of each haemorrhoidal pile 33.

The result are numerous classifications that do not correlate the variability of possible presentations with a suggested therapy.

All these classifications appear to be not useful to improve surgical results. If we consider the results reported in literature in terms of recurrence, post-operative and long-term complications and re-operations rate, there is not even a surgical procedure for haemorrhoids treatment with satisfactory results. 46-48-49

Traditional excisional surgery is both more clinically effective and less costly when compared with stapled haemorrhoidopexy but is significantly more painful in the post-operative period 49.

On the other side stapled procedures and artery ligation with mucopexy are effective in treatment of prolapse and bleeding with less post-operative pain, despite an higher recurrence rate 41.

Indeed, considering all possible surgical and outpatient techniques, their advantages and disadvantages and their best indications, we propose to use the best procedure for each specific group of patients.

For this purpose we need a proper classification which correlate the anatomical and clinical features with the best treatment indication.

18

Therefore in 2013 we created a new anatomical/clinical-therapeutic classification (A/CTC) of haemorrhoids.

The aim of our study was to verify in the observation period 2014-2015 whether, using our classification, we can improve surgical results and reduce the invasiveness of surgery and early and late complications.

19

2.1 Materials and methods

In the period from January 2014 to December 2015 all patients who were candidates for surgical treatment of haemorrhoids were included in our prospective study.

All our patients were evaluated according to our internal protocol for haemorrhoidal disease: a complete clinical evaluation with medical history, clinical examination, and anoscopy. All patients with impaired anal continence or constipation, with previous traumatic delivery or prior proctological surgery were carefully evaluated by anorectal manometry and transanal ultrasound. These patients were included in the study except if the possible associated problem appeared to be a priority.

Patients who referred obstructed defecation syndrome (ODS) underwent further investigations, according to our diagnostic protocols, and excluded from our study in the case in which ODS represented the main reason of the operation.

Whereas the basis of the failure of surgical therapy is often an incorrect choice of treatment, in A/CTC we tried to identify the correct surgical approaches in relation to each group of anatomical and clinical presentation.

In our opinion, the correct surgical technique is considered the one which, in relation to each type of haemorrhoids, offered the best balance between minimally invasive surgery and greater therapeutic efficacy.

The new anatomical/clinical-therapeutic classification (A/CTC) of haemorrhoids first considers the indicated treatments and, in order of importance for the choice of the procedure, the anatomical presentations, any possible contraindications, any associated diseases and the types and the frequency of symptoms.

The possible haemorrhoidal treatments are classified in four groups A, B, C, D (Tab. 1). The three main categories of surgical treatment of haemorrhoids discussed in the literature, and that we perform for years, are haemorrhoidal artery ligation and mucopexy, stapler procedures and hemorrhoidectomy.

Our experience and analysis of literature allowed us to understand in which groups of patients is more indicated a technique in relation to another. We should point out that in a "flexible" attitude that we have always support, techniques can often be partially combined. In our series the overall percentage of combined interventions was 22,3%.

From an anatomical point of view in A/CTC we consider the following anatomical presentations: internal circumferential prolapse, internal asymmetrical prolapse, piles with well detectable peduncle, large external haemorrhoids (Figure 1-2-3).

20

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s (A

/CTC).

G

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1

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R B L, IR C , sc le ro the rapy H em or rhoi da l de ar ter ia li zat ion and m ucope xy , T S T T ai lor ed pr o lap se sur g er y w it h st apl er (PP H, d o u b le P P H, Hig h Vo lu m e) Exci si ona l hem or rhoi d ec tom y

Anatom

y

A bse nt pr o laps e, v er y sm al l pr o lap se Sm al l and a sym m et ri cal pr ol aps e, w el l de tec tab le hem or rhoi d al p ed unc le C ir cum fer ent ia l pr ol aps e ( int raop er at iv e ev al uat ion ) H em or rhoi da l pr ol apse w it h lar g e e x te rna l pi le s

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Sta b le e x te rna l pr ol aps e, int u ss u sc ep ti on Sta b le e x te rna l pr ol apse A nal s teno si s, i m pai red ana l con ti n enc e (abs o lu te) -

Assoc

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d

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isease

- A nal f is tul a, f is sur e , i m pai red ana l con ti n enc e ODS Im pai red ana l con ti n enc e, IB D , ana l f is tul a, f iss ur e, ana l st enos is, coa g ul at io n di so rde rs, a nt icoa g ul ant s and/ o r an ti pl at el et s, im m unot her apy

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B lee d ing , di scha rg e B lee d ing ( m aj o r sy m pt om ), di sc h ar g e, c o nt inen ce d iso rder s Prol apse , bl eedi ng , di sc h ar g e A cut e h ae m or rho ida l ed em a, ac ut e ha em or rh oi d al thr om bosi s, di sc ha rg e

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Fre que nt ly , al w ay s Fre que nt ly , al w ay s Fre que nt ly , al w ay s Som et im es , fr equ ent ly , al w ay s 1

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R e l e v a n c e G r a d i n g

21

Fig 1 Group B: anatomical presentation

22

23

24

Possible contraindications to specific surgical procedures should be considered. Another parameter to consider is any associated disease: obstructed defecation syndrome (ODS), impaired anal continence, inflammatory bowel disorders (IBD), anal fistula, fissure, anal stenosis, coagulation disorders, immunotheraphy, anticoagulants and /or antiplatelets. The symptoms include the presence of prolapse, bleeding, pain, thrombosis, acute haemorrhoidal swelling or external prolapse, and discharge. Symptoms can be significant but rarely present, or otherwise minimal but frequently.

These several clinical manifestations have different impacts on quality of life. For this reason, we consider an essential parameter, within a most possible complete classification, also the frequency of symptom presentation.

To validate A/CTC and verify whether it can improve the surgical results, we evaluated the three surgical groups (B, C, D) of the classification.

The total number of patient was 381 and they were followed with a mean follow-up of 24 months. The total male to female ratio was 1,005 (M= 191; F= 190).

The number of patients in group B was 39 (10,2% of the total), with a male to female ratio of 0,56 (M = 14; F = 25). 3 patients (7%) in group B underwent previous rubber band ligation. The main symptoms reported were bleeding 32/39 (82%), pain 15/39 (38%), burning 2/39 (5%), previous haemorrhoidal thrombosis 5/39 (13%). In 51% of the patients the haemorrhoidal disease was associated to other proctologic diseases.

The main pathologies associated were impaired anal continence (28%), anal fissures (15%), anemia (4%), symptomatic skin tags (4%).

The operations performed were doppler guided dearterialization with mucopexies associated, such as (1) THD (Transanal haemorrhoidal Dearterialization) n = 22/39 (57%) (and (2) HAL-RAR Trilogy (haemorrhoidal Artery Ligation - Recto Anal Repair) n = 6/39 (15%) (Figure 4) and (3) Tissue Selective Therapy stapler n = 11/39 (28%).

In 15,2% of the cases, the operations described above were associated to another operation such as sphincterotomy (7,6%), single haemorrhoidectomy (5,1%) and skin tags excision (2,5%).

The number of patients in group C was 202 (53% of the total), with a male to female ratio of 1 (M = 101; F = 101).

A previous proctologic surgery was observed in 30/202 (15%); the previous operations performed were: haemorrhoidectomy (2,5%), Longo procedure (2,5%), rubber band ligation (8%), and other proctologic surgical procedures for non-haemorrhoidal diseases (2%). The main symptoms reported were prolapse (90%), bleeding (60%), discharge (25%) and pain (10%).

25

In group C, we performed tailored prolapse surgery with stapler (TPS ) using, depending on the prolapse dimensions, (1) High Volume stapler (36mm) n = 106/202 (52,5%) (Figure 4), (2) PPH (33mm) n = 81/202 (40%) and (3) Double PPH stapled haemorrhoidopexy n = 15/202 (7,5%). In 24,7% of the cases, the stapler procedure was associated to other procedure such as partial excision of the external component (14,8%) and skin tags excision (9,9%).

The number of patients in group D was 140 (36,7% of the total), with a male to female ratio of 1,18 (M = 76; F = 64). A previous proctologic surgery was observed in 45/140 (32%); the previous operations performed were: haemorrhoidectomy (7%), HAL-RAR (1,4%), Longo procedure (8%), Criotherapy (1,4%), DSH (0,7%), rubber band ligation (8%), Delorme (0,7%) and other proctologic surgical procedures for non-haemorrhoidal diseases (4,8%). The main symptoms reported were bleeding (76%), pain (42%), burning (9%), previous haemorrhoidal thrombosis or edema (83%).

In 43,5% of the patients the haemorrhoidal disease was associated to other proctologic diseases.

The main pathologies associated were anal fissures (20%), impaired anal continence (12,5%), proctitis (6,4%), anemia (1%), other (3,6%).

The operation performed in all the patients of group D was an excisional haemorrhoidectomy with excision of 3 piles in 68,2% of the cases and 2 piles in 31,8%. In 29/140 patients (20,7%) haemorrhoidectomy was associated to other procedures such as mucopexy (10,8%), fissure treatment (6,4%), fistula treatment (3,5%).

26

Fig. 4 Surgical procedures and devices

27

2.3 Results

The final results were analyzed considering success, re-operation rates and post-operative and long-term complications for each group of the classification. (Tab.2)

Group B: the success rate was 33/39 (85%) with a recurrence rate of 6/39 (15%). The rate of re-operated patients, including those with recurrence, was 1/39 (2,5%).

In 1/39 (2,5%) of the cases, a post-operative complication (bleeding) was observed without need of surgical treatment. No long-term complications were reported.

Group C: The success rate was 184/202 (91,1%) with a recurrence rate of 18/202 (8,9%). The recurrences observed were complete (n=4, 2%) or partial (n=14, 6,9%). The rate of re-operated patients, including those with recurrence, was 8/202 (3,9%).

A post-operative complication was observed in 3,4% of the patients; the complications reported were bleeding in 5/202 of the cases (2,4%), which required in one case (0,5%) a surgical treatment, and hematoma 2/202 (1%) which underwent conservative treatment. The long-term complications reported in 6,9% of the cases were: urgency (4/202, 2%), persistent bleeding (5/202, 2,5%), soiling (3/202, 1,4%), tenesmus (1/202, 0,5%) and painful suture (1/202, 0,5%).

Group D: The success rate was 134/140 (95,7%) with a recurrence rate of 6/140 (4,3%). The recurrences observed were complete (n=1, 0,7%) or partial (n=5, 3,6%).

The rate of re-operated patients, including those with recurrence, was 2/140 (1,4%). A post-operative complication was observed in 9/140 patients (6,4%); the complications reported were bleeding in 8/140 of the cases (5,7%), which required in one case a surgical treatment, and urgency 1/140 (0,7%).

The long-term complications reported in 4/140 cases (2,8%) were: urgency (2/140, 1,4%), stool incontinence (1/140, 0,7%) and soiling (1/140, 0,7%).

28

T

ab

. 2

P

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cal re

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m

ean

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85% 91,1 % 95,7% 92,1 %

P

ost

-op

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2,5% 3,4 % 6,4 % 4,4 %

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0% 6,9 % 2,8% 4,7 %

Re

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2,5% 3,9% 1,4% 2,8 %

29

2.4 Discussion

Nowadays, new techniques in surgical management of haemorrhoids have led to a more critical attitude about the need for a new classification that allows to choose the right treatment for each clinical case.

This is due to the fact that the treatment of haemorrhoidal disease should consider the great heterogeneity of clinical and anatomical presentations.

The current classifications appear to fail to have a strong correlation between anatomical and clinical features and the indicated treatment.

The aim of this study was to propose a complete classification that could fit the clinical practice giving to the surgeon the possibility of choosing the correct treatment.

Several procedures can be performed for haemorrhoids treatment. They can be resumed in four groups: outpatient procedures, haemorrhoidal artery ligation and mucopexy, stapler procedures and haemorrhoidectomy.

The results reported in literature regarding any of these surgical treatment appear to be completely satisfactory.

Patients should receive the best treatment possible which is the procedure that offers, in relation to each specific case, the best balance between minimally invasive surgery and greater therapeutic efficacy.

Therefore, the correct indication is achieved though a proper classification and a correct therapeutic strategy which should consider: the anatomic presentations both pre- and intra-operative, contraindications related to possible comorbidities and the effectiveness of each procedure for specific symptoms.

Sometimes haemorrhoidal conditions considered to be more advanced (Goligher grade IV) have prolapses more mobile and therefore easier to treat than in huge Goligher grade II prolapses. Hence, the anatomical definition of Goligher classification does not appear useful to treatment choice.

Any associated pathologies, which may indicate or contraindicate a certain type of surgery, should be considered.

Symptoms should be evaluated since some clinical manifestations oriented toward one or another procedure. This is due to a specific effectiveness of some treatment for particular symptoms such as haemorrhoidal artery ligation and mucopexy for control hemorrhoidal bleeding 41, stapler procedures to treat prolapse-related symptoms50 and excisional haemorrhoidectomy for recurrent thrombosis and/or complicated external component51. Finally, the frequency of symptoms in order to determine how effectively the haemorrhoidal symptom affects the quality of life, and assess whether and what possible operation is necessary or not.

30

The overall success rates reported for haemorrhoidal artery ligation and mucopexy reaches 89,2% with higher recurrence rate for fourth-degree haemorrhoids (11,1%-59,3%). 52

This procedure showed in reported series to be more effective in controlling haemorrhoidal bleeding (success rate up to 95%53) than in prolapse treatment54. Post-operative complications and long-term complications are reported approximately in 9% 41 and 20% 55 respectively while re-operations rate is 14% 41.

In our study, the patients who underwent doppler-guided dearterialization with mucopexies (group B) have shown a success rate consistent with the literature data, but with significantly lower re-operation rate.

In our series, no long-term complications in group B were reported.

In literature, the success rate after stapled haemorrhoidopexy range from 83,3% to 88,2%. 56 Even though some Authors reported a regression of external piles in 90% of cases at 1 year, that persisted through 2 years in 85% of cases 57, stapler procedures are associated to an higher recurrence/persistence rate of skin tags and large hypertrophic external haemorrhoids than haemorrhoidectomy58.

In group C, in which patients underwent stapler procedure, the success rate (91,1%) was quite high compared to the results of the literature.

The post-operative and long-term complications observed were considerably lower than the literature data.50-59-60-61

Haemorrhoidectomy, which is considered the most effective treatment option, has a success rate reported in literature reaching up to 95%.62; the post-operative complications range from 9% 49 to 25% 46 while re-operations rate is approximately 3% 46.

The success and recurrence rates of patients in group D, 95,7% and 4,3% respectively, were satisfactory compared to the results reported in literature, and with lower post-operative and long-term complications rates, 6,4% and 2,8% respectively.

Despite the results reported in literature, some long-term studies showed worse success rates for haemorrhoidal treatments such as 65% (stapled haemorrhoidopexy) 46, 73% (excisional haemorrhoidectomy) 46, and 70% (THD, not available long-term results) 41.

These results are consistent with our experience considering that 17,8% of the patients in the study had previously underwent surgery for haemorrhoids. This data appears even more significant considering that, in literature, the recurrence rates are usually statistically higher than re-operation rates.

31

2.4 Conclusions

The aim of our prospective study was to verify whether the proposed haemorrhoid classification could improve the surgical results by observing the data obtained in the three surgical groups of A/CTC.

In our study, with a mean follow-up of 24 months, the overall success rate was 92,1%, post-operative complications 4,4%, long-term complications 4,7% and re-operation rate 2,8%. The data related to each surgical technique used in this study were satisfactory compared to the results of the literature.

The observed good results are probably due to a proper selection of patients and a correct surgical indications.

A/CTC showed to ensure the surgeon to choose the best tailored treatment for each specific group of patients and with the best balance between minimally invasive surgery and greater therapeutic efficacy.

In conclusion, the classification we proposed appear to be feasible and useful to improve clinical outcomes and surgical results.

32

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