The target users of guidelines are coloproctological surgeons, gastroenterologists, general practitioners, nurses, and other medical specialists who treat anoperineal diseases.
The guidelines may be used to inform clinical decisions and standards of care. The guidelines are also intended to inform patients about the possible alternatives for the management of their condition.
Classification and scoring system for HD
HD classifications should meet the need to choose the most suitable therapeutic approach as well as to have shared parameters for trials and guidelines.
Internal hemorrhoids are classified according to the presence and severity of prolapse as in the Goligher Classification [
15].
Unfortunately, the Goligher classification has several limitations, because it does not consider the associated symptoms and their impact on quality of life, the etiopathogenesis of the disease, and specific clinical conditions such as circumferential prolapse or single prolapsed pile.
Therefore, it may not reflect the true severity of the disease and the effect of HD on the patient.
To overcome these limitations, different grading systems have been developed. All the grading systems are patient self-reported assessments focusing on the presence and frequency of different symptoms. Nystrom in 2009 used a five-point-based questionnaire assessing the frequency of pain, discomfort, itching, soiling, and need for manual reduction of hemorrhoids [
11]. The system is easy to use and reproduce and has been successfully validated [
13], but it fails to consider the presence and frequency of prolapse that does not need manual reduction. However, hemorrhoidal prolapse is a very important manifestation of HD and can impact on quality of life. Furthermore, the frequency of the symptoms was divided in four grades including “never”, “less than once a week”, “1–6 times per week”, and “every day”. Other grading systems assessing frequency of symptoms of hemorrhoids, similarly to those assessing severity of other conditions such as fecal incontinence, are based on five grades of frequency including” between never and less than once a week”. Yet, probably, the most important flaw of the Nystrom system is the lack of a score for the quality of life. HD is a benign condition and its severity is not only related to the frequency of its symptoms but rather to how they are perceived by the patient. Indeed, similar symptoms may affect patients’ life style and quality of life in very different ways with a significant variation from patient to patient. For this reason, quality of life should be considered when assessing the severity of HD. In 2011, Giordano et al. presented a similar system [
16]. The severity of hemorrhoidal symptoms was scored using a specifically designed questionnaire assessing five different parameters each one scoring from 0 to 4 points, with zero indicating no symptoms and four daily symptoms or symptoms with every defecation. A score of zero corresponds to the complete absence of hemorrhoidal symptoms, while 20 corresponds to the worst possible symptoms. The five parameters assessed are bleeding, prolapse, need for manual reduction, pain, discomfort, and discharge as one parameter and impact on quality of life. This very simple and intuitive system has been proved useful and effective within clinical trials [
17,
18]. Sodergren et al. [
10] elaborated a more complex dedicated scoring system based on symptoms as reported by patients, taking into account how individual symptoms impact on patients’ quality of life. Based on their findings, the most relevant symptoms were selected and scored according to their frequency not in a linear way but according to what their expected impact on patients’ quality of life would be. Very surprisingly, the authors focused strictly on symptoms and the need for manual reduction was not considered. Yet, although strictly speaking this may not be a symptom, it is certainly an important sign of severity of HD and its frequency can impact on quality of life. While the work done by Sodergren and colleagues is very interesting and provides useful information about how this condition affects patients quality of life, it was validated on a small sample size
(n =
45) and it is not tailored to individual patients. It takes for granted that all patients suffering with HD are affected in the same way by each individual symptom, but this may not be necessarily always the case. Furthermore, because the score for each symptom is not linear, the system is not very easy to memorise and could be difficult to use in everyday practice.
Recently, Havard et al. [
12] modified the Nystrom score considering how often the patient experiences prolapse instead of the need of manual reduction. Furthermore, they adapted the Short Health Scale (SHS), previously used in patients with inflammatory bowel disease (IBD) [
19], to HD. This system remains very faithful to the Goligher classification while considering the quality of life using the SHS.
Apart from the previously mentioned system, some authors have proposed other classification [
20‐
22] that are not widely used, due to their complexity.
Diagnosis
Diagnosis should focus on a related medical history for specific symptoms and risk factors corroborated by physical examination suggestive of HD
(Level of evidence: 1; Grade of recommendation: C).
Diagnosis of HD should start with the collection of medical history identifying symptoms suggestive of the disease and risk factors such as constipation, a low fiber diet, sedentary lifestyle, and pregnancy. History of longstanding or uncontrolled portal hypertension should be considered for differentiate HD from anorectal varices [
23]. Moreover, history of IBD and symptoms related to impaired anal continence should be investigated to plan the most appropriate treatment.
Physical examination should confirm the presence of HD ruling out other anorectal diseases. It should include inspection of the perianal tissues, anorectal digital examination, and the evaluation of hemorrhoidal prolapse degree during straining. The anorectal mucosa should be examined with an anoscope. The Sims position should be preferred because less embarrassing for the patient than prone position.
Patients with HD and rectal bleeding should undergo colonoscopy to rule out other colorectal diseases
(Level of evidence: 1; Grade of recommendation: B)
In Western countries, HD is one of the most frequent causes of severe acute lower gastrointestinal bleeding [
8,
9]. Nevertheless, rectal bleeding is a common early symptom of colorectal cancer [
24], as well as of other colorectal diseases such as IBD, diverticular disease, and angiodysplasia. For this reason, patients with rectal bleeding should undergo colonoscopy to rule out these diseases.
Colonoscopy should be mandatory in older patients and when there is a personal and/or a family history of colorectal neoplasms or documented advanced adenoma, IBD, history of altered bowel habits, recent significant weight loss, and a laboratory findings of iron deficiency anemia or a positive fecal immunochemical test (FIT) and guaiac-based fecal occult blood test (gFOBT) [
25‐
30].
Flexible sigmoidoscopy may be associated with other screening modalities, such as gFOBT or FIT, in patients that are not willing or able to undergo colonoscopy [
31,
32].
Sigmoidoscopy and colonoscopy should be integrated with anoscopy that has proven to have a higher detection rate of perianal pathology [
33,
34].
Although an increased maximum resting anal pressure is a common finding in non-prolapsing hemorrhoids [
35,
36], manometry is not routinely performed for diagnosis. Furthermore, anorectal endosonography is not usually indicated for the diagnosis of HD, but may disclose a thickening of submucosal tissue as well as of the internal or external anal sphincter [
37].
Sclerotherapy
Injection Sclerotherapy (IS) should be used for the treatment of I–II and III-degree HD that fail conservative treatment
(Level of evidence: 1; Grade of recommendation: B)
IS, initially described by Morgan in England in 1869 [
76], is the injection of sclerosing agents at the apex of the internal hemorrhoidal complex, above the dentate line, leading to moderate tissue destruction with scarring, fibrosis, and fixation of the hemorrhoidal tissue. Several sclerosing agents have been described and used [5% phenol in almond oil, aluminum potassium sulfate and tannic acid (ALTA), and 50% dextrose water].
Among these agents, ALTA seems to be the most effective one, even if in low resource countries, 50% dextrose water could be a safe and effective alternative [
77-
85].
Moser et al. [
79] in 2007 introduced foam sclerotherapy with polidocanol 3%. Subsequently, the authors compared, in a randomized, controlled, single-blind, multicenter trial, polidocanol foam with liquid polidocanol in the treatment of I-degree symptomatic HD demonstrating the superiority of the foam, after 12-week-follow-up, regarding success rate after one IS session (58/66 pts 88% vs 44/64 pts 69%;
p = 0.01), number of session required for success [1.08 (± 0.32) vs 1.42 (± 0.64);
p < 0.001), and total amount of injected polidocanol (35 mg (± 10) vs 85 mg (± 38);
p < 0.001). Only one adverse drug reaction (acute prostatitis) was observed in the foam group. After that complication, the authors modified the injection technique placing the first injection at 11 o’clock.
Probably, the low dose of drugs used for the foam injection will lead to a decrease of the complication rate.
Several studies reported a 92–100% improvement in bleeding of patients with II- and III-degree HD with the use of IS [
70,
77,
81,
83]. Resolution of prolapse was reported in 85–94% of patients with II–III-degree hemorrhoids with 5 year follow-up [
70,
77,
81].
Subjective moderate/excellent improvement was reported in 70–92% of patients suffering from III- and IV-degree HD [
81,
84]. Recurrence of prolapse is currently 15% at 1 year in unselected II degree [
81,
86]; meanwhile, the failure rate at 1 year was reported to be, respectively, 25% and 80% in III-degree HD patients treated with ALTA and 5% phenol in almond oil [81, 82].
Patients reported a relatively low rate of postoperative pain (24–49%) [79, 86]: the intra-procedural injection was painful in up to 90% [
81]. Bleeding is rare.
Mucosal ulceration is one of the most frequent complications, reported in 3.6% of patients [
81]. Major complications including impotence, severe acute liver injury, fistula formation [
87], fatal necrotizing fascitis, and abdominal compartment syndrome following sclerotherapy have been reported [
88-
91].
Complications of surgical treatments for HD
1.
Open and closed hemorrhoidectomies have a significantly more severe negative impact in the early postoperative period than stapled, THD, LigaSure™, and Harmonic™ hemorrhoidectomies (Level of evidence: 1; Grade of recommendation: B)
Various studies have shown that the closed and radiofrequency hemorrhoidectomies had significantly more postoperative complications (mainly pain) than the open, stapled, LigaSure™, Harmonic™, and THD procedures. Furthermore, OH and CH were associated with greater operative blood loss and a longer operating time compared with the other surgical techniques. Nevertheless, a low recurrence rate is perceived to be the most important advantage of OH and CH which were found to have a lower recurrence rate than THD and SH. Moreover, the use of energy devices such as LigaSure or Harmonic may reduce complication rate, even if with increased costs [
110]. Overall procedural complication rates of SH ranged from 2 to 68%. However, these complications may typically occur in about 16% of procedures [
147,
173,
174].
The overall complication rates after SH and THD were comparable with no significant differences [
175,
176]. Despite a more favourable postoperative period for SH or THD/DGHAL techniques, some procedure-specific complications have been described, and should be considered during preoperative discussion with the patients regarding indications for surgery.
Early fecal urgency after SH has been reported, with incidence rates of 0—25%, and a median of 8% [
173].
On the other side, postoperative tenesmus was reported in up to 24% of patients and pruritus in up to 15% after DGHAL, especially if mucopexy was contemporary performed [
177].
Several studies described different complication rates following office procedures (such as RBL, sclerotherapy, and infrared coagulation), ranging from 3% to 18.8% [
158,
178]. A review of 39 studies including 8060 patients who had RBL revealed post-banding complications in 14% of the patients, although severe complications are rarely reported [
179].
Urinary retention is one of the most common complications after surgery for HD, with incidence rates of 3–50% with most studies reporting a rate around 15% [
180,
181].
2.
Emergency reoperation may be required in about 2% of patients after a surgical treatment for HD (Level of evidence: 1; Grade of recommendation: B)
Up to 90% of emergency reoperations are needed to stop a postoperative bleeding. Interestingly, most patients will not have an identifiable source of bleeding by the time which they are examined in the operating room. However, these bleeding episodes can be significant and a return to the operating room for a second look may be justified. Intractable pain, hematoma incision, residual hemorrhoidal thrombosis, and sepsis are other possible indications for reoperation.
A network meta-analysis of the trials reporting on reoperation showed that THD/DGHALprocedures were associated with significantly fewer reoperations than open, closed, stapled, and LigaSure™ procedures, in large part due to lower bleeding rate [
110]. However, THD had a higher recurrence rate than open, closed, LigaSure, laser, and radiofrequency hemorrhoidectomy, and therefore, the highest probability of being the worst treatments regards recurrence of hemorrhoids.
3.
Bleeding: fewer people have postoperative bleeding after THD/DGHAL procedures compared with OH or SH (Level of evidence: 2; Grade of recommendation: B)
For conventional hemorrhoidectomy (Milligan–Morgan and Ferguson) and bipolar energy device hemorrhoidectomy (LigaSure), rates of bleeding between 0 and 49% have been reported. Clinically significant bleeding has been reported in 0.3–6% of patients, with an average of around 2%, and need of reintervention between 1–2%, without a significant difference in rates of bleeding between the procedures [
121,
182,
183].
Early bleeding was the most common complication after SH, with the overall rate following the procedure ranging from 0 to 68% (median 7.5%) with < 1% of postoperative bleeding requiring treatment [
176,
184].
Bleeding after Doppler-guided hemorrhoidal dearterialization has been reported to be low (0–22%, median 4.3%); however, this needs to be balanced with the chance of long-term recurrence [
108].
Bleeding after RBL normally occurs between 5 and 14 days after treatment, probably due to the sloughing of the ligated hemorrhoids [
182].
However, when RBL was compared to HAL, recurrence rates (if RBL was repeated), symptom scores, complications (such as postoperative bleeding), quality-of-life score, and continence score were similar, although patients had more pain in the early postoperative period after HAL. HAL was also more expensive and was not found to be cost-effective compared with RBL in terms of incremental cost per quality-adjusted life-year [
14].
4.
Pain: The higher levels of pain related to OH and SH compared to other techniques resulted in a longer hospital stay and a later return to normal activities. A multimodal pain reliever regimen should be used to promote a faster recovery, prevent urinary retention, and improve patient satisfaction (Level of evidence: 1; Grade of recommendation: B)
Compared to excisional hemorrhoidectomy, THD and SH are followed by less postoperative pain. A number of modifications in surgical and postoperative management have been proposed and attempted to reduce the pain, with variable results.
Topical 2% Diltiazem or GTN ointment demonstrated a significant pain reduction in randomized trials [
185].
Lateral sphincterotomy or botulin toxin injection also demonstrated efficacy in reducing postoperative pain, suggesting a possible role of sphincteric spasm in its pathogenesis. However, the risk of developing temporary or permanent anal continence alterations limits the use of sphincterotomy.
The use of oral metronidazole in controlling postoperative pain was recently evaluated in two meta-analysis with conflicting results [
186,
187].
Several other treatments such as mesoglycan [
188] were recently used for pain after hemorrhoidectomy, but further trials are needed to reach agreement.
The reported incidence of postoperative pain ranged from 0 to 38% with a pooled value of 15% after THD procedure [
175].
Pain after SH has been attributed to the involvement of the staple line on the sensitive squamous epithelium of the anoderm, inclusion of smooth muscle, or surrounding anorectal tissue in the scar, and induction by the staple line of an inflammatory response in the rectal ampulla, sphincter or rectal spasm, elevated anal resting pressures, retained staples, fibrosis around the staple line, wound dehiscence, and sepsis. Although chronic pain after SH has been variably reported, it is typically experienced by less than 2% of patients.
Treatment of chronic pain following HD surgery should be targeted to the underlying source. However, it is usually quite difficult to manage and cure, which emphasizes the importance of proper knowledge of the anatomy and careful use of surgical techniques.
Warm sitz baths and non-steroidals therapies can relieve mild pain. Antispasmodics such diazepam or cyclobenzaprine may be added if levator spasm is noted. Post evacuatory pain may be treated with oral nifedipine. Anismus may be treated with botulinum toxin injection. For selected cases, sacral neuromodulation has also been described [
189].
In case of chronic pelvic pain after stapler surgery, the removal of staples or staple line excision has been reported [
106,
190]. However, the evidence of these treatments is low and effectiveness observed only in a low percentage of patients.
Urinary retention after hemorrhoidectomy is often multifactorial, with pain as one of the major issues, causing symptoms through irritation of pelvic nerves and activation of pain-evoked reflexes.
Some risk factors are not modifiable (age, male sex, and type of surgery).
In general, epidural and spinal anesthesia have been associated with higher rates of urinary retention compared with monitored anesthesia care. Opioids or excess intravenous fluid has also been shown to significantly increase the risk of urinary retention. Usually, most problems with urinary retention are self-limited, and will resolve without major intervention. An adequate control of pain is a key point in prevention and treatment. Patients with mild retention are often counseled to sit in a bath of very warm water, filled above the waist. When this is unsuccessful, patients may require bladder catheterization. This may involve intermittent straight catheterization or a temporary indwelling catheter, which can typically be removed after a few days without further testing. Α1 antagonists such as tamsulosin can be helpful, and attempts to minimize opioid intake is also worthwhile [
191].
5.
Life-threatening complications: Although extremely uncommon, life-threatening complications have been reported after every treatment for hemorrhoids. Surgeons providing hemorrhoid treatment should be aware of the potential serious complications and alert to their presenting features (Level of evidence: 1; Grade of recommendation: C)
Severe septic complications have been reported after all types of treatments of hemorrhoids, and their real incidence is probably underestimated.
Complications such as rectal perforation, pelvic sepsis, abdominal peritonitis, pneumo-retroperitoneum or mediastinum, pulmonary septic embolism, liver abscess, and Fournier's gangrene, with several deaths, have been reported [
74,
107,
192,
193].
Several infectious complications have also been reported following office procedures (such as RBL, sclerotherapy, and cryotherapy) including pelvic sepsis, Fournier’s gangrene, liver abscesses, tetanus, and bacterial endocarditis. Deaths due to these infectious complications have been reported too [
158].
Even if surgery is usually considered mandatory after serious septic complications, and colostomy often performed, successful conservative treatments (medical, percutaneous drainage) have been reported in selected cases.
The majority of patients in whom these complications occurred were healthy before surgery, and no predisposing factors had been identified. However, it is well known that digital, surgical, or instrumental manipulation of the rectum is associated with a possible 0–9.5% of transient bacteraemia [
194], often with no clinical effects.
Escherichia coli and Bacteroides are the predominant organisms that cause infection following hemorrhoidectomy. The efficacy of a routine use of prophylactic antibiotics has yet to be proven, although special consideration should be given in immunocompromised patients.
6.
Long-term complications: Anal stenosis, soiling, and alterations of anal continence or residual skin tags have been reported after all the treatments for hemorrhoids, without any significant difference among the surgical treatments (Level of evidence: 1; Grade of recommendation: B)
Complications after hemorrhoid surgery are not always immediate, and can instead take months or years to fully develop. In general, they can be more severe and more difficult to treat than those occurring in the immediate postoperative period.
Fifty-one trials (4793 participants; 11 treatments) reported on the proportion of patients complaining of difficulty voiding owing to outlet obstruction or anal stenosis/stricture at follow-up [
110].
Anal stenosis has been reported after stapled or excisional hemorrhoidectomy in 1–7.5% of cases [
191,
195]. In these patients, the normal pliable anoderm is replaced by scar tissue due to excessive removal of the anoderm and distal rectal or to other factors that interfere with the normal healing process. Concomitant injury of the underlying anal sphincter muscle may also occur and contribute to the functional and anatomical alteration. A functional stenosis, due to muscle hypertonicity, should be considered when planning treatments.
Patients often report straining at defecation, smaller caliber stools, and pain at defecation. Anal stenosis may also lead to fecal impaction and overflow incontinence.
Anal stenosis may be classified, according to the severity of the stricture, as mild, moderate, or severe, but its management is usually determined by the severity of symptoms rather than the degree of stenosis. Mild strictures can often be treated with dietary modifications, stool softeners, or fiber supplements. Digital dilatation or the use of anal dilators can be part of the treatment plan if medical management is not sufficient. Patients with moderate or severe strictures who have failed conservative management usually require surgical intervention. To determine the proper surgical procedure, the degree of involvement of the anoderm and the sphincter muscle complex must be determined. In case of fibrotic anal sphincter, sphincterotomy (unilateral or bilateral) may be considered. On the contrary, patients with stenosis of the anoderm are usually treated with flap (multiple types) or anoplasty, aiming to replace local fibrosis with healthy, elastic tissue [
182]. Flap procedures and sphincteroplasty can be associated, in selected patients, while simple release of a stricture may provide temporary relief of symptoms, but generally should be avoided because of the high rate of recurrence.
Fifty-three trials (3856 participants; 9 treatments) reported on the proportion of patients experiencing soiling or difficulty with hygiene or incontinence at follow-up after different types of treatment for HD [
110].
Incontinence to feces and/or flatus was reported, with an overall incidence rate of 0.1–17.8%. However, whether this complication was transient or permanent was often not clearly specified [
147].
Incontinence after hemorrhoidectomy is usually associated with partial- or full-thickness internal (and occasionally external) anal sphincter injury, but it can occur also with intact sphincters, as the hemorrhoidal cushions are known to provide 15% of the patient’s resting anal tone, and their removal can be functionally disadvantageous. Excision of hemorrhoids with secondary healing may also cause decreased sensitivity and reduced capacity for rectoanal discrimination [
196].
Fecal incontinence can also occur after a procedure for prolapse and HD (reported in up to 5% of patients), and it has been related to a low-placed staple line, to an injury to the internal sphincter due to the large diameter of the circular stapler, or to an alteration of anorectal sensitivity or compliance. In a prospective, randomized trial of 134 patients, de novo fecal incontinence at 1 year was reported in 2.5% of patients who had SH compared with 7.5% of patients who had a Milligan–Morgan hemorrhoidectomy [
197].