Rubber band ligation versus haemorrhoidectomy for the treatment of grade II–III haemorrhoids: a systematic review and meta-analysis of randomised controlled trials

Haemorrhoids are one of the most common proctological disorders with an incidence of about 9/1000 patients per year in the Netherlands [1] and a prevalence up to 39% in the general population [2]. Treatment consists initially of conservative measures such as lifestyle advice, diet and toilet behaviour. In addition, there are various surgical options, Haemorrhoidectomy is considered the gold standard and this was recently confirmed in a British trial and systematic review [3, 4]. The most common minimally invasive procedure is rubber band ligation (RBL). Other minimally invasive procedures are sclerotherapy and laser treatment. These treatments are usually reserved for grade I and II haemorrhoids, although RBL is also used for grade III [5, 6]. Grade III and IV haemorrhoids can be treated with open haemorrhoidectomy, semi-closed haemorrhoidectomy, and stapled haemorrhoidectomy with possibly mucopexy or haemorrhoidal artery ligation (HAL).

Many studies and meta-analyses have been published on the subject of haemorrhoid treatment. All these studies focus on groups of comparable surgical procedures. It is common to distinguish between minimally invasive treatment for grade II and III diseases (sclerotherapy and RBL) and surgical procedures for grade III and IV haemorrhoids (haemorrhoidectomy and stapled haemorrhoidectomy). However, the criteria for selecting a minimally invasive treatment versus an operation are not always that evident. There is obviously an overlap in indication, as has become clear from several surveys amongst treating surgeons [7, 8]. There are few trials comparing the clinical outcome of the two most common treatments RBL and haemorrhoidectomy. A systematic review from 2005, updated in 2016, of 3 small heterogeneous trials concluded that RBL leads to a higher recurrence rate, but on the other hand less pain, fewer complications, and a less stressful experience for the patient [9, 10].

It remains unclear which of the two most common procedures is preferable as regards healthcare costs. There are hardly any studies investigating the cost effectiveness of the various treatments. Only 1 study compared costs of stapled haemorrhoidopexy with RBL in grade II haemorrhoids with results in favour of RBL [11]. A recent study from 2016 compared HAL with RBL, with HAL clearly entailing higher costs, even though the analysis includes the possibility of repeated RBL treatments [12]. Since haemorrhoidal disease is a benign condition, the main goal of treatment is the resolution of symptoms and improvement of patient wellbeing. It is, therefore, important to include patient-related outcomes when determining the best treatment.

The aim of this systematic review was to assess the literature on the clinical effectiveness (including patient-related outcomes) and cost effectiveness of RBL versus haemorrhoidectomy in patients with symptomatic grade II and III haemorrhoids.

This systematic review was undertaken in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [13]. To reduce the risk of bias, a study protocol was made at an early stage and stated precise eligibility criteria. The protocol was registered in PROSPERO (registration number CRD42018102000) [14].

A total of 324 references were identified from the relevant electronic searches. Two duplicates were removed. Two hundred and ninety-five studies were excluded after screening titles and abstracts. Twenty-seven full-text studies were assessed for eligibility. Of these, 19 were excluded after full-text review. Eight RCTs were identified and included in the analyses (Fig. 1) [17‐24]. The risk of bias in the included trials is summarised in Fig. 2a, b. The overall methodological quality of these studies was determined to be moderate. The eight trials contained a total of 1208 patients with second- and third-degree haemorrhoids, who underwent RBL or haemorrhoidectomy (608 versus 600, respectively). The characteristics of the studies are shown in Table 1.

The present study gives an update of the results of the two most commonly used strategies in treatment of grade II and III haemorrhoids. The results of this review suggest that haemorrhoidectomy is superior to RBL in reducing symptoms but is associated with more postoperative pain and adverse events. The review included only RCTs. Studies otherwise designed would result in an increase of bias. The overall quality of the included studies based on the Cochrane Collaboration’s risk of bias tool was questionable. Incomplete outcome data (attrition bias) and selective reporting (reporting bias) were the major drawbacks. Furthermore, an important limitation was the lack of or poor definition of outcome measurements. The overall methodological quality of the included studies is moderate. Unfortunately, none of the included studies described the randomisation process and three of the eight studies compared more procedures than the two we were interested in. The included studies did not all use the same techniques of haemorrhoidectomy and RBL applications and only 3 studies reported the length of follow-up which was, respectively, 3, 6 and 12 months [17, 21, 23]. The overall certainty of the evidence using the GRADE system was, therefore, low to very low (Table2). It should be noted that three studies [18, 22, 23] are not of recent date but we still consider these relevant since the surgical procedures discussed have not changed since.

We defined control of haemorrhoidal disease by need for retreatment within 1 year or by self-reported residual complaints. Four studies report on effect of treatment and/or recurrence but a definition or follow-up is not given making results hard to interpret. Three studies only mention effect of treatment on bleeding, prolapse [18, 23] or pruritus [22] while other symptoms of haemorrhoidal disease are not mentioned. This makes it difficult to comment on efficacy of treatment. Other trials reporting on the outcomes of these procedures also demonstrate a lower recurrence rate after haemorrhoidectomy with the same limitations [4, 9, 25]. Besides, should repeated banding be considered as recurrence or part of the treatment? For re-banding, for instance, two or three sessions are common and patients may find this a more agreeable than one operation if the results are comparable in the long run. Except for 2 trials [17, 24], which reported performing 1 session of RBL, none of the included trials describes the exact number of RBL sessions.

Overall, postoperative complications were more common after haemorrhoidectomy. Postoperative bleeding and pain were mentioned in all studies and was more common following haemorrhoidectomy. However, none of the studies defined bleeding and only 1 used a visual analog scale to assess postoperative pain [21]. In addition, the timing of these outcome assessments was not specified in most studies. Pain after RBL has been analysed in other studies comparing RBL with more invasive procedures and was found to be less severe after RBL [12]. In a study by Watson et al. [26], 183 patients were asked to rate their pain on a scale of 1–5 at different time points after RBL. The most severe pain was experienced at 4 h following RBL and after 1 week, 75% of the patients did not experience any pain at all. In the HubBle trial, pain was less after RBL compared to a surgical procedure (HAL) at 1 day (3.4 versus 4.6) and 1 week (1.6 versus 3.1) following the procedure [12]. After 3 and 6 weeks, pain scores were similar in both groups.

Urinary retention occurred far more often after haemorrhoidectomy. Rates of urinary retention are reported in the literature: 2–34% after haemorrhoidectomy and 0–0.4% after RBL [3, 27, 28]. The mechanism responsible for urinary retention is thought to be the triggering of a reflex leading to inhibition of the detrusor muscle. Pain and stretching of the anal canal may induce this reflex. The extent of surgical resection is related to the risk of developing urinary retention, probably due to more postoperative oedema and pain [29].

Anal incontinence following haemorrhoidectomy was reported in 3 studies [18, 20, 22] ranging from 0 to 7.7%. Anal incontinence after RBL was not reported. This is in concordance with the recent literature [30]. However, none of the studies used a validated scoring system for anal incontinence. Other literature using the Vaizey or Cleveland incontinence score mention similar scores for RBL and HAL [12]. Anal stenosis was found in 1 patient after RBL and was not common after haemorrhoidectomy either (26/472) but this difference was significant. This stresses the importance of a careful surgical technique in performing haemorroidectomy which is sometimes is considered simple surgery.

Treatment patients complaining of haemorrhoids aims to improve these symptoms, making quality of life an essential marker of success. Patient satisfaction was similar between the groups but no validated questionnaires were used [20, 23, 24]. The literature on patient satisfaction following haemorrhoidal treatment is scarce. Brown et al. found in a study comparing RBL with HAL found that patient satisfaction after RBL did not differ from HAL in the long term [31].

Murie et al. reported 32 lost days of work after haemorrhoidectomy compared to 3 days after RBL [22]. Time until return to work and normal activities after haemorrhoidectomy has been reported to vary between 9 and 54 days [32]. This wide range can be due to the number of (one-, two-, three-) piles operated or the policy regarding postoperative pain management.

There are numerous studies on treatment of haemorrhoids with various techniques. This illustrates a lack of consensus about when to apply which technique for which symptoms. Treatment for a benign disease like haemorrhoids has to be safe and should be aimed at relieving symptoms. More conservative methods like RBL are reserved for grade II (but also III) haemorrhoids and more invasive surgical methods for grade III (but also II). That leaves a grey area in which the choice of treatment is not so evident. The gold standard for conservative methods is RBL and the gold standard for surgical procedures is haemorrhoidectomy [33]. Studies comparing these two methods are scarce and only 1 systematic review comparing 3 trials on this subject has been published [9].

Reliable outcome measurements relate to the definition of haemorrhoids. The choice of treatment is mostly based on gradation of haemorrhoids usually based on Goligher’s classification [34]. However, symptoms do not reliably relate to Goligher’s classification [35]. Clinical evaluation using only the Goligher scale could cause confusion regarding true symptomatic recurrence or symptom persistence. A more solid definition of failure or recurrence together with a validated score of symptoms is indispensable in evaluating treatment [36].

Van Tol et al. recently analysed outcome measurements used in trials on haemorrhoids [37]. Fifty-nine largely varying outcomes were identified. Based on these, the authors developed four different core areas: symptoms, complications, recurrence and resource use/economical impact. When we consider, these core areas in the analysed trials symptoms are only rarely described. None of the studies used a validated symptom score. Recurrence was reported in four studies and was more common following RBL. Complications (postoperative pain, anal stenosis/incontinence, bleeding and urinary retention) were mentioned in 6 studies. Resource use/economical impact was not addressed in any of the studies.

It is also important to realise that haemorrhoidal disease is currently one of the most common disabilities. The condition often leads to disruption in an individual’s personal and working life. Management has considerable cost implications, and therefore, economic consequences. None of the included trials mentions costs. Future studies should focus not only on and patient satisfaction with treatment but also on the economic impact of treatment.

The results of this review suggest that haemorrhoidectomy offers better symptom control compared with rubber band ligation in patients with grade II–III haemorrhoids, but is accompanied by more postoperative pain and complications. The main conclusion, however, must be that the studies analysed are of poor quality, and therefore, no advice about treatment protocol can be given. Good quality trials with an emphasis on economic and patient-related outcomes are needed. A multicentre randomised trial comparing RBL with haemorrhoidectomy has recently been initiated in the Netherlands.