Abstract
Introduction
Haemorrhoids are cushions of submucosal vascular tissue located in the anal canal starting just proximal to the dentate line. Haemorrhoids are a common condition. The incidence is difficult to ascertain as many people with the condition will never consult a medical practitioner.
Methods and outcomes
We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of haemorrhoidal artery ligation for haemorrhoidal disease? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2014 (BMJ Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview).
Results
At this update, searching of electronic databases retrieved 150 studies. After deduplication and removal of conference abstracts, 70 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 46 studies and the further review of 24 full publications. Of the 24 full articles evaluated, one systematic review and seven RCTs were added at this update. We performed a GRADE evaluation for 11 PICO combinations.
Conclusions
In this systematic overview, we categorised the efficacy for seven comparisons, based on information about the effectiveness and safety of haemorrhoidal artery ligation versus closed haemorrhoidectomy, injection sclerotherapy, infrared coagulation, open excisional (Milligan-Morgan) haemorrhoidectomy, radiofrequency ablation, rubber band ligation, and stapled haemorrhoidectomy.
Key Points
Haemorrhoids are cushions of submucosal vascular tissue located in the anal canal starting just proximal to the dentate line. Haemorrhoidal disease occurs when there are symptoms such as bleeding, prolapse, pain, thrombosis, mucus discharge, and pruritus.
Incidence is difficult to ascertain as many people with the condition will never consult a medical practitioner. One study reported a prevalence of 39%, with nearly half of those identified reporting haemorrhoidal symptoms.
First- and second-degree haemorrhoids are classically treated with some form of non-surgical ablative/fixative intervention. Third-degree are treated with rubber band ligation or haemorrhoidectomy and fourth-degree with haemorrhoidectomy.
Eventual choice of treatment will be based on a number of individual and operative factors.
In previous versions of this overview we evaluated the evidence for a broad range of interventions for haemorrhoids, including closed haemorrhoidectomy, infrared coagulation/photocoagulation, injection sclerotherapy, open excisional (Milligan-Morgan) haemorrhoidectomy, radiofrequency ablation, rubber band ligation, and stapled haemorrhoidectomy. Haemorrhoidal artery ligation (HAL; also known as transanal haemorrhoidal de-arterialisation) has grown in popularity since the last overview. For this update we have, therefore, focused on the evidence for the effectiveness of HAL and how it compares to other selected surgical and non-surgical interventions for haemorrhoids. We evaluated evidence from RCTs and systematic reviews of RCTs.
We found insufficient evidence to judge the effectiveness of haemorrhoidal artery ligation compared with injection sclerotherapy, infrared coagulation, rubber band ligation, or radiofrequency ablation.
For haemorrhoidal artery ligation compared with stapled haemorrhoidectomy, closed haemorrhoidectomy, and open excisional (Milligan-Morgan) haemorrhoidectomy, the RCT evidence showed that there was a balance between the benefits (e.g., symptom and quality of life improvement, shortened length of hospital stay) and harms (e.g., postoperative pain, overall complications) associated with each procedure.
Clinical context
General background
Haemorrhoids are common in the general population. For people needing treatment there are a range of options available, although eventual choice of treatment will be based on a number of individual and operative factors.
Focus of the review
In previous versions of this overview we evaluated the evidence for a broad range of interventions for haemorrhoids, including closed haemorrhoidectomy, infrared coagulation/photocoagulation, injection sclerotherapy, open excisional (Milligan-Morgan) haemorrhoidectomy, radiofrequency ablation, rubber band ligation, and stapled haemorrhoidectomy. Haemorrhoidal artery ligation (HAL; also known as transanal haemorrhoidal de-arterialisation) has grown in popularity since the last overview. For this update, we have, therefore, focused on the evidence for the effectiveness of HAL and how it compares to other selected surgical and non-surgical interventions for haemorrhoids.
Comments on evidence
We found no RCTs comparing HAL with injection sclerotherapy, infrared coagulation, rubber band ligation, or radiofrequency ablation. We found one systematic review and three subsequent RCTs comparing HAL with stapled haemorrhoidectomy; two RCTs comparing HAL with closed haemorrhoidectomy; and two RCTs of HAL versus open excisional (Milligan-Morgan) haemorrhoidectomy. Overall, the quality of the evidence ranged from moderate to very low.
Search and appraisal summary
The update literature search for this overview was carried out from the date of the last search, May 2008, to October 2014. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the overview, please see the Methods section. Searching of electronic databases retrieved 150 studies. After deduplication and removal of conference abstracts, 70 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 46 studies and the further review of 24 full publications. Of the 24 full articles evaluated, one systematic review and seven RCTs were added at this update. In addition, one systematic review published after the search date of this overview was added to the Comment section.
About this condition
Definition
Haemorrhoids are cushions of submucosal vascular tissue located in the anal canal starting just proximal to the dentate line. These vascular cushions are a normal anatomical structure of the anal canal, and their existence does not necessarily indicate haemorrhoidal disease. Haemorrhoidal disease occurs when there are symptoms such as bleeding, prolapse, pain, thrombosis, mucus discharge, and pruritus. Rectal bleeding is the most common manifestation of haemorrhoidal disease. The bleeding tends to be bright red in nature and is visible on the toilet tissue or drips into the toilet bowl. Haemorrhoids can occur internally, externally, or can be mixed (internal and external components). If prolapse occurs, a perianal mass may be evident with defecation. Haemorrhoids may be classified into internal haemorrhoids, originating from the internal haemorrhoidal plexus above the dentate line, and external haemorrhoids, originating from the external haemorrhoidal plexus below the dentate line. Internal haemorrhoids are traditionally graded into four degrees.[1] First degree (or grade I) The haemorrhoids bleed with defecation but do not prolapse. First-degree haemorrhoids associated with mild symptoms are usually secondary to leakage of blood from mildly inflamed, thin-walled veins or arterioles. Conservative management with dietary manipulation (addition of fibre) and attention to anal hygiene is often adequate.[2] Recurrent rectal bleeding may require ablation of the vessels with non-surgical ablative techniques, such as injection sclerotherapy, infrared coagulation, or rubber band ligation. Infrared coagulation is used infrequently in clinical practice in the UK today, whereas rubber band ligation and injection sclerotherapy are commonly used. Second degree (grade II) The haemorrhoids prolapse with defecation and reduce spontaneously. Second-degree haemorrhoids can be treated with rubber band ligation or other non-surgical ablative techniques. Third degree (grade III) The haemorrhoids prolapse and require manual reduction. In third-degree haemorrhoids, where there is significant destruction of the suspensory ligaments, relocation and fixation of the mucosa to the underlying muscular wall is generally necessary. Prolapse can be treated with rubber band ligation initially, but haemorrhoidectomy may be required, especially if prolapse is seen in more than one position.[2] Fourth degree (grade IV) The haemorrhoids prolapse and cannot be reduced. If treatment is necessary, fourth-degree haemorrhoids require haemorrhoidectomy. Haemorrhoids are thought to be associated with chronic constipation, straining to defecate, pregnancy, and low dietary fibre. Frequency, duration, and severity of haemorrhoidal symptoms, such as bleeding, prolapse, or both, determine the type of treatment. Often, absent or episodic symptoms do not require treatment, and the presence of symptoms does not mandate invasive treatment. Some people decline treatment if they can be appropriately reassured that there is no other, more serious, reason for their symptoms.
Incidence/ Prevalence
Haemorrhoids are common in the general population. The incidence is difficult to ascertain, as many people with the condition will never consult a medical practitioner, but up to 10 million people in the US are reported to be affected.[2] One Austrian study of nearly 1000 patients undergoing bowel cancer screening colonoscopy reported haemorrhoids to be prevalent in 39% of patients. In 73% of these cases, the haemorrhoids were classified as grade I, 18% were classified as grade II, 8% as grade III, and 1% as grade IV. Of those diagnosed with haemorrhoids, only 45% reported haemorrhoidal symptoms.[3]
Aetiology/ Risk factors
The cause of haemorrhoids remains unknown, but a downward slide of the anal vascular cushions is considered the most likely explanation.[4] Other possible causes include straining to defecate, erect posture, and obstruction of venous return from raised intra-abdominal pressure (e.g., in pregnancy). It is thought that there may be a hereditary predisposition in some people, possibly due to a congenital weakness of the venous wall or suspensory haemorrhoidal ligaments. Diagnosis Accurate diagnosis requires a detailed history, thorough examination, and proctoscopic inspection of the anal canal and distal rectum. It is important to exclude other conditions such as colorectal cancer or inflammatory bowel disease in people who present with haemorrhoids.[2]
Prognosis
The prognosis is generally excellent, as many symptomatic episodes will often settle with conservative measures only. If further intervention is required, the prognosis remains good, although symptoms may recur. Early in the clinical course of haemorrhoids, prolapse reduces spontaneously. Later, the prolapse may require manual reduction and might result in mucus discharge, which can cause pruritus ani. Pain is usually not a symptom of internal haemorrhoids, unless the haemorrhoids are prolapsed. Pain may be associated with thrombosed external haemorrhoids. Death from bleeding haemorrhoids is extremely rare.
Aims of intervention
To relieve symptoms (rectal bleeding, prolapse, pruritus ani, mucus discharge, pain); to reassure the patient that no other pathology is causing the symptoms; to minimise the adverse effects of treatment.
Outcomes
Symptom improvement (bleeding, recurrent prolapse, need for additional treatment post-procedure); length of hospital stay; quality of life, including time to return to work and normal activities; adverse effects (overall complications, time to wound healing, bleeding, constipation, incontinence, infection, nausea and vomiting, pain, rectal tenesmus, stenosis, urinary retention, wound dehiscence).
Methods
Search strategy BMJ Clinical Evidence search and appraisal date October 2014. Databases used to identify studies for this systematic overview include: Medline 1966 to October 2014, Embase 1980 to October 2014, The Cochrane Database of Systematic Reviews 2014, issue 10 (1966 to date of issue), the Database of Abstracts of Reviews of Effects (DARE), and the Health Technology Assessment (HTA) database. Inclusion criteria Study design criteria for inclusion in this systematic overview were published systematic reviews and RCTs published in English, including 'unblinded' or 'open' studies, and containing at least 20 individuals per treatment arm, of whom more than 80% were followed up. There was no minimum length of follow-up. We have considered only adults in this overview and have excluded pregnant women. BMJ Clinical Evidence does not necessarily report every study found (e.g., every systematic review). Rather, we report the most recent, relevant, and comprehensive studies identified through an agreed process involving our evidence team, editorial team, and expert contributors. Evidence evaluation A systematic literature search was conducted by our evidence team, who then assessed titles and abstracts, and finally selected articles for full text appraisal against inclusion and exclusion criteria agreed a priori with our expert contributors. In consultation with the expert contributors, studies were selected for inclusion and all data relevant to this overview extracted into the benefits and harms section of the overview. In addition, information that did not meet our pre-defined criteria for inclusion in the benefits and harms section may have been reported in the 'Further information on studies' or 'Comment' section. Adverse effects All serious adverse effects, or those adverse effects reported as statistically significant, were included in the harms section of the overview. Pre-specified adverse effects identified as being clinically important were also reported, even if the results were not statistically significant. Although BMJ Clinical Evidence presents data on selected adverse effects reported in included studies, it is not meant to be, and cannot be, a comprehensive list of all adverse effects, contraindications, or interactions of included drugs or interventions. A reliable national or local drug database must be consulted for this information. Comment and Clinical guide sections In the Comment section of each intervention, our expert contributors may have provided additional comment and analysis of the evidence, which may include additional studies (over and above those identified via our systematic search) by way of background data or supporting information. As BMJ Clinical Evidence does not systematically search for studies reported in the Comment section, we cannot guarantee the completeness of the studies listed there or the robustness of methods. Our expert contributors add clinical context and interpretation to the Clinical guide sections where appropriate. Structural changes this update At this update, we have focused on haemorrhoidal artery ligation. Data and quality To aid readability of the numerical data in our overviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). BMJ Clinical Evidence does not report all methodological details of included studies. Rather, it reports by exception any methodological issue or more general issue that may affect the weight a reader may put on an individual study, or the generalisability of the result. These issues may be reflected in the overall GRADE analysis. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table.
GRADE Evaluation of interventions for Haemorrhoids: haemorrhoidal artery ligation.
| Important outcomes | Adverse effects, Length of hospital stay, Quality of life, Symptom improvement | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of haemorrhoidal artery ligation for haemorrhoidal disease? | |||||||||
| 1 (60) | Symptom improvement | Haemorrhoidal artery ligation versus closed haemorrhoidectomy | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (60) | Length of hospital stay | Haemorrhoidal artery ligation versus closed haemorrhoidectomy | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (40) | Quality of life | Haemorrhoidal artery ligation versus closed haemorrhoidectomy | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, methodological limitations (lack of statistical analysis of between-group difference), and incomplete reporting of results |
| 2 (100) | Adverse effects | Haemorrhoidal artery ligation versus closed haemorrhoidectomy | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 2 (90) | Symptom improvement | Haemorrhoidal artery ligation versus open excisional (Milligan-Morgan) haemorrhoidectomy | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data, and for methodological limitations (open-label nature of trials and lack of statistical analysis between groups) |
| 2 (90) | Quality of life | Haemorrhoidal artery ligation versus open excisional (Milligan-Morgan) haemorrhoidectomy | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, methodological limitations (open-label nature of trials), and incomplete reporting of results |
| 2 (90) | Adverse effects | Haemorrhoidal artery ligation versus open excisional (Milligan-Morgan) haemorrhoidectomy | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, methodological limitations (open-label nature of trials and lack of statistical analysis of between-group difference for some outcomes), and incomplete reporting of results |
| 6 (441) | Symptom improvement | Haemorrhoidal artery ligation versus stapled haemorrhoidectomy | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for methodological limitations (self-reporting of some outcomes, open-label nature of 2 RCTs); directness point deducted for uncertainty about baseline severity of haemorrhoids in meta-analysis |
| 1 (169) | Length of hospital stay | Haemorrhoidal artery ligation versus stapled haemorrhoidectomy | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and open-label nature of trial; directness point deducted for imbalance in use of local or pudendal anaesthesia after surgery |
| 2 (259) | Quality of life | Haemorrhoidal artery ligation versus stapled haemorrhoidectomy | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for weak methods (open-label nature of 1 RCT and lack of detail on method of randomisation) and incomplete reporting (lack of statistical assessment for between group comparison in one RCT) |
| 6 (441) | Adverse effects | Haemorrhoidal artery ligation versus stapled haemorrhoidectomy | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for methodological limitations (open-label nature of 2 RCTs); directness point deducted for uncertainty about baseline severity of haemorrhoids in meta-analysis |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
Glossary
- Anopexy
An augmentation of haemorrhoidal artery ligation, in which a series of running mucosal sutures gather up the redundant haemorrhoids to achieve reduction of the mucosal prolapse. Also termed a 'mucopexy'.
- Closed haemorrhoidectomy
An operative technique (an example of which is the Ferguson haemorrhoidectomy) whereby the haemorrhoid is excised (generally using scissors or diathermy) and the resulting defect is closed using sutures.
- Haemorrhoidal artery ligation (HAL)
Selective ligation of the arteries supplying blood to the haemorrhoids using a specially designed anoscope with a Doppler guided facility to identify the appropriate vessels.
- Infrared coagulation/photocoagulation
An outpatient procedure that uses infrared energy to produce an area of submucosal fibrosis, leading to mucosal fixation and a reduction in the tendency to prolapse.
- Injection sclerotherapy
An outpatient procedure that allows oily phenol to be injected into the submucosa of the rectum, around the pedicles of the haemorrhoids. The oily phenol acts as an irritant, which induces a fibrotic reaction and obliteration of the haemorrhoidal vessels and resultant atrophy of the haemorrhoids.
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Mucopexy
An augmentation of haemorrhoidal artery ligation, in which a series of running mucosal sutures gather up the redundant haemorrhoids to achieve reduction of the mucosal prolapse. Also termed an 'anopexy'.
- Open excisional (Milligan-Morgan) haemorrhoidectomy
An operative technique whereby the haemorrhoid is excised (generally using scissors or diathermy) and the resulting defect is left open to heal by secondary intention.
- Proctoscopy
In the UK, 'proctoscopy' refers to examination of the anal canal and distal rectum. In North America, the term 'anoscopy' is used.
- Radiofrequency ablation
A technique that ablates tissue by converting radiofrequency waves into heat.
- Rubber band ligation
An outpatient procedure that allows between one and three rubber bands to be applied to the rectal mucosa above the haemorrhoid(s), leading to mucosal fixity and a reduction in the tendency to prolapse.
- Short Form (SF-12)
A generic, multi-purpose short-form survey with 12 questions selected from the SF-36 Health Survey. The responses, when combined, scored, and weighted, result in two scales of mental and physical functioning and overall health-related quality of life.
- Stapled haemorrhoidectomy
An operative technique that uses a circular stapling device inserted into the rectum through the anal canal to facilitate pulling up of the prolapsed haemorrhoidal tissue, removal of redundant rectal mucosa, and stapling off the terminal branches of the superior haemorrhoidal artery. The technique may be more accurately termed 'stapled haemorrhoidopexy', as the haemorrhoids themselves are not actually excised but relocated within the anal canal.
- Transanal haemorrhoidal de-arterialisation (THD)
An operation where a specially designed proctoscope with a built-in doppler ultrasound probe is used to identify the haemorrhoidal arteries in at least six locations around the anal clock face and place figure-of-eight sutures around these arteries above the dentate line, thus reducing arterial inflow into the haemorrhoids plexus. The operation may be augmented by a series of running mucosal sutures below the figure-of-eight stitch, which gather up the redundant haemorrhoids to achieve reduction of the mucosal prolapse. This is termed a 'mucopexy' or 'anopexy'.
- Very low-quality evidence
Any estimate of effect is very uncertain.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Alexander C. von Roon, Department of Surgery and Cancer, Imperial College London, London, UK.
George E. Reese, Imperial College Healthcare NHS Trust, London, UK.
Paris P. Tekkis, The Royal Marsden and Chelsea and Westminster Hospitals, Imperial College London, London, UK.
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