Rubber band ligation versus excisional haemorrhoidectomy for haemorrhoids
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The primary aim of this review is to compare the therapeutic efficacy (both short and long‐term) of rubber band ligation and excision haemorrhoidectomy with respect to symptom control. In addition, post‐procedure pain, days to return to work, re‐treatment rate, continence, reported complication rate, and quality of life scores associated with each procedure will be evaluated.
Background
Haemorrhoidal disease is ranked first amongst diseases of the rectum and large intestine, and the estimated worldwide prevalence ranges from 2.9 to 27.9%, of which more than 4% are symptomatic (Johanson 1990; Rogozina 2002). Approximately, one third of these patients seek physicians for advice. Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years (Parks 1955; Johanson 1990). Men are more frequently affected than women (Keighley 1993).
The anorectal vascular cushions along with the internal anal sphincter are essential in the maintenance of continence by providing soft tissue support and keeping the anal canal closed tightly. Haemorrhoids are considered to be due to the downward displacement of these vascular cushions due to the disruption of the supporting suspensory (Trietz) muscle (Thomson 1975; Haas 1984). The haemorrhoidal symptoms may be precipitated by various factors including low fibre diet, prolonged straining, constipation, diarrhoea and hard stool (Haas 1984; Thaha 2002).
Haemorrhoidal symptoms may vary from bleeding per rectum, prolapse of the haemorrhoidal cushions, pain from thrombosis, discomfort from itching, mucous discharge and incontinence especially of fluids. Based on the degree of prolapse, haemorrhoids are classified into four categories: first degree being non‐prolapsing, second degree prolapsing on straining with spontaneous reduction, third degree prolapsing on straining and requiring manual reduction while, fourth degree haemorrhoids are permanently prolapsed. The severity of symptoms does not necessarily correlate with the degree of haemorrhoids.
The treatment options for symptomatic haemorrhoids have varied over time. Measures have included conservative medical management, non‐surgical treatments and various surgical techniques including stapled haemorrhoidopexy. Advice regarding high fibre diet & bulk forming agents are some of the medical interventions, which may be effective in the prevention of constipation and sequelae of haemorrhoids (Brisinda 2000; Nisar 2003). In addition, numerous commercial ointment preparations are available for symptomatic treatment but with little objective evidence of their efficacy (Nisar 2003).
The various non‐surgical treatments include rubber band ligation, injection sclerotherapy, cryotherapy, infrared coagulation, laser therapy and diathermy coagulation; all of which may be performed as out patient procedures without anaesthesia. These non‐surgical methods are considered to be the primary option for grades one, two and three haemorrhoids (MacRae 1995). Of all the non‐surgical procedures, rubber band ligation seems to be the best option in terms of compliance, long‐term efficacy and side effects (MacRae 1995).
Rubber Band Ligation (RBL) is a quick, simple, inexpensive outpatient procedure, which was originally introduced by Blaisdell (Blaisdell 1958) and later modified by Barron (Barron 1963). The rubber bands are applied on an insensitive area just above the dentate line, preferably, up to three bands in one sitting, which can be safely repeated after 4‐6 weeks time. Different techniques are practiced for application of bands including the endoscopic ligation but the commonest being the suction method. The patient should be cautioned about bleeding after 10‐14 days when the banded haemorrhoid sloughs off. The success rate of ligation treatment varies between 69 and 94% among different studies (Bat 1993). RBL is associated with a low complication rate (less than 2%) (Sardinha 2002). It may range from vaso‐vagal syncope, anal pain, minor bleeding, chronic ulcer, priapism, difficulty in urination, thrombosis of external haemorrhoids, to life threatening complications such as massive bleeding, pelvis sepsis (Barwell 1999; Bat 1993).
If conservative measures fail to control symptoms, patients may be referred to a surgeon for operative management. The indications for the surgical treatment include the presence of a significant external component, hypertrophied papillae, associated fissure, extensive thrombosis or recurrence of symptoms after repeated RBL. The technique employed may be open (Milligan ‐Morgan) or closed (Ferguson) and the instruments used are scalpel, scissor, electrocautery or laser. Milligan‐Morgan haemorrhoidectomy is the gold standard and frequently performed procedure in the United Kingdom (Manson 2002). Post haemorrhoidectomy pain is the commonest problem associated with the surgical techniques. The other early complications are urinary retention (20.1%), bleeding (secondary or reactionary) (2.4 ‐ 6%) and subcutaneous abscess (0.5%). The long‐term complications include anal fissure (1‐2.6%), anal stenosis (1%), incontinence (0.4%), fistula (0.5%) and recurrence of haemorrhoids (Sardinha 2002; Bleday 1992).
A new alternative to heamorrhoidectomy is the stapled haemorrhoidopexy, introduced by Longo in 1998 (Longo 1998). In this operative technique, the vascular cushions are repositioned to their original site using a circular stapling device, by excising a circular strip of lower rectal mucosa. The long‐term results of this procedure are still awaited.
In spite of the availability of different treatment options, rubber band ligation and surgical haemorrhoidectomy are currently practised non‐surgical and surgical methods, respectively.
Objectives
The primary aim of this review is to compare the therapeutic efficacy (both short and long‐term) of rubber band ligation and excision haemorrhoidectomy with respect to symptom control. In addition, post‐procedure pain, days to return to work, re‐treatment rate, continence, reported complication rate, and quality of life scores associated with each procedure will be evaluated.
Methods
Criteria for considering studies for this review
Types of studies
All published randomised controlled trials comparing rubber band ligation with any form of excisional haemorrhoidectomy will be included for the study. Different methods of excisional haemorrhoidectomies, irrespective of the instrument used for excision, and the status of the wound at the end of the procedure (closed or open) will be eligible for inclusion if they are compared with rubber band ligation. Length of follow‐up will not be a criteria to exclude any study. Randomised studies published as abstracts will be included if the full version of the same is available from the authors. Quasi‐randomised, non‐randomised studies, letters and also studies comparing rubber band ligation with any non‐surgical treatment will be excluded. Arrangements will be made for translation of eligible papers from other languages using available resources.
Types of participants
All patients with symptomatic haemorrhoids of any grade, without distinction for age, gender or gestation, undergoing rubber band ligation or excisional haemorrhoidectomy within a randomised controlled setting will be the target patients to be included so that comparison could be made for the outcome measures.
Types of interventions
Rubber band ligation and excisional haemorrhoidectomy are included. Any types of excisional haemorrhoidectomy such as open, semi‐closed or closed procedures are the target interventions. The type of instrument used for excision will not be a criteria for exclusion.
Types of outcome measures
Haemorrhoidal symptom control is the primary outcome measure to be addressed in this review. In addition, duration of post procedural pain, time to return to normal activities, re‐treatment rate, patient satisfaction, and complications (incontinence, anal stenosis, sepsis, significant bleeding requiring readmission for further treatment) for each procedures will be considered for the secondary outcome measures. Quality of life will also be included if it is recorded. The primary author(s) will be contacted for any missing details.
Reports of symptom control may differ between studies based on the different symptoms, and can be expected to range from individual symptom analysis to overall scoring systems. To obtain a uniform report, these will be categorised into a four‐scale system as described below:
Cured ‐ Symptom free and requiring no further treatment
Improved ‐ Mild residual symptoms but not requiring further treatment at the study end period
Unchanged ‐ No symptom improvement and requiring further intervention
Worse ‐ Suffered complications of the procedure or deterioration of symptoms
Where difficulty in interpretation of results from a published paper occurs the first author will be contacted to obtain clarification of the data. Complications will be categorised individually and total percentage summarised for individual procedure.
Duration of post procedural pain for each procedure will be calculated based on the type of pain score adopted and compared individually. Similarly, re‐treatment rates for each procedure will be counted separately and will be compared between studies.
Quality of life score will be considered if they are reported in the study.
Search methods for identification of studies
ELECTRONIC SEARCHES:
The search strategy advocated by Cochrane colorectal cancer group (CCCG) will be adopted.
A comprehensive search of different electronic databases using a combination of free text and MESH (Medical Subject Heading) terms will be undertaken to identify potential studies for inclusion in the review. The following electronic databases will be searched for any trials comparing the two interventions:
The Cochrane Central Register of Controlled Trials (CENTRAL)
MEDLINE / PubMed (for latest publications)
1 controlled clinical trial.pt.
2 randomised controlled trial.pt.
3 randomised controlled trials/
4 random allocation/
5 double blind method/
6 single blind method/
7 or/1‐6
8 animals/not (animals/ and human/)
9 #7 not 8
10 clinical trial.pt.
11 exp clinical trials/
12 random$.tw.
13 research design/
14 (clin$ adj25 trial$).tw.
15 ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).tw.
16 factorial.tw.
17 (balance$ adj2 block$).tw.
18 animals/ not (animals/ and human/)
19 or/10‐17
20 #19 not 18
21 exp HEMORRHOIDS/
22 (hemorrhoid$ or haemorrhoid$).mp.
23 piles.mp.
24 or/21‐23
25 exp surgical procedures, operative/ or exp ligation
26 rubber band.mp.
27 ligature.mp.
28 diathermy.mp. or DIATHERMY/
29 Milligan Morgan.mp. or Surgical/
30 Ferguson.mp. or surgical/
31 Digestive System Surgical Procedures/ or Milligan Morgan.mp. or Surgical/
32 (haemorrhoidectom$ or hemorrhoidectom$).mp.
33 ligasure.mp.
34 laser.mp. or LASERS/
35 electrocautery.mp. or Electrocoagulation/
36 thermocoagulation.mp.
37 or/25‐36
38 #9 and 20 and 37
EMBASE
1.exp clinical trial/
2.comparative study/
3.major clinical study/
4.randomization/
5.double blind procedure/
6.single blind procedure/
7.prospective study/
8.((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).ti,ab.
9.(random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).ti,ab.
10.((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).ti,ab.
11.or/1‐10
12. animals/not (animals/ and human/)
13 #11 not 12
14 exp HEMORRHOIDS/
15 (hemorrhoid$ or haemorrhoid$).mp.
16 piles.mp.
17 or/14‐16
18 exp surgical procedures, operative/ or exp ligation
19 rubber band.mp.
20 ligature.mp.
21diathermy.mp. or DIATHERMY/
22 Milligan Morgan.mp. or Surgical/
23 Ferguson.mp. or surgical/
24 Digestive System Surgical Procedures/ or Milligan Morgan.mp. or Surgical/
25 (haemorrhoidectom$ or hemorrhoidectom$).mp.
26 ligasure.mp.
27 laser.mp. or LASERS/
28 electrocautery.mp. or Electrocoagulation/
29 thermocoagulation.mp.
30 or/18‐29
31#13 and 17 and 30
CINAHL
ADDITIONAL SEARCHES:
Current Controlled Trials (http://controlled‐trials.com/).
Ongoing Trials: National Research Register, Current Controlled Trials
These will be searched for the whole available period up to the most recent update of the databases at the time of the search.
Bibliographies of identified papers will be scrutinised for relevant studies.
Experts will be contacted for advice and peer review, and to identify additional published and unpublished references.
Web of Science Proceedings (the Institute for Science Information Proceedings allow access to abstracts from papers delivered at international conferences, symposia, seminars, colloquia, workshops, and conventions), Health Management Information Consortium (HMIC; this database focuses on community care and health systems management in the UK, Europe and developing countries including journals, books, reports, official publications)
Data collection and analysis
Two reviewers (VS and MAT) will undertake the literature search to individually identify the eligible studies. These reviewers to determine its eligibility according to the inclusion criteria will then assess the full text of the provisionally selected studies separately. In case of significant disagreement between the two reviewers, the next two reviewers (AJMW and KLC) will be involved to resolve the conflict. Two reviewers (VS and MAT) will independently extract the data from all the included studies on to a standardised data extraction form and third reviewer (KLC) will be involved in case of significant disagreement between the two.
Quality assessment
Two reviewers will independently assess the eligible trials for methodological quality. Information regarding the sample size, internal validity (to avoid selection, performance, detection and attrition bias), method of randomisation, blinding and effective concealment of allocation, intention to treat (accounting for all the included patients with out any drop outs), details of data analysis and length of follow‐up will be the focus of attention for including a trial for the review. Primary author will be contacted to get final opinion in case of unclear informartion with regards to any of the above.
Each outcome will be analysed individually. When the outcome measure cannot be combined into single data, descriptive summary of the results will be considered. Heterogenicity in the trial will be reported appropriately.
Sub‐group analysis with regards to the follow‐up duration (less and more than one year), pregnancy status and haemorrhoidal grade will be considered. Sensitivity analysis based on the adequacy of randomisation concealment will also be undertaken.
RJCS and MAL will review the final manuscript before submission.
