a variety of treatment options are available for haemorrhoidal disease . whereas early stages of the disease
can usually be treated conservatively with success , advanced stages require a surgical approach . at present ,
surgical treatment generally involves resection of the haemorrhoidal cushions , as in conventional haemorrhoidectomy ( ch ) or prolapse reduction as in stapled haemorrhoidopexy ( sh ) . despite excellent long - term results , ch is associated with significant side effects and complications .
in addition to excessive post - operative pain , symptoms of incontinence and anal stenosis have been described in considerable numbers [ 25 ] . for sh , results are more convenient concerning post - operative pain .
however , reoperations have been reported in up to 10  % of patients [ 5 , 6 ] and , albeit very rare , this technique can be associated with severe septic complications [ 5 , 7 ] .
minimally invasive treatment options have become popular over the last few decades , even in coloproctology .
doppler - guided haemorrhoidal artery ligation ( dg - hal ) was first described in 1995 by morinaga et al . .
the principle of the technique was to ligate the proximal submucosal haemorrhoidal arteries , thereby reducing the blood flow to the haemorrhoidal cushions and eventually leading to fibrosis and shrinking of the haemorrhoids .
haemorrhoidal artery ligation ( hal ) has since been analysed in several studies , which show excellent results for grade ii and iii haemorrhoidal disease .
however , while hal appears to control pain , bleeding , pruritus and mucous discharge with success , control of the prolapse seems to be more difficult in patients suffering from grade iii or grade iv haemorrhoids .
persistent or recurrent prolapse in grade iii disease has been described with rates of 6 , 9   and 14  % . in studies involving patients with grade iv disease , even higher recurrence rates ( rrs ) such as 24 , 59   and 67  %   have been observed . for these patients ,
in particular those suffering from grade iv haemorrhoids , reduction of inflow alone seems insufficient to reduce the haemorrhoidal cushions . recto - anal repair ( rar ) ,
a technique developed and described by scheyer , addresses this problem by supplementing hal with a further step , whereby the haemorrhoidal tissue is gathered up and lifted back into position .
based on this principle of tissue reduction , rar is an alternative to surgical removal that is made possible by placing a longitudinal running suture while using a specially designed proctoscope .
the aim of this prospective observational study for grade iii and iv haemorrhoidal disease was to review several technical aspects and analyze 1-year results of this new method ( dg - hal / rar ) in terms of recurrence of prolapse and symptoms other than prolapse .
this study was designed as a prospective observational study and was approved by the institutional review board .
included in the study were patients between the age of 18 and 80 years with symptomatic grade iii and iv haemorrhoidal disease ( according to goligher classification ) , who had given their informed consent .
patients with a history of prior anal surgery and those considered unfit for surgery were excluded .
prior to surgery , all patients underwent a detailed examination for symptoms of haemorrhoidal disease .
a standardised form was used to collect data from each patient during the study period . between march 2007 and december 2007 ,
patients were not required to enter the study in a consecutive order and the total number of patients screened was not documented .
of those 184 patients , 124 were male ( 65  % ) and 64 female ( 35  % ) .
the number of patients suffering from grade iii haemorrhoids was 107 ( 58  % ) , while 77 patients ( 42  % ) were classified to suffer from grade iv haemorrhoids .
pain was reported by 136 patients ( 74  % ) , itching by 139 ( 76  % ) and bleeding by 174 ( 95  % ) .
, there is a lateral opening proximal to the ultrasound probe that allows detection and ligation of the feeding vessels ( haemorrhoidal artery ligation ) .
rotating the outer tube of the proctoscope gradually opens a lateral slit to enable placement of a running suture , which serves to reduce the anal cushions and secure them back in their anatomical position ( prolapse reduction ) .
follow - up with a physical examination and questioning for recurrence of symptoms and satisfaction was performed 3 and 12 months after surgery by the treating physician .
a linear regression analysis was performed to test influence of certain variables on recurrence of prolapse , recurrence of symptoms and patient satisfaction .
a median of six ( 211 ) ligations and three ( range 19 ) prolapse - reduction sutures ( prss ) were performed , whereby 80  % of patients had six or more ligations , and 80  % of patients had three or more prss .
surgery was performed under general anaesthesia in 132 patients ( 72  % ) , spinal anaesthesia in 45 ( 25  % ) and local anaesthesia in 7 ( 4  % ) .
instances of significant bleeding during the procedure were observed in three patients ( 2  % ) .
post - operative complications were seen in 14 patients ( 8  % ) . among them , 2 patients ( 1  % ) suffered from bleeding which required operative revision , 11 patients ( 7  % ) had perianal thromboses and 1 patient ( 1  % ) was diagnosed with unspecified proctitis .
the mean duration of the hospital stay was 2.3 days ( range 19 ) . in the immediate post - operative period ,
i.e. prior to discharge from hospital , 20  % of the patients reported pain higher than vas 4 .
this gradually diminished by day 4 , where only 3  % of patients reported pain higher than vas 4 .
thirteen patients ( 7  % ) reported pain higher than vas 7 immediately after surgery .
there was only one patient with persistent pain for more than 4 days , post - operatively ( table  1 ) .
table 1burden of post - operative pain as measured by visual analogue scale ( vas  ~  110)time ( day)vas   3 n ( % ) vas 46 n ( % ) vas   7 n ( % ) total n1115 ( 74.2)34 ( 21.9)6 ( 3.9)1552102 ( 79.8)22 ( 17.2)4 ( 3.1)128395 ( 84.8)12 ( 10.7)5 ( 4.5)112493 ( 85.3)15 ( 13.7)1 ( 0.9)109 burden of post - operative pain as measured by visual analogue scale ( vas  ~  110 ) three months follow - up was completed for all 184 patients ( table  2 ) . pain was still present in 14 patients ( 8  % ) , itching in 19 ( 10  % ) and bleeding in 11 ( 6  % ) .
one hundred and sixty - seven patients ( 91  % ) were free of symptoms and 168 patients ( 91  % ) were overall satisfied with the result of the procedure .
of these patients , 28 ( 15  % ) received further treatment including ch ( 1 patient , 1  % ) , excision of skin tags ( 12 patients , 7  % ) , sclerotherapy ( 5 patients , 3  % ) and treatment with an ointment , undefined and by surgeon preference ( 10 patients , 5  % ) .
table 2preoperative status compared with 3 and 12 months post - operative statusbefore surgery ( n  =  184 ; % ) 3 months ( n  =  184 ; % ) 12 months ( n  =  167 ; % ) pain136 ( 73.9)14 ( 7.6)10 ( 4.8)itching139 ( 75.5)19 ( 10.3)9 ( 4.2)bleeding174 ( 94.6)11 ( 5.9)13 ( 6.6)patient satisfaction168 ( 91.3)148 ( 87.6)prolapse184 ( 100)12 ( 6.5)21 ( 11.4)symptom and prolapse free162 ( 88)141 ( 84.4)symptom free167 ( 90.8)152 ( 89.4)further treatment28 ( 15.2)32 ( 18.9 ) preoperative status compared with 3 and 12 months post - operative status at 12 month , follow - up was completed for 167 patients ( 92  % ) .
pain was still present in 10 of these patients ( 5  % ) , itching in 9 ( 4  % ) and bleeding in 13 ( 7  % ) .
one hundred and fifty - two patients ( 89  % ) were free of symptoms and 148 patients ( 88  % ) were satisfied with the result of the procedure .
thirty - two patients received one or more further treatments ( 19  % ) .
these included ch ( n  =  2 ) , excision of skin tags ( n  =  12 ) , sclerotherapy ( n  =  5 ) , rubber band ligation ( n  =  4 ) and treatment with an ointment , undefined and by surgeon preference ( n  =  13 ) . grade of disease , sex , age and the number of ligations and prss were tested for their respective influence on the recurrence of prolapse or symptoms , and patient satisfaction .
with respect to recurrence of prolapse , there was a significant difference between patients with grade iii and iv disease ( tables  3 and 4 ) .
the number of prss , and in particular the number of ligations , were shown to have significant influence on the recurrence of symptoms . with respect to symptom recurrence ,
optimal results were obtained with five to seven ligations ( median 6 ) and three to four prss ( median 4 ) .
table 3effectiveness of dg - rar at 3 and 12 months , stratified for grade of haemorrhoidal disease3 months12 monthsgrade iii ( n  =  107 ; % ) grade iv ( n  =  77 ; % ) grade iii ( n  =  99 ; % ) grade iv ( n  =  70 ; % ) recurrence of prolapse6 ( 6)6 ( 8)8 ( 8)13 ( 18)pain5 ( 5)9 ( 12)3 ( 3)7 ( 10)itching9 ( 8)10 ( 13)2 ( 2)7 ( 10)bleeding3 ( 3)8 ( 10)2 ( 2)8 ( 11)patient satisfaction88.894.787.088.4 effectiveness of dg - rar at 3 and 12 months , stratified for grade of haemorrhoidal disease table 4multi - variate analysis of factors influencing the parameters of efficacyrecurrence of prolapserecurrence of symptomspatient satisfactionrr ( range)prr ( range)prr ( range)pligations  0.04 (   0.83 to 0.16)0.18  0.12 (   0.17 to   0.07)0.00010.115 ( 0.06 to 0.17)0.0001grade0.14 ( 0.03 to 0.2)0.010.63 (   0.38 to 0.16)0.221  0.22 (   0.13 to 0.09)0.69sex  0.07 (   0.17 to 0.03)0.17  0.93 (   0.19 to 0.01)0.053  0.19 (   0.7 to 0.32)0.46age0.004 ( 0.0 to 0.01)0.0570.002 (   0.003 to 0.00)0.4740.02 (   0.87 to 0.12)0.77prs0.3 (   0.17 to 0.08)0.20.052 ( 0.006 to 0.09)0.0280.0 (   0.01 to 0.04)0.91rr recurrence rate , prs prolapse - reduction suture multi - variate analysis of factors influencing the parameters of efficacy rr recurrence rate , prs prolapse - reduction suture one patient ( 1  % ) had anal stenosis - requiring dilation .
one patient ( 1  % ) suffered from urinary retention . although considerable time had elapsed between the procedure and the onset of urinary retention , no other cause could be found .
one patient ( 1  % ) reported mild faecal incontinence 7 months after the procedure .
a median of six ( 211 ) ligations and three ( range 19 ) prolapse - reduction sutures ( prss ) were performed , whereby 80  % of patients had six or more ligations , and 80  % of patients had three or more prss .
surgery was performed under general anaesthesia in 132 patients ( 72  % ) , spinal anaesthesia in 45 ( 25  % ) and local anaesthesia in 7 ( 4  % ) .
instances of significant bleeding during the procedure were observed in three patients ( 2  % ) .
post - operative complications were seen in 14 patients ( 8  % ) . among them , 2 patients ( 1  % ) suffered from bleeding which required operative revision , 11 patients ( 7  % ) had perianal thromboses and 1 patient ( 1  % ) was diagnosed with unspecified proctitis .
in the immediate post - operative period , i.e. prior to discharge from hospital , 20  % of the patients reported pain higher than vas 4 .
this gradually diminished by day 4 , where only 3  % of patients reported pain higher than vas 4 .
thirteen patients ( 7  % ) reported pain higher than vas 7 immediately after surgery .
there was only one patient with persistent pain for more than 4 days , post - operatively ( table  1 ) .
table 1burden of post - operative pain as measured by visual analogue scale ( vas  ~  110)time ( day)vas   3 n ( % ) vas 46 n ( % ) vas   7 n ( % ) total n1115 ( 74.2)34 ( 21.9)6 ( 3.9)1552102 ( 79.8)22 ( 17.2)4 ( 3.1)128395 ( 84.8)12 ( 10.7)5 ( 4.5)112493 ( 85.3)15 ( 13.7)1 ( 0.9)109 burden of post - operative pain as measured by visual analogue scale ( vas  ~  110 )
three months follow - up was completed for all 184 patients ( table  2 ) .
pain was still present in 14 patients ( 8  % ) , itching in 19 ( 10  % ) and bleeding in 11 ( 6  % ) .
one hundred and sixty - seven patients ( 91  % ) were free of symptoms and 168 patients ( 91  % ) were overall satisfied with the result of the procedure .
of these patients , 28 ( 15  % ) received further treatment including ch ( 1 patient , 1  % ) , excision of skin tags ( 12 patients , 7  % ) , sclerotherapy ( 5 patients , 3  % ) and treatment with an ointment , undefined and by surgeon preference ( 10 patients , 5  % ) .
table 2preoperative status compared with 3 and 12 months post - operative statusbefore surgery ( n  =  184 ; % ) 3 months ( n  =  184 ; % ) 12 months ( n  =  167 ; % ) pain136 ( 73.9)14 ( 7.6)10 ( 4.8)itching139 ( 75.5)19 ( 10.3)9 ( 4.2)bleeding174 ( 94.6)11 ( 5.9)13 ( 6.6)patient satisfaction168 ( 91.3)148 ( 87.6)prolapse184 ( 100)12 ( 6.5)21 ( 11.4)symptom and prolapse free162 ( 88)141 ( 84.4)symptom free167 ( 90.8)152 ( 89.4)further treatment28 ( 15.2)32 ( 18.9 ) preoperative status compared with 3 and 12 months post - operative status at 12 month , follow - up was completed for 167 patients ( 92  % ) .
pain was still present in 10 of these patients ( 5  % ) , itching in 9 ( 4  % ) and bleeding in 13 ( 7  % ) .
one hundred and fifty - two patients ( 89  % ) were free of symptoms and 148 patients ( 88  % ) were satisfied with the result of the procedure .
thirty - two patients received one or more further treatments ( 19  % ) .
these included ch ( n  =  2 ) , excision of skin tags ( n  =  12 ) , sclerotherapy ( n  =  5 ) , rubber band ligation ( n  =  4 ) and treatment with an ointment , undefined and by surgeon preference ( n  =  13 ) .
grade of disease , sex , age and the number of ligations and prss were tested for their respective influence on the recurrence of prolapse or symptoms , and patient satisfaction . with respect to recurrence of prolapse
, there was a significant difference between patients with grade iii and iv disease ( tables  3 and 4 ) .
the number of prss , and in particular the number of ligations , were shown to have significant influence on the recurrence of symptoms . with respect to symptom recurrence ,
optimal results were obtained with five to seven ligations ( median 6 ) and three to four prss ( median 4 )
table 3effectiveness of dg - rar at 3 and 12 months , stratified for grade of haemorrhoidal disease3 months12 monthsgrade iii ( n  =  107 ; % ) grade iv ( n  =  77 ; % ) grade iii ( n  =  99 ; % ) grade iv ( n  =  70 ; % ) recurrence of prolapse6 ( 6)6 ( 8)8 ( 8)13 ( 18)pain5 ( 5)9 ( 12)3 ( 3)7 ( 10)itching9 ( 8)10 ( 13)2 ( 2)7 ( 10)bleeding3 ( 3)8 ( 10)2 ( 2)8 ( 11)patient satisfaction88.894.787.088.4 effectiveness of dg - rar at 3 and 12 months , stratified for grade of haemorrhoidal disease table 4multi - variate analysis of factors influencing the parameters of efficacyrecurrence of prolapserecurrence of symptomspatient satisfactionrr ( range)prr ( range)prr ( range)pligations  0.04 (   0.83 to 0.16)0.18  0.12 (   0.17 to   0.07)0.00010.115 ( 0.06 to 0.17)0.0001grade0.14 ( 0.03 to 0.2)0.010.63 (   0.38 to 0.16)0.221  0.22 (   0.13 to 0.09)0.69sex  0.07 (   0.17 to 0.03)0.17  0.93 (   0.19 to 0.01)0.053  0.19 (   0.7 to 0.32)0.46age0.004 ( 0.0 to 0.01)0.0570.002 (   0.003 to 0.00)0.4740.02 (   0.87 to 0.12)0.77prs0.3 (   0.17 to 0.08)0.20.052 ( 0.006 to 0.09)0.0280.0 (   0.01 to 0.04)0.91rr recurrence rate , prs prolapse - reduction suture multi - variate analysis of factors influencing the parameters of efficacy rr recurrence rate , prs prolapse - reduction suture
one patient ( 1  % ) suffered from urinary retention . although considerable time had elapsed between the procedure and the onset of urinary retention , no other cause could be found .
one patient ( 1  % ) reported mild faecal incontinence 7 months after the procedure .
while a variety of treatment options is available for grade i and ii haemorrhoids , only sh and ch are considered to be a standard treatment for grade iii disease , and just ch in the case of grade iv . in a meta - analysis ,
however , both treatment options can be associated with extensive post - operative pain , faecal incontinence and anal stenosis .
nonetheless , for most authors ch remains the standard treatment for advanced piles , because novel techniques including sh do not show the same effectiveness .
although initial results from single centres have been promising [ 10 , 12 , 1417 ] , dg - hal / rar has not yet been adequately evaluated for grade iii and iv haemorrhoids .
the present study is the first international , multi - centre observational trial on the safety and effectiveness of dg - hal / rar .
results achieved by ch at 12 months are slightly better than those recorded during our trial . in terms of control of other symptom , results from our series of high - grade hal / rar patients were superior to those published for ch und sh .
most studies for grade iii and iv haemorrhoids focus on the recurrence of prolapse , although prolapse may not be the leading symptom in a significant number of patients .
we believe that control of symptoms other than prolapse and patient satisfaction is more relevant in evaluating efficacy . in terms of pain , pruritus or bleeding , almost nine out of ten patients were treated successfully and satisfied after a follow - up of 12 months . in most cases ,
the variation was due to the persistence or development ( as a result of shrinkage of haemorrhoidal tissue ) of skin tags , which subsequently required further treatment .
this problem is also prevalent among patients having undergone ch and sh . in our series ,
7  % of patients required rubber band ligation , sclerotherapy or haemorrhoidectomy within 12 months of undergoing dg - hal / rar and 8  % of patients received unspecified topical ointments , which we consider to be a low number . taking all the above factors into account , we consider that our study demonstrates dg - hal / rar to be a safe and effective technique for grade iii and iv haemorrhoids .
however , it should be noted that this study was not designed to assess post - operative pain for dg - hal / rar and , as such , pain assessment was only performed during the patient s hospital stay .
the greatest extent of pain was experienced immediately post - operatively , and the most frequent cause of pain was perianal thrombosis . as the median hospital stay was only 2 days and patients without post - operative pain would have been discharged early , the number of patients with higher pain levels may be over - represented . despite this technicality , post - operative pain would appear to be quite low .
it should be mentioned that some centres performed the dg - hal / rar as a day - case procedure , but others require an overnight stay due to reimbursement considerations .
for the first time in a study concerning dg - hal / rar , a multi - variate analysis was carried out to demonstrate the statistically significant influence of various factors on parameters of efficacy .
the number of prss and in particular the number of ligations were shown to influence the recurrence of symptoms , whereas the only factor affecting the recurrence of prolapse was the grade of disease .
it is interesting to note that the only factor significantly influencing patient satisfaction was the number of ligations .
our data show a trend towards five to seven ligations and three to four prss ; however , as the number of prss and ligations depended on each patient s vascularity as well as the surgeon s opinion intra - operatively , and therefore varied considerably , it is difficult to establish the optimum number of ligations .
hal - rar proved to be safe and effective in the present study , showing an acceptable prolapse rr of 11  % after 12 months for this series of high - grade haemorrhoid patients ( 59  % grade iii , 41  % grade iv ) .
symptom control and patient satisfaction are high , resulting in approximately nine out of ten patients staying symptom - free and satisfied 1 year after surgery .
the perioperative complications , which were low in number , were primarily cases of perianal thrombosis and post - operative bleeding . however ,
to answer the question of the optimum treatment modality ( ch , sh and dg - hal / rar ) for advanced haemorrhoidal disease , a controlled randomized trial would be needed .
a multi - centre approach seems mandatory , because no single institution will be able to enrol enough patients or perform all three techniques with adequate experience . however , fully informed consent for such a trial may be problematic . in the absence of such a trial
, the nine centres contributing to this study have chosen hal - rar as their first - line treatment for high - grade haemorrhoids owing to the perioperative benefits , very low number of complications , good symptom control and acceptably low rr .
the authors confirm that they have no form of commercial association , including but not limited to consultancy agreements , stock ownership , equity interests or patent or licensing arrangements , which may represent a conflict of interest in connection with the manuscript .
this article is distributed under the terms of the creative commons attribution license which permits any use , distribution , and reproduction in any medium , provided the original author(s ) and the source are credited .
 summarybackgroundultrasound - guided techniques represent a new treatment option in the treatment of haemorrhoids . 
 doppler - guided haemorrhoidal artery ligation ( dg - hal ) proved efficacious in early haemorrhoidal disease , but lacks efficacy for stages iii / iv . 
 for these patients , haemorrhoidal artery ligation ( hal ) has been combined with a running suture to reduce prolapsing haemorrhoidal tissue ( recto - anal repair ( rar)).methodsa prospective observational study was conducted in 184 patients with grade iii ( 58  % ) or grade iv ( 42  % ) haemorrhoids in seven coloproctological centres . 
 primary endpoints were the recurrence of symptoms and need of further treatment ( medical or surgical).resultspost - operative complications were seen in 8  % of patients . 
 after a follow - up of 3 months , 91  % of patients were free of symptoms and 91  % of patients were satisfied with the result . 
 after a follow - up of 12 months , 89  % of patients were free of symptoms and 88  % were satisfied with the result . 
 nineteen per cent of patients received further medical or surgical treatment.conclusionsdoppler-guided recto - anal repair ( dg - rar ) proves to be an effective treatment option for the treatment of advanced haemorrhoidal disease that shows equal results to other established treatment options . 
Introduction
Patients and methods
Results
Surgical procedure
Post-operative pain
Recurrence of symptoms
Factors influencing outcome
Complications
Discussion
Conclusion
Conflict of interest
Open Access