Ligation-anopexy versus pile suture for treatment of advanced hemorrhoidal disease: Randomized controlled study

Ligation-anopexy versus pile suture for treatment of advanced hemorrhoidal disease: Randomized controlled study

Khaled S Abbas, MD, PhD; Khaled M. Madbouly, MD, Ph.D, MRCS(Glasg)

Ahmed M. Hussein, MCh, Dr.

Department of Surgery, University of Alexandria, Alexandria, Egypt.

The aim of this study is to compare ligation-anopexy and pile suture for treatment of 3rd and

4th degree hemorrhoidal disease.

Patients and methods: 60 patients (28 females) complaining of symptoms of advanced hemorrhoidal disease were included in the study. Patients were divided into two groups, group A underwent ligation-anopexy and group B underwent pile suture. Operating time, post operative pain, time offwork, complications and recurrence of symptoms were analyzed.

Results: Mean age in group I was 42.6 ±14.04 while in group II was 40.8±11.17 years.  The

operative time for group I was 18.3 ±4.12 minutes versus 22.83 ±7.05 group II and mean follow up for group I was 13.73 ±2.12 while for group!! it was 14.21 ±2.26 months. Follow up showed that mean VAS pain in pile suture group was significantly higher at 1st post-operative day (2.43

±0.94 vs 4.97 ±1.65) and atthe end of first week (0.43 ±0.63 vs1.07 ±1.17). Mean time needed for the patients to return to normal activity was slightly lower  in group I (5.3±  1.54 days) than in group II (6.90 ±2.14 days). Post-operative  complications  included thrombosis which occured in 4 patients of group II, temporary  anal spasm occured in three patients of group I and two patients of group II. Skin tags were the most common complication in both groups. The recurrence of symptoms was significantly higher after pile suture (16.7%) than after ligation­ anopexy (3.3%).

Conclusion:  Anopexy  may  improve  complications  and  recurrence  rate  when  added  to ligation for treatment of advanced hemorrhoidal disease.

Introduction:

Advanced   hemorrhoidal    disease   (third and fourth degree) is presented clinically by prolapsed lump which may require manual reduction or constantly prolapsed. Other clinical manifestations include painless bleeding,    discomfort,    hygiene    problems and pruritus.l,2 About one third of patients suffering from hemorrhoidal disease seek medical attention.3,4 About 5-10% of patients do not respond to conservative treatments, so surgical procedures become the treatment of choice for such cases.5

Although  some  studies  reported  that rubber band ligation is safe and effective method compared to open technique in 3rd degree  symptomatic  hemorrhoidal  disease,6

it is stated in the revised practice parameters

for     the    management     of    hemorrhoidal disease that hemorrhoidectomy should be offered  to  patients  with  grades  III  or  IV.3

Hemorrhoidectomy is the most effective treatment for hemorrhoidal disease with the lowest rate of recurrence compared to other modalities but it is associated with high post­ operative pain and the highest complication rate.7

In attempt to decrease drawback of hemorrhoidectomy, several studies tried a variety of surgical devices including surgical scalpel, scissors, monopolar cauterization, bipolar energy, and ultrasonic devices In general, there appears to be no definitive advantage of one over the other.8-12

Aigner  et  al  concluded  that  there  is  an

association    between    hypervascularization

Am-ShamsJSurg2014;7(2):341-346

and  the  incidence  of  hemorrhoidal   disease as they  found  that the terminal  branches  of the  superior   rectal  artery  in  patients  with hemorrhoidal    disease   had   a  significantly larger  diameter,  greater  blood  flow, higher peak   velocity    and            acceleration    velocity, compared to those ofhealthy volunteers.13,14

These  findings  may  explain  the  success rate  which  occurs  after  procedures  based on decreasing vascularity by hemorrhoidal artery ligation which can be done with or without Doppler guidance.

Pile suture is a simple method (introduced by Farag in 1978) in which three interrupted sutures   are   used   to   interrupt   the   blood flow  leading  to  initial  congestion  followed by gradual shrinkage of prolapsed hemorrhoids_15,16

According   to  sliding   anal  canal  lining theory       hemorrhoid       disease       develop when   the   supporting   tissues   of   the  anal cushions disintegrate leading to downward displacement ofthe anal cushions.17

Depending on this theory Hussein introduced  Ligation-anopexy  as a minimally invasive simple method to treat advanced hemorrhoids. This procedure was designed to restore fixation of the hemorrhoids cushions to the underlying internal sphincter, reduce hemorrhoids prolapse, and minimize the hemorrhoids blood flow.18

The aim ofthis study is to compare ligation­ anopexy and pile suture to explore the role of addition of anopexy to hemorrhoidal  ligation to decrease recurrence of symptoms.

Methods:

This is a randomized  controlled trial with prospective   data  collection  of  60  patients with grade III or IV hemorrhoid disease admitted to Unit of Colon and Rectal Surgery, Alexandria Main University Hospital.

Informed consent was obtained from each

patient. The study protocol was registered and approved  by the Committee  of Postgraduate Studies and Medical Research, Faculty of Medicine, University of Alexandria.

The study compared 30 patients undergoing

Ligation-anopexy (group I) versus 30 patients undergoing pile suture (group II) for advanced

hemorrhoidal disease, in which medical treatment failed. Patients with concomitant ano-rectal disorder were excluded.

Patients  of  group  I  underwent  ligation­

anopexy16   Figures (1-4)   while   group   II underwent pile suture according to Farag's technique18 with a suture passed through the mucous membrane at the proximal end of the internal haemorrhoids in order to occlude the superior haemorrhoidal vessels as they enter the  internal hemorrhoids,  and then a second suture  was  introduced   into  the  distal  end of the  internal  hemorrhoids  above the  level of the pectinate line, thus interrupting the connection between the internal and external haemorrhoidal  plexuses.  A third  suture  was placed between the previous two.19

Variables     noted     included     operating time, post-operative pain, time off work, complications, and recurrence of symptoms. Pain was assessed with visual analogue scale (VAS). Follow up was made in both groups for a period of twelve months.

Statistical analysis:

Statistical analysis was done using Statistical Package for Social Sciences (SPSS/version  21) software.

The  statistical  test  was  as  follow: Arithmatic mean, standard deviation, for categorized parameters Chai-square test was used. While for comparison between two groups  t-test  was used for  parametric  data. The level of significant was 0.05.

Results:

In this study the age ranged between 22 years to 77 years with mean age in group I was  42.6 ±14.04  and in group  II was  40.8

±11.17 years. There were 15 women  in the

ligation-anopexy  group and 13 women in the pile suture group.

Data    from    pre-operative    history     and

examination showed that there was no significant  difference  between  the  two groups regarding of complaint, duration of complaint, grade of haemorroidal disease, number  of  haemorroidal  columns  affected and associated co-morbidity Table (1).

The  operative  time  for  ligation-anopexy

Figure (1): A case of 4fh degree hemorrhoidal disease for ligation-anopexy.

Figure  (3):  Redundant  mucosa  is  pulled distally to be incorporated in the ligature.

Figure (2): Introduction of the Sims' speculum and suture to fix the mucosa and the submucosa to the underlying, internal anal sphincter.

Figure (4): At the end of the procedure.

-- Groupl    _...Groupll

6

5

4

1

0

Oay J

Oay2                      Oay3                      O•y7

Figure (5): VAS pain score in both groups.

group was insignificantly lower than that for pile suture group  with a mean of 18.3±4.12 minutes versus 22.83±7.05.  Mean follow up for group I was13.73±2.12 while for group II it was14.21±2.26 months.

Early follow up showed that post-operative pain in pile suture group was significantly higher at 1st post-operative day (2.43 ± 0.94 vs 4.97±1.65) and remained significantly higher till the end of first week (0.43 ± 0.63 vs1.07 ± 1.17) Figure (5).

Mean time needed for the patients to retum

to nonnal activity was slightly lower in group

1 (5.3  ± 1.54  days)  than  in  group  2 (6.90

± 2.14 days),  however  this was statistically insignificant.

Post-operative complications included tlu·ombosis which  occured  in  4  patients  of group II and responded to medical treatment. Temporary anal spasm occured in tlu·ee patients of group  I and two patients of group II. Longer follow up showed  that skin tags were the most common complication  in both groups as it occurred in 26.7% and 33.3% in group I and II respectively. The recurrence of symptoms  was significantly  higher after pile suture (16.7%) than after ligation-anopexy (3.3%) Table (2).

Table (1): Clinical data of both groups.

Table (2): Complications  and recurrence.

Discussion:

Our  study  compares between  two minimally mvastve   procedures for management  of   advanced   hemorrhoid disease; ligation-anopexy and pile suture. There were no significant  difference  between both   groups   regarding  demographic  data, pre-operative data and operative  time.

However  the  follows  up showed  that  the post-operative pain assessed by VAS was significantly  higher   after   pile   suture   than

after  ligation-anopexy along the whole first post-operative week  which may be due to the congestion that follows  pile suture.

A study on 41 patients treated  by hemorrhoidal artery  ligation or stapled haemorrhoidopexy  reported   postoperative pain on a VAS as 1.6 and 3.2 respectively at

7-day follow-up (p<0.001) and 0.2 and 1.0 respectively at 21-day follow-up (p=0.06).20

Sung et al reported post-operative pain after

Doppler  guided  HAL  comparable with  that

after pile suture in our study at the end of first day and first week.21 Dowidar et al reported that post-operative pain assessed by VAS was significantly higher after hemorrhoidectomy when compared with pile suture.l9

In  this  study  although  pain  was  higher after pile suture, there was no significant difference between the two groups regarding the  return  to  normal  activity  (5.3  vs.  6.9) days. In a systematic review of 17 studies on hemorrhoidal  artery ligation return to normal activity occurred between 2 and 3days after the procedure for most studies.22

Early follow  up  showed  that there  were no major complications; however thrombosis occurred in 13.2% of the patients after pile suture which can be explained by stagnation and congestion.  Thrombosis  was  associated by anal spasm in two cases. Anal spasm occurred in three patients after ligation­ anopexy this may be due to incorporation  of internal sphincter in the suture.

Postoperative      hemorrhoid     thrombosis

was  reported   in   18  (3.6%)   and  3   (3%) patients in the case series of 507 and 100 patients respectively. In both series HAL was performed without anopexy23,  24.

In two other  case series of 330 and 616 patients  in which  HAL was performed  with anopexy, post-operative thrombosis was reported in 1.6% and 2.1% of the patients respectively. So repositioning of the anal cushions by anopexy may decrease congestion that lead to post-operative thrombosis.

Long term follow up showed that incidence

of skin tags was 26.7% after ligation-anopexy and 33.3% after  pile suture.  Gupta reported skin tags in only 2.1% of their cases this may be because most ofhis 616 cases were grade II and III.

In this study one year follow  up showed

that recurrence of symptoms was significantly higher after pile suture as recurrence occurred in  five  patients  (16.7%),  while  recurrence occurred  in  only  one  patient  (3.3%)  after ligation-anopexy.   This   can   be   explained by the  fact  that  hemorrhoid  disease  is not caused by only simple increase ofvascularity which is attacked by pile suture but the main

pathology   is   disintegration   of   supporting

tissues of the anal cushions leading to downward displacement ofthe anal cushions which is corrected by ligation-anopexy.

In  a systematic  review  of 17  studies  on

hemorrhoidal artery ligation including 1996 patients reported recurrence of bleeding and prolapse in 6% (40/638)  and 8% (50/638) of patients respectively in 9 studies with follow­ up  of  less  than  1 year;  these  figures  were

10% (49/507) and 11% (46/427) respectively

in the 6 studies  with follow-up  of 1 year or more. Out of 17 studies in this systematic review  only  one  study  performed  anopexy after dearterialisation which may be the cause ofthis high rate ofrecurrence.22

Conclusion

Ligation-anopexy  1s a  simple,  safe, effective  method  for  management  of advanced hemorrhoidal disease with minimal complications and low recurrence rate. Anopexy may be important to decrease complications   and  recurrence  when  added to ligation for treatment of advanced hemorrhoidal  disease.

Reference

1-   Hemorrhoids: In: Colon and rectal surgery. Corman  I\.1L, ed.  5th  ed.  Philadelphia: Lippincott     Williams   &     Wilkins;   2004:

177-253.

2-   Brill AI, Fleshman JW, Ramshaw BJ, et al: :Nlinimally invasive procedures: What family physicians need to know. J Fam Pract 2005;54 [Suppl1]: S1-S24.

3-   Cataldo P, Ellis CN, Gregorcyk S, et  al: Practice parameters for the management of hemorrhoids (revised). Dis Colon  Rectum

2005; 48: 189-194.

4-   Madoff  RD,   Fleshman   JW:   American gastroenterological association technical review on the diagnosis and treatment of hemorrhoids. Gastroenterology 2004; 126:1463-1473.

5-   Arroyo A, Perez F, :Nliranda E, Serrano P, CandelaF, Lacueva J H: Open versus closed day-case haemorrhoidectomy: Is there any difference? lnt J Colorectal Dis 2004; 19(4):370-373.

6-   Syed AA, Agha TM, Mohammad J, Javeria I,  Akmal JS, Abdul G:  Outcome of  the rubber band ligation with :Nlilligan Morgan heamorrhoidectomy. J   Ayub   Med    Call Am-ShamsJSurg2014;7(2):341-346 Abbottabad 2010; 22(4): 56--60.

7-    Mac  Rae  HM,   McLeod   RS:  Comparison of   hemorrhoidal   treatment   modalities.   A meta-analysis.  Dis Colon Rectum 1995; 38:687-694.

8-    You SY, Kim SH, Chung CS, Lee DK: Open vs. closed hemorrhoidectomy. Dis Colon Rectum. 2005; 48: 108-113.

9-    Gencosmanoglu  R, Sad 0, Koc D, Inceoglu R: Hemorrhoidectomy: Open or closed technique?                     A    prospective,     randomized clinical  trial.  Dis Colon Rectum. 2002; 45:70-75.

10-  Arbman G, Krook H, Haapaniemi S: Closed vs open hemorrhoidectomy-is there any difference?   Dis  Colon  Rectum.  2000;  43:31-34.

11- Abo-hashem  AA,  Sarhan  A,  Aly  AM: Harmonic scalpel compared with bipolar electro-cautery                             hemorrhoidectomy:     A randomized controlled trial.lnt J Surg. 2010;8: 243-247.

12-  Chung CC, Ha JP, Tai YP, Tsang WW, Li MK: Double-blind, randomized trial comparing Harmonic               scalpel       hemorrhoidectomy, bipolar     scissors    hemorrhoidectomy,   and scissors excision: Ligation technique. Dis Colon Rectum 2002; 45: 789-794.

13-  Aigner F, Gruber H, Conrad F, Eder J, Wedel T, Zeiger B, Engelhardt V, Lametschwandtner A, Wienert V, Bohler U,Margreiter R, Fritsch H: Revised morphology  and hemodynamics of the anorectal vascular  plexus: Impact  on the course of hemorrhoidal disease. lnt J Colorectal Dis. 2009; 24:105-113.

14-  Aigner   F,  Bodner   G,  Gruber  H,  Conrad F,  Fritsch   H,   Margreiter   R,  Bonatti   H: The vascular nature of hemorrhoids. J Gastrointest Surg 2006; 10: 1044-1050.

15- Awojobi OA: Modified pile suture in the outpatient treatment of hemorrhoids. A preliminary report. Dis Colon Rectum 1983;26:95-97.

16-  Farag AE: Pile suture: A new technique for the  treatment   of  hemorrhoids.   Br  J  Surg1978; 65: 293-295.

17-  Thomson WH: The nature of haemorrhoids. Br J Surg 1975; 62: 542-552.

18- Hussein AM: Ligation-anopexy for treatment of advanced hemorrhoidal disease. DisColon Rectum 2001, 44:1887-1890.

19- Dowidar  N, Ebada A, AbouRayah F, Aboul­ Soud M: Pile suture technique for treatment of haemorrhoids versus ligation excision haemorrhoidectomy      a    randomized     trial evaluating clinical effects and anal sphincter manometry.   Egyptian  Journal  of  Surgery

2004; 23: 159-166.

20-  Festen S, van Hoogstraten MJ, van Geloven AAW,  et  al:  Treatment  of  grade  III  and IV   haemorrhoidal    disease   with   PPH   or THD.  A randomized  trial  on  postoperative complication                         and      short-term      results. International Journal ofColorectal Disease

2009;24: 1401-1405.

21-  Sung W, Ryung A, Soon S, Kwang H: Early Experience of Doppler-guided  hemorrhoidal artery ligation and rectoanal repair (DG-HAL& RAR)  for  the  treatment  of  symptomatic hemorrhoids.  J Korean Surg Soc 2010;  78:23-28.

22- Giordano P, Overton J, Madeddu F, et al: Transanal hemorrhoidal-dearterialization: a systematic review. Diseases of the Colon and Rectum 2009; 52: 1665-1671.

23-  Walega P, Scheyer M, Kenig  J, et al: Two­ center experience in the treatment of hemorrhoidal disease using Doppler-guided hemorrhoidal  artery  ligation:  Functional results            after    1-year   follow-up.    Surgical Endoscopy 2008; 22: 2379-2383. 

24-  Faucheron  JL, Gangner  Y: Doppler-guided hemorrhoidal artery ligation for the treatment of symptomatic hemorrhoids: Early and three year follow-up results in 100 consecutive patients.  Diseases of the Colon and Rectum 2008; 51: 945-949.