Open (Miligan Morgan) Haemorrhoidectomy versus Stapled Haemorrhoidopexy: A Comparative Study

Background: Haemorrhoidal disease, one of the most common anorectal disorders, when complicated, is a painful concern to the patient. Miligan Morgan haemorrhoidectomy is a commonly performed gold standard procedure for haemorrhoids with good results but is a very painful procedure. Stapled haemorrhoidopexy has emerged as a possible alternative promising lesser immediate post operative complications. Methods: Sixty patients between age group of 20-70 years with symptomatic haemorrhoidal disease planned for surgical technique were randomized into two groups: A stapled haemorrhoidopexy(SH) group operated on using PPH 03 kit and a Miligan Morgan (MM) group operated on using a standard open haemorrhoidectomy technique. Results: The mean operative time, average pain scores and consequent parenteral and oral Original Research Article Kumar et al.; BJMMR, 21(12): 1-7, 2017; Article no.BJMMR.33489 2 analgesics requirement was significantly lower in stapled group. There was no significant difference in immediate complications between the two groups. Duration of hospital stay was significantly lower in SH group and they returned to work significantly earlier and were more satisfied than the open group. Conclusion: Stapled haemorrhoidopexy is an effective procedure for haemorrhoids with minimal immediate complications but the cost is exorbitant.


INTRODUCTION
Haemorrhoidal disease, the hypertrophy of normal vascular cushions located inside the anus, that normally seal the opening and prevent leakage of gas or stools become worrisome, when, these cushions become engorged or the tissue prolapses into the anal canal due to engorgement of blood vessels and laxity of the supporting connective tissue [1].
The treatment of haemorrhoids dates back to antiquity suggesting that not a single method has stood the test of time. At present, surgery is indicated in treatment of Grade 3 and 4 haemorrhoids [2]. Miligan Morgan haemorrhoidectomy, by virtue of its cost effectiveness, is a commonly performed procedure for haemorrhoids, it has good results but is a very painful procedure resulting in prolonged hospital stay. The patient may also face complications like haemorrhage, urinary retention and late complications like stenosis or incontinence [3].
Stapled haemorrhoidopexy, a relatively novel technique, popularised by Dr Antonia Longo, with use of a circular stapler has revolutionized operative procedures over the last two decades but this procedure is not without complications. A stapling gun is an expensive instrument and though, the procedure has many short term benefits, but , has been reported in some studies to have higher recurrence rate in the long run. Serious complications like rectal perforation and recto vaginal fistula have also be seen in this procedure [4,5].
Several controlled trials like those conducted by Mehigan et al. [6], Zakaria [7] concluded that stapled haemorrhoidopexy is superior to Miligan Morgan haemorrhoidectomy in terms of post operative pain, duration of hospital stay and time to return to work. These results were supported by Yousuf, Ellabban and Salman [8, 9,10] in their respective randomized trials.
Major studies have been done in western countries but there is paucity of data in Indian literature, thus, the present study was done to compare Miligan Morgan haemorrhoidectomy and stapled haemorrhoidopexy on a set of predetermined parameters, in an Indian set up.

METHODS
A total of 60 patients were randomized to undergo either the stapled haemorrhoidopexy technique or the Miligan Morgan technique. Two groups were constituted: A stapled hemorrhoidopexy (SH) group (30), operated on using the PPH 03 kit (Ethicon Endo Surgery); and a Miligan Morgan(MM) group (30) operated on using a standard open haemorrhoidectomy technique. Patients with acute haemorrhoidal episodes with thrombosis, prior haemorrhoidectomy and intercurrent anal pathology (i.e fistula and/or fissure) were excluded from the study. Approval was taken from the ethical research committee based in Rajindra hospital, Patiala, India.
A detailed history was taken and general physical examination was done on each patient alongwith digital rectal examination, proctoscopic evaluation, preoperative investigations and pre anaesthetic check up. Informed consent was taken from all the patients.

OPERATIVE PROCEDURE [11]
Anaesthesia was of patients choice. Patients were given two phosphate enemas before the operation (one at night and other at the morning of surgery). All patients were given metronidazole (500 mg intravenously) at induction of anaesthesia. All operations were done in lithotomy procedure.
The operative procedure for Miligan Morgan group consist of holding the pile mass with an artery forceps and diathermy dissection and excision. The vascular pedicle was carefully ligated. A dressing sponge was placed in the anal canal on completion of the procedure.
The stapled procedure was done according to technique described here. The circular anal dilator with the transparent anal retractor was inserted upto the hilt and secured with 2 lateral stitches. After securing the circular anal retractor, the purse string anoscope was introduced through its center. A 2/0 monofilament suture on a tapered 5/8 th needle was used. By rotating the anoscope, only mucosa purse string suture was placed 4 to 5 cm above the dentate line that draws a circumferential ring of mucosal tissue into the stapling device. The excision of a 2 cm tissue ring and the simultaneous reanastomosing of the mucosa with 2 staple rows result in a circumferential surgical wound about 2 cm above the dentate line. Inspection of the staple line was done by a bivalve retractor and any bleeding points were stopped by electrocautery. A dressing sponge was placed in the anal canal at the end of the procedure. Precautions were taken not to include the muscular wall in the purse string suture. Vaginal mucosa was checked in female patients before firing the stapler to ensure that it is not tenting into the housing of the stapler.
Post operatively, both the groups received similar nursing care. Patients were discharged when the pain was controlled and home conditions permitted and were called for regular follow up in OPD for 1 month or any time in case of emergency.
The primary endpoints of the study was measurement of pain during 1 st 24 hours, 1 st motion, till 7 days and 10 days. Postoperative pain scores was measured using a 100 millimeters VAS (visual analogue scale). The secondary outcome measures were o perative time, use of analgesia, incidence of post operative complications, duration of hospital stay, time of first bowel, patient's satisfaction and time until return of normal activity.
Descriptive statistical analysis has been carried out in this study. Significance is assessed at 5% level of significance. Mann Whitney U test has been used to find significance of study parameters between two groups.

RESULTS
In this study maximum number of patients were in the age group of 31-50 years.    Table 4 shows the complications in early post op period (1 st week) in each of the groups (p=0.764 which is insignificant).
The hospital stay was significantly lower in stapled group (p=0.004) and return to work significantly earlier (in days) in stapled group (p=0.000) ( Table 5).
Patients were asked to rate their satisfaction into three categories: •

DISCUSSION
Miligan Morgan technique has been under the radar due to pain in early post operative period, prolonged hospital stay and delayed return to work. The Longo technique promises to circumvent these issues by resecting circumferential part of rectal mucosa and submucosa, offering better venous drainage, but this is a relatively newer technique, with most surgeons still in the learning curve.
In our study, maximum patients were middle aged and majority (75%) of them were males. Some studies show equal sex ratio. This may be due to the fact that majority of woman suffering from haemorrhoids fail to seek medical assistance due to social and cultural factors.
Duration of surgery is significantly lower in stapled group which is similar to observation of other studies. In our study, post operative pain was assessed using a visual analogue scale (VAS).The aim was to keep the VAS below 3 with adequate analgesia. The pain scores were significantly higher in the open group because raw area was present in somatic region below the dentate line.VAS score was less in stapled group resulting in less requirement of analgesic drug. However, Cheetham et al. [12] reported significantly more pain in stapled group .The pain was probably due to low staple line in their study.  The average time for passage of 1 st stool in the stapled and open group was 16.43 hrs and 23.00 hrs respectively. Delay in passage of stools in open group can be due to pain experienced by the patient. The passage of stool was associated with significant pain in open group. This also has been well documented in previous studies [13].
Postoperative complication rate was insignificant when compared in both groups. One patient had urinary retention in the open group for which indwelling catheterization was done. Post operative incidence of haemorrhage was similar in both groups which subsided after administration of an injection of tranexamic acid. This is well supported by literature [14]. Faecal incontinence in open group was present in two patients, it may be due to damage of some fibres of sphincter by cautery. No major complication was found in stapled group. Rare complications have been mentioned in literature. Molloy and Kingsmore [15] reported a case of severe retroperitoneal sepsis following stapler procedure. In our study, all patients received prophylactic antibiotics and no patient developed sepsis. There are 2 case reports of rectal perforation and one case of rectovaginal fistula after stapler haemorrhoidopexy [16,17]. Also acute intestinal obstruction due to closure of the rectum by purse string sutures has been reported [18]. These complications are suggested to have happened due to lack of experience and can be overcome.
As a late complication, in stapler group, one patient had faecal urgency. One patient complained of intermittent bleeding but was asymptomatic at the end of the month. One patient had pain on defecation which reduced with time. One had skin tag but otherwise didn't have any recurrence .In open group, persisting pain post surgery was seen in three patients, one of them had anal stenosis which was managed with anal dilatation followed by lateral internal sphincterotomy after 15 days. In comparative studies of both groups, no significant differences were seen. Most of the previous studies clearly show long term haemorrhoid recurrence after stapled procedure but the overall need of surgical and nonsurgical reintervention after two procedures was similar.
We observed that, the duration of hospital stay and time to return to work was significantly lesser for stapled group. This is in accordance to the earlier studies [19]. This can be attributed to the fact that open group is related to more pain and discomfort and passage of stool is also delayed. There is also a higher patient satisfaction in stapled group which is in agreement with earlier literature.
In our study,we noted that the cost of stapled haemorrhoidectomy was very high (400$ vs 110$). There are few studies that suggest stapled hemorrhoidopexy is more cost effective on basis of early discharge but, as hospital stay is not costly in our setup, so for our patients stapled hemorrhoidopexy is not cost effective.

CONCLUSION
Stapled haemorrhoidopexy is an effective procedure for haemorrhoids and has minimal immediate complications, with shorter duration of surgery, lesser post operative pain and need for analgesia, shorter duration of hospital stay and earlier return to work when compared with Miligan Morgan haemorrhoidectomy but the cost of stapled haemorrhoidopexy is exorbitant and cannot be offered to all patients. The long term complications of stapled haemorrhoidopexy are still unknown and it is a relatively novel concept with most surgeons still in learning curve.

CONSENT
As per international standard or university standard, patient's written consent has been collected and preserved by the authors.

ETHICAL APPROVAL
As per international standard or university standard, written approval of Ethics committee has been collected and preserved by the authors.

ACKNOWLEDGEMENT
We thank Dr Bimaljot Singh, Dr Ashish Sharma and Dr Malkiat Singh who provided insight and expertise that greatly assisted the research. We