|Year : 2022 | Volume
| Issue : 1 | Page : 24-28
Comparison of surgical outcomes in laser haemorrhoidectomy and stapler haemorrhoidopexy for grade II and III haemorrhoids – A prospective cohort study
UV Akshay Viswanath, Rojan Kuruvilla, P Sajan, Amal George, Jinto Augustine Thomas
Department of General Surgery, ASTER Malabar Institute of Medical Sciences, Kozhikode, Kerala, India
|Date of Submission||01-May-2022|
|Date of Decision||03-May-2022|
|Date of Acceptance||07-May-2022|
|Date of Web Publication||14-Jul-2022|
Dr. U V Akshay Viswanath
Department of General Surgery, ASTER Malabar Institute of Medical Sciences, Govindapuram, Kozhikode - 673 016, Kerala
Source of Support: None, Conflict of Interest: None
Background: Haemorrhoids often necessitate surgical intervention. Laser haemorrhoidectomy and stapler haemorrhoidopexy are two alternative techniques that may be employed for the resolution of symptoms. Aim: The current study aims to compare the two modalities of treatment in terms of post-operative pain, post-operative complications and recurrence at 6 months. Methodology: It was a hospital-based prospective cohort study done in the department of general surgery at a tertiary care centre. Patients were included if they were symptomatic with Grade II or III haemorrhoids in ano and underwent surgery in the same institute. Patients were excluded if they were <18 years of age, had co-existing anorectal diseases (perianal fistula, anal fissure or abscess), had a previous history of anorectal surgery or open haemorrhoidectomy, had a history of recurrent haemorrhoids, had regular use of medications such as analgesics or immunosuppressants, had a history of neurologic deficit or chronic pain syndrome, was unfit for surgery or anaesthesia, or if they were pregnant. Post-operative pain was evaluated using visual analogue scale. Results: Seventy-two patients were included in the study, and no one was lost to follow-up. The mean age was 51.8 (13.9) years and ranged from 22 to 77 years. Majority were males (80.6%). Post-operative pain was lower in the laser group at all time points. Surgical complications were slightly lower in the stapler group. Recurrence at 6 months of follow-up was noted in only one patient belonging to the stapler group. Conclusion: Laser haemorrhoidectomy has significantly lower post-operative pain, but stapler haemorrhoidopexy had lesser post-operative complications, though not statistically significant. Both surgical techniques have low recurrent rates.
Keywords: Complications, haemorrhoids, laser haemorrhoidectomy, recurrence, stapler haemorrhoidopexy
|How to cite this article:|
Akshay Viswanath U V, Kuruvilla R, Sajan P, George A, Thomas JA. Comparison of surgical outcomes in laser haemorrhoidectomy and stapler haemorrhoidopexy for grade II and III haemorrhoids – A prospective cohort study. Kerala Surg J 2022;28:24-8
|How to cite this URL:|
Akshay Viswanath U V, Kuruvilla R, Sajan P, George A, Thomas JA. Comparison of surgical outcomes in laser haemorrhoidectomy and stapler haemorrhoidopexy for grade II and III haemorrhoids – A prospective cohort study. Kerala Surg J [serial online] 2022 [cited 2022 Sep 24];28:24-8. Available from: http://www.keralasurgj.com/text.asp?2022/28/1/24/350888
| Introduction|| |
The prevalence of haemorrhoids in the general population is estimated to range from 2.9% to 27% globally. In India, it has been around 5%. The prevalence is equal between males and females, but males are more likely found to be seeking treatment. The peak incidence of the disease occurs between 45 and 65 years. The treatment options for symptomatic haemorrhoids have included conservative medical management, non-surgical treatments and various surgical techniques depending on degree and severity of symptoms., The various non-surgical treatments include rubber band ligation, injection sclerotherapy, cryotherapy, infrared coagulation, laser therapy and diathermy coagulation for haemorrhoids of grade I to III. The most common complication in non-surgical management is pain. Surgical management is usually warranted in case of failure of the non-surgical treatments. Milligan-Morgan or open haemorrhoidectomy is considered the gold standard surgery. Recently, stapled haemorrhoidopexy has become very popular due to lesser pain and healing time. The common early complications of surgery are pain, urinary retention, secondary haemorrhage and abscess formation. The late complications are anal fissure, anal stenosis, stool incontinence, perianal fistula and recurrence of the disease. Laser treatment has an advantage of easy and efficient application, non-invasive, painless and reduced the need of pharmaceutical drugs, drug interactions and their side effects.
The selection of treatment for haemorrhoids is always a matter of debate. Each of the available treatment options has its merits and demerits. In our hospital, stapled haemorrhoidopexy and laser haemorrhoidectomy are the two treatment methods commonly practised. As a matter of evidence, it is necessary to compare the efficacy of both these modalities in terms of complications, post-operative pain and recurrences. Hence, a prospective comparative study was undertaken to get an insight into the better modality among the two in terms of post-operative pain, complications and recurrences after 6 months of follow-up.
| Methodology|| |
The prospective observational study was conducted in the Department of Surgery in a 600-bedded tertiary care centre for 12 months, from June 2019 to May 2020. Patients included were symptomatic with Grade II or III haemorrhoids in ano and underwent surgery in the same institute. They were excluded if they were <18 years of age, had co-existing anorectal diseases (perianal fistula, anal fissure or abscess), had previous history of anorectal surgery, open haemorrhoidectomy or recurrent haemorrhoids, had regular use of medications like analgesics or immunosuppressants, had history of neurologic deficit or chronic pain syndrome, unfit for surgery or anaesthesia, or were pregnant. The study was approved by the institutional ethics committee of the institute. Confidentiality was maintained.
The sample size was calculated based on the expected levels of post-operative complications based on previous pilot data from the same hospital. Assuming post-operative bleeding at 5 days to be found to 20% of patients after laser haemorrhoidectomy and in none of the patients with stapler haemorrhoidopexy, the same size was calculated to be 36 in each arm. Unit I routinely performed stapler haemorrhoidopexy whereas Unit II performed laser haemorrhoidectomy. Eligible participants were consecutively enrolled in the study till sample size was reached. Written informed consent was taken from all participants prior to enrolment. A predefined pro forma was used to collect the socio-demographic characteristics and the clinical profile. Post-operative pain was evaluated using the visual analogue scale (VAS) 0–10, with 0 corresponding to 'no pain' and 10 representing 'maximum pain'. The pain was assessed post-operatively on days 1, 7, 14 and 30 following the surgery. Similarly, they were followed up for complications such as secondary haemorrhage, proctitis, pain, urinary retention along with days taken to return to work following surgery. Patients were followed up after 6 months to note recurrence. Data were analysed using SPSS V21 for IBM (SPSS V21 for IBM, India) for windows. Continuous variables such as age, VAS score and days of return to normal activity are presented as mean (standard deviation [SD]). Categorical variables such as gender, symptoms and complications are presented as frequency and percentages. Chi-square test was used to determine the association between categorical variable and the type of surgery. Repeated measures ANOVA were used to determine the association between VAS scores over time and the type of surgery. A P < 0.05 was considered statistically significant.
Surgical techniques included Stapler haemorrhoidopexy. A gentle per rectal examination and anal dilation were performed. The external device (transparent anoscope) of PPH stapler was fixed to the cutaneous margin which resulted in reduction of the prolapsed haemorrhoids. Next, a transparent retractor was used to insert a 2/0 propylene purse-string suture circumferentially, with submucosal bites over the lower rectum about 2 cm above the dentate line. The anvil (head) of the stapler was introduced beyond the purse-string suture and then the purse string was tied over the stem firmly. The stapler was then closed, incorporating the prolapsed haemorrhoidal tissue into its cup by gradually tightening the screw. After confirming that adequate tissue was incorporated and the vaginal wall in female patients is free (by PV examination), the stapler was fired. Then, the stapler was taken out with the doughnut. Haemostasis along the stapler line was then confirmed and if required, cautery or a 3–0 vicryl suture was used.
Laser haemorrhoidectomy was performed using the 1470 nm diode laser (Energy: 8 watts). A dedicated disposable proctoscope (23 mm in diameter) was introduced into the anal canal. A small incision was made at the base of each haemorrhoid by the laser port into the haemorrhoidal plexus taking care not to injure or burn the mucosa or the internal sphincter. Laser shots (150–350 joule/segment, depending on the size of haemorrhoids) were delivered through the optic fibre in a pulsed fashion to reduce undesired degeneration of the periarterial normal tissue. The depth of shrinkage of haemorrhoidal tissue can be controlled by the power and duration of the laser beam. The mechanism of action of the laser was the absorption of the energy by the tissue thereby causing destruction of the haemorrhoid vessels resulting in fibrotic shrinkage and reduction of haemorrhoidal tissue.
| Results|| |
Seventy-two patients were included in the study, and no one was lost to follow-up. The mean age of the patients was 51.8 (13.9) years with a range from 22 to 77 years. Majority of the patients were males (80.6) with a male: female ratio of 4.1:1. A comparison of baseline characteristics of the study participants between the two groups is shown in [Table 1]. Both groups were comparable in terms of baseline attributes.
|Table 1: Comparison of baseline characteristics across the two groups (n=72)|
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[Figure 1] shows the trend of mean pain scores in the post-operative period. The pain scores were lower in the laser group on all days (2.8 vs. 3.8 on day 1; 1.4 vs. 2.5 on day 7; 0.6 vs. 1.1 on day 14 and 0 vs. 0.6 on day 30) and the difference was found to be statistically different (P < 0.001).
|Figure 1: Comparison of post-operative pain (visual analogue scale score) between the laser haemorrhoidectomy and stapler haemorrhoidopexy group (n = 72)|
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[Figure 2] shows the difference in rates of complications between the two groups. 44.4% of participants had any complication in the laser group whereas 30.6% had complications in the stapler group, and this difference was not found to be statistically different (P = 0.224). The incidence of specific complications was also not statistically different between the groups. The mean (SD) time taken to return to work was 6 (5.1) days in the laser group and 4.7 (3.8) days in the stapler group (P = 0.205). There was no significant difference in early review (due to unexpected complications) between the laser haemorrhoidectomy and stapler haemorrhoidopexy groups (11.1% vs. 16.7%; P = 0.496).
Recurrence at 6 months of follow-up was noted in only one patient belonging to the stapler haemorrhoidopexy group. Difficulty in passing stools was reported by two patients and two patients had skin tag at 6 months of follow-up. Occasional bleeding was reported by 10 patients.
| Discussion|| |
The treatment for haemorrhoids is primarily decided by the subjects' perception of the symptoms and the choice of the treating surgeon based on the classification of haemorrhoids. Availability of multiple options has led to a confusion about the optimal technique for the treatment of haemorrhoids. Moreover, the problem of post-operative pain has not been explored in detail. Although there are evidences that both stapled and laser haemorrhoidectomy result in less post-operative pain and other complications, there are very few studies comparing both the procedures. Our study was undertaken as a preliminary step to determine the utility of both procedures in our setting.
The mean age of the participants in our study was 52 years and this follows a Gaussian distribution in which the peak incidence of the disease occurs between 45 and 65 years after which it starts declining. Similar findings have been reported by various studies conducted across the globe.,,,,,, As the age increases, there is weakening of supporting connective tissue and old age acts as a predisposing factor. However, the reason for decline in the incidence of the condition beyond 65 years is not well understood.
Males were affected more in our study as compared to the females (4.1:1). This finding is consistent with the available literature till date and this male preponderance might be attributable to the fact that females tend not to seek treatment until the severity of symptom increases.,,,,,,,,, However, anatomically and pathologically, both have similar prevalence of the disease condition.
The most common presentation was bleeding in 93% of the participants followed by pain in about half of the patients. Various authors have shown that bleeding per rectum was the predominant symptom.,,,, However, George et al. and Thejeswi et al. have reported mass per anus followed by pain as the predominant symptom.,
Post-operative pain is one of the reasons for the patients not availing surgical management in case of haemorrhoids. The major advantage of laser haemorrhoidectomy and stapler haemorrhoidopexy is that both the procedures result in comparatively lesser post-operative pain. In an open procedure, there will be a large raw area after excision of the haemorrhoids with exposure of the nerve endings raising the intense sensation of pain. Stapler haemorrhoidopexy involves resection of a circular part of mucosa and submucosa containing the haemorrhoids with primary edge to edge anastomosis decreasing the nerve endings exposure compared to the open procedure. In laser haemorrhoidectomy, there will be minimal wounds in relation to the base of the haemorrhoids and hence lesser pain. Our study showed that the laser procedure had significantly lesser pain on day 1, 7, 14 and 28 when compared to the stapler haemorrhoidopexy. This is similar to studies by Eskandaros et al., and Poskus et al.,, Naderan et al. and Maloku et al., comparing laser and open haemorrhoidectomy showed that laser procedure resulted in significantly lesser post-operative pain when compared to the open procedure., Similarly, Agarwal et al. and Kishore et al. showed that the stapled group had lesser post-operative pain when compared to the open haemorrhoidectomy., Parker also had similar findings as the stapler sutures healed faster when compared to the conventional procedure.
Secondary haemorrhage and post-operative infection were similar between the two procedures and it is consistent with the available literature. However, proctitis was significantly higher in patients who underwent laser haemorrhoidectomy when compared to the stapler haemorrhoidopexy group. None of the patients in the stapled group developed proctitis. Similarly, days of return to work were also similar between the two groups.
Dawood et al., Kishore et al., Crea et al., and Jayaraman et al. reported that recurrence was common among the stapled group.,,, In our study, stapled group had recurrence in one patient but it was not statistically significant. Eskandaros et al. showed that three (7.5%) patients in SHP and four (10%) patients in LHP had recurrence. The recurrence rate depends upon the degree of haemorrhoidal prolapse before the operation and degree of recanalization following surgery and it is reported that recurrence is a matter of concern among the stapler haemorrhoidopexy group. Two patients in the stapled group experienced urinary retention. However, incontinence was not reported by any patient and one patient in each group had prolapse. Eskandaros et al. showed that the urinary retention was more among the stapled group when compared to the laser group.
The study has several strengths. It is one of the few studies conducted on the topic in India, and the first study from the state of Kerala, to the best of our knowledge. It provides insight on the right choice of the right surgical method to be taken up in terms of post-operative pain. None of the patients were lost to follow-up and were successfully assessed for recurrence at 6 months. The study also has some weaknesses. By design, since it was an observational study and not a randomized trial, there can be unknown confounders that influenced the results. In the specific setting, since the two procedures were performed by different sets of surgeons, characteristics of the operating doctor can also have had some implications in the surgical outcome, which has not been accounted for. As a single-centre study, study results might also be affected by hospital protocols and methods followed. A longer duration of follow up might have led to capturing more recurrent cases in either group. Cost of surgery was not assessed for the groups although that is also an important factor in clinical decision making.
| Conclusion|| |
The two surgical modalities are comparable in terms of overall post-operative complications, days taken to return to work and recurrence. Laser haemorrhoidectomy has lower post-operative pain compared to stapler. Costing studies may be explored in the future to look at the cost-effectiveness of the two modalities as an additional indicator for clinical decision-making.
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Conflicts of interest
There are no conflicts of interest.
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