Introduction

Haemorrhoids means blood flowing (Greek: Haema=blood and Rhoos=flowing). The latin word “pila” from which the word “pile” is derived, actually means a ball. Since ancient times haemorrhoids have been the most disturbing diseases. Haemorrhoids represent pathological changes in the anal cushions, a normal component of the anal canal involved in aiding evacuation of stool and fine-tuning of anal continence. These pathological changes include rupture of the supporting connective tissue within the cushions, resulting in enlargement of the vascular plexus [1,2].

It has been suggested that the ideal treatment of haemorrhoids should be minimally invasive, painless, safe and effective with minimal cost [3]. Grade III and IV haemorrhoidal disease (Goligher classification) responds more favourably to surgical treatment [4]. Traditional Open Haemorrhoidectomy (OH) is still the gold standard operation but it is associated with significant postoperative pain and a small risk of injury to the anal sphincter complex [5].

Recently, stapled haemorrhoidopexy has been advocated as an alternative technique that is better in all aspects. Besides the improvement in the cosmetic appearance, there is lesser hospital stay (90% of stapled and 55% of open haemorrhoidectomy having a stay of less than 24 hours [6-8]. There is also marked reduction in the pain after operation (95% less) 11 and as there is negligible bleeding in the postoperative period (6% of patients having post operative bleeding), so there is no need to pack the wound [9].

Stapled Hemorrhoidopexy (SH) has been introduced since 1998 [10]. A circular stapling device is used to excise a ring of redundant rectal mucosa proximal to hemorrhoids and resuspend the hemorrhoids back within the anal canal. Apart from lifting the prolapsing hemorrhoids, blood supply to hemorrhoidal tissue is also interrupted. A recent meta-analysis comparing surgical outcomes between SH and hemorrhoidectomy, which included 27 randomized, controlled trials with 2279 procedures, showed that SH was associated with less pain, earlier return of bowel function, shorter hospital stay, earlier return to normal activities, and better wound healing, as well as higher degree of patient satisfaction.

The stapled haemorrhoidopexy procedure removes redundant mucosa but cannot remove the skin covered external components of grade IV prolapse. Surgeons must be prepared to do a hybrid operation that combines the stapled procedure with a diathermy excision of the external component. In patients with excessive mucosal prolapse, the capacity of the stapler device to excise the mucosa may be exceeded. It has been proposed to use two staplers in this situation which gives significantly better result [11]. Others have proposed lowering the staple line and even including anoderm in the excision with improved result [12], or applying additional traction sutures to segments with more prominent mucosal prolapse [13].

Though the advantages of stapled haemorrhoidopexy over conventional procedure was studied and reported by numerous researchers, the retrospective observational cohort study of initial outcomes after a double row and triple row stapler surgeries remain are studied in our institution. However, prospective randomised controlled trial of initial outcomes along with late outcomes like -Chronic pain, recurrence, stricture formation are not done earlier, for which follow up of patients was done for 6 months.

Table 1: Statistical analysis of various parameters.

Material and methods

This is a Prospective randomised controlled trial carried out in the Department of General Surgery of Artemis Health Institute, Gurgugram, Haryana, during the period from April 2021 to October 2022. The hospital caters to population from Gurugram and neighbouring districts and the clientele comprises of patients from various different socio-economic background. Institute ethical committee clearance certificate was sought and obtained before the study was begun and written informed consent was obtained from all the study participants before including them in the study.

Inclusion criteria: 1) Male and female patients who are in between 18-90 years of age. 2) Patients with Grade-2 and Grade-3 hemorrhoids.

Exclusion criteria: 1) Any pregnant female patient or with suspected pregnancy at the time of screening. 2) Patients whose tissue have undergone multiple injections of sclerosing agents for haemorrhoids. 3) Patients with active infections or with a history of infections requiring antibiotics at the intended operative site within 30 days prior to the planned surgery date. 4) Patients who have taken anti-coagulant or anti-platelet therapy within 7 days prior to the planned date of surgery. 5) Patient unfit for surgery.

Computer based Randomized Control Trial was done. In our study, 100 patients were enrolled (50 patients in two groups) In group-1 two rows stapler stapler device was used while in group-2 three rows stapler device was used after agreeing to participate and after obtaining a proper informed consent. Patients were randomly allocated to one or more interventions and were followed until a finite date or the occurrence of one or more outcomes of interest. Their decision was kept secret in an envelope and was not mentioned in the data collected for the purpose of the study. The data was analyzed at the end of data collection. The envelope was opened and the groups were encrypted for the purpose of analysis. Statistics and comparisons were made which were ultimately decrypted to draw the final results. Computer based randomization was done.

Patients were operated via Stapler Hemorrhoidopexy technique. Standard technique was used, anaesthesia (spinal or general anaesthesia) was administered to all patients prior to surgery. Patients were placed in extended lithotomy position. Digital and proctoscopic examination was done using lignocaine jelly. Analport was placed and was fixed using silk suture. Stapler gun was used as per surgeon’s preference. A purse string suture was taken 3 cms above dentate line. Anvil of stapler gun was inserted beyond purse string suture and suture was tightened. Stapler was tightened up to the indicated mark on gun and fired. Stapler was opened and removed along with the haemorrhoidal “Doughnut”. Doughnut was examined for completeness. Staple line was examined for hemostasis and any hemostatic sutures if required were taken.

Data collection was done as per the proforma, details regarding their demographics, clinical symptoms, examination findings and pre-operative investigations were noted down. Preoperative pain scoring was done using Visual Analog Scale (VAS). Intraoperative data was collected including the operative duration, blood loss, and any inadvertent events during the operation. Intra-op blood loss was measured by absorption capacity of gauze piece. Postoperative pain score (VAS) was noted at 12 hours, 18 hours and 24 hours of the operation. The patients were discharged the next day, before which the operative site was discharged and were advised to follow up at 1 week, during which pain score (VAS), any complaints/symptoms and examination findings were noted down. Monthly follow up was done for 6 months.

Results

A total of 100 patients underwent stapled haemorrhoidopexy between april 2021 to october 2022. In three rows stapler group there were 38 male and 12 female patients, mean age of patients was 25. In two rows stapler group there were 36 male and 14 female patients, mean age of patients was 25. Mean operating time for three row stapler group was 35.7±7.2 mins and two rows stapler group were 36.1±8 mins. Use of hemostatic sutures in three row stapler group was needed for 10 patients and in two rows stapler group for 23 patients.

Early post-op bleeding is higher in two rows stapled group (69.7%) compared to three rows stapled group (30.3%). Late post-op bleeding is also higher in two rows stapled group (Three patients on post op day 3 and one patient on post op day 4), while none of them in 3 rows group had late post op bleed.

Higher proportion of patients in 2 rows group had higher VAS score on post op day 7 as compared to 3 rows group. Also, this difference was found to be statistically significant (p value – 0.001).

Higher proportion of patients in 2 rows group developed recurrence, as compared to patients in 3 rows group (p value– 0.05). One patient in three rows group and six patients in two rows group had recurrence.

Duration of hospital stay was considerably higher for patients in 2 rows group as compared to patients in 3 rows group (p value -0.027).

The operative blood loss and application of hemostatic suture was more in the patients who were operated by two rows stapler as compared to the patients who were operated by three rows stapler. Patients in whom hemostatic sutures were applied, were kept in hospital for longer duration for observation to look for any reactionary haemorrhage.

However, no significant difference was noted between the two groups in post-op pain at 12, 18 and 24 hours. Also, no significant difference was noted in operation duration, and late complications like chronic pain and stricture formation.

The complications like early post-op bleeding, late post-op bleeding, and late complication like recurrence rate are higher in two rows stapler group compared to three rows stapler group.

The late post-op pain (at 1st follow up) was higher in two rows stapler group as compared to three rows stapler group. Pain was present mostly in those patients who needed application of hemostatic sutures.

Conclusion

Currently, several therapeutic modalities are available for the treatment of haemorrhoids. It largely depends on the severity and location of the haemorrhoids. Low grade (grade 2) haemorrhoids are usually managed by non-invasive methods like Rubber Band Ligation (RBL). The RBL procedure can be performed in an outpatient setting (may require several sittings) but is considered safe and preferred by patients, and yields a success rate of 7097% [57]. Doppler technology to identify and ligate 3-6 hemorrhoidal vessels has shown to result in lower recurrence rates than RBL, yet its association to increased post-operative pain and it being an invasive procedure is not practiced widely. For grade 3 prolapsing haemorrhoids, excision has been considered standard of treatment. With the advent of stapler haemorrhoidal procedure, the ease of availability of stapler devices, the variety of options available and increasing expertise in the technique, the current era has seen the stapler procedure being performed at an increasing rate in the last decade. However, even the stapler procedure is not free from complications. Postoperative pain has always been a fear-factor in patients with haemorrhoids. Pain is the major concern, which makes patients reluctant to undergo surgical procedure.

In our comparative analysis, we found that both two rows stapler and three rows stapler are safe and effective procedures for haemorrhoids. However, significant difference was noted in the operative blood loss and outcome parameters like hospital stay, application of hemostatic suture and complications like early post-op bleeding, late post-op bleeding, pain (at 1st follow up) and late complication like recurrence.

The operative blood loss and application of hemostatic suture was lesser in the patients who are operated by three rows stapler compared to the patients who are operated by two rows stapler. Early post-op bleeding is higher in two rows stapled group (69.7%) compared to three rows stapled group (30.3%). Late post-op bleeding is also higher in two rows stapled group (Three patients on post op day 3 and one patient on post op day 4), while none of them in 3 rows group had late post op bleed. Higher proportion of patients in 2 rows group had higher VAS score on post op day 7 as compared to 3 rows group. Also, this difference was found to be statistically significant (p value – 0.001). Higher proportion of patients in 2 rows group developed recurrence, as compared to patients in 3 rows group (p value– 0.05).

Duration of hospital stay was considerably higher for patients in 2 rows group as compared to patients in 3 rows group (p value -0.027). The operative blood loss and application of hemostatic suture was more in the patients who were operated by two rows stapler as compared to the patients who were operated by three rows stapler. Patients in whom hemostatic sutures were applied, were kept in hospital for longer duration for observation to look for any reactionary haemorrhage.

However, no significant difference was noted between the two groups in post-op pain at 12, 18 and 24 hours. Also, no significant difference was noted in operation duration, and late complications like chronic pain and stricture formation.

The complications like early post-op bleeding, late post-op bleeding, pain (at 1st follow up) and late complication like recurrence rate are higher in two rows stapler group compared to three rows stapler group, however further future studies with larger sample sizes are needed to verify the results in the longterm periods.

The late post-op pain (at 1st follow up) was higher in two rows stapler group as compared to three rows stapler group. Pain was present mostly in those patients who needed application of hemostatic sutures. Probably due to involvement of deeper tissue or taking the hemostatic suture too close to dentate line. However, further future studies with larger sample sizes are needed to verify the results.

Declarations

Ethical approval: The study was approved by the Institutional Ethics Committee.

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