Affiliations
doi: 10.29271/jcpsppg.2025.01.23ABSTRACT
Objective: To compare the outcomes of open versus Ligasure haemorrhoidectomy.
Study Design: Randomised controlled trial.
Place and Duration of the Study: Department of General Surgery, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan, from September 2024 to February 2025.
Methodology: A total of 60 patients with haemorrhoids were included. They were randomly divided into Group A (LigaSure® Haemorrhoidectomy) and Group B (Open Haemorrhoidectomy). The outcomes of operative procedures, including surgery length and post- operative pain score, were compared using the Mann-Whitney U test. Volume of blood lost during surgery was compared using the independent t-test, and pain severity was assessed and compared between the groups using the Chi-square test.
Results: In this study, 60 patients were included and divided into two groups. Median age was 32.00 (Interquartile range [IQR]: 54.00–23.00) years. There were 27 (45.00%) male and 33 (55.00%) female patients. Median body mass index (BMI) was 31.60 (IQR: 34.50–21.70) kg/m2. In the open haemorrhoidectomy group, median surgery length and mean loss of blood during surgery were 40.50 (IQR: 51.00–29.00) minutes and 116.80 ± 13.67 ml, while in LigaSure® group, these were 32.50 (IQR: 50.00–25.00) minutes (p = 0.004) and 84.36 ± 14.32 ml (p <0.001), respectively. There was no significant difference based on 24-hour follow-up median pain visual analogue scale (VAS) scores between the groups (p = 0.440).
Conclusion: LigaSure® improves intraoperative parameters significantly, but it has no benefit over the conventional open procedure based on postoperative pain.
Key Words: Haemorrhoids, Operative procedures, Outcome, Surgical blood loss, Visual analogue scale.
INTRODUCTION
Maintenance of the continence of the anus is achieved anatomically by several factors amongst which one of the most important structures that serves this purpose are haemorrhoids.1 These vascular cushions are made-up of a combination of various tissue types including vascular, muscular, and loose connective tissue.2 Various aetiologic factors can cause haemorrhoids but the pathophysiological mechanism is the same which is the prolonged strain on veins in the anal canal by a variety of factors.3,4
Clinically, haemorrhoids are graded into four severities, with degrees one and two being treated through minimally invasive procedures, while higher degree haemorrhoids, graded as degrees three and four, are treated through operative procedures.5
In the case of operative haemorrhoid management, two common approaches used globally are open haemorrhoidectomy and a modern option of LigaSure® haemorrhoidectomy. However, when different outcomes are compared between these two operative procedures, there is some degree of uncertainty regarding the question that which procedure is better than the other.6
Haemorrhoids are highly common in the general population, irrespective of geographical and economic conditions, with prevalence ranging from 4.4 to 38.93% in different countries of the world and a prevalence of 47.9% in Pakistan.7,8 This commonality, however, needs a high level of availability of the operative facilities to counteract the impact of this condition on the lives of the general population. Contrary to this, the availability of modern instrumentation such as LigaSure® is not as common as this disease is, and most patients are treated through conventional open haemorrhoidectomy.
This study was conducted with the aim to compare the outcomes of open versus Ligasure® haemorrhoidectomy in local population to see if the conventional open haemorrhoidectomy provides comparable outcomes to LigaSure® or is it necessary to equip at least the secondary care hospitals with surgical capabilities with LigaSure® to maximise the achievement of better outcomes of haemorrhoidectomy.
METHODOLOGY
This randomised controlled trial (IRCT# 20250117064410N1) was conducted at the Department of General Surgery, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan, from September 2024 to February 2025, after getting approval from the Hospital’s Ethical Committee (Ref. No: 0011/198/MED/ DGKMC). Sample size calculation was performed using the OpenEpi sample size calculator using the following formula:
Sample size calculation was performed by using a confidence level of 95%, power of 80%, anticipated population mean blood loss values in LigaSure and open haemorrhoidectomy groups of 83.59 ± 34.34 ml and 124.84 ± 37.56 ml, respectively.9 This gave a sample size of 60 (30 in each group). The study sample was selected by using the non-probability consecutive sampling technique.
All patients aged between 25 and 65 years of either gender, who planned to undergo surgery for grade III or IV haemorrhoids, were included. Patients with recurrent haemorrhoids, rectal carcinoma, and patients with thrombosis of haemorrhoids were excluded. Before inclusion in the study, written informed consent was obtained from every patient. After that, baseline characteristics including age (years), gender (male/female), body mass index [BMI], obesity, and grade of haemorrhoids (III / IV) were documented. Group allocation was performed randomly through a lottery method using sealed opaque envelopes. In Group A (n = 30), patients were assigned to undergo LigaSure® haemorrhoidectomy, while in Group B (n = 30), patients were assigned to undergo open haemorrhoidectomy. Patient selection process and study progression are demonstrated in the CONSORT patient flow diagram in Figure 1.10
Figure 1: CONSORT patient flow diagram.
All surgical procedures were performed as per institutional protocol by a consultant surgeon with ≥5 years of post-fellowship experience. All the procedures were performed under general anaesthesia, which was provided by a consultant anaesthesio- logist with a minimum of three years of experience. To avoid any bias, all the patients of both groups were provided similar pre- operative and postoperative care as per the protocol of the hospital. Additionally, standardised steps were followed for performing the operative procedure on haemorrhoids. The only difference between the operative procedures was in the methodology of haemorrhoid excision. In Group A (n = 30), open haemorrhoidectomy was performed in which haemorrhoids were excised using diathermy, followed by pedicle ligation, while in Group B (n = 30), LigaSure® haemorrhoidectomy was performed and excision was achieved by using LigaSure®, which is a special haemostatic bipolar electro-thermal device.
Outcomes of the two operative procedures for haemorrhoids that were assessed in this study were surgery length (time in minutes from induction of anaesthesia to extubation of endotracheal tube which was recorded by nursing staff using a stopwatch), intraoperative blood loss (sum of the amount of blood in ml, which was collected in graduated bottles and pre-weighted surgical sponge, 1-gram increase = 1 ml blood loss), and postoperative pain (graded 24-hours after surgery using visual analogue scale (VAS) score 0–10, where 0 was defined as no pain and 10 as worst bearable pain). Pain assessment was performed by the surgeon who was not aware of the type of operative procedure performed on the patient to avoid operator bias. Appropriate treatment was provided to patients with pain as per the hospital’s protocol. Hospital discharge was decided by the visiting surgeon once there was no active bleeding and the patient was pain-free.
Data were analysed using the Statistical Package for Social Sciences (SPSS) version 22. Quantitative variables (age, BMI, surgery length, and pain score) were presented as median and interquartile range (IQR) after checking the normality of data by the Shapiro-Wilk’s test, which showed that these were not distributed normally. Blood loss was distributed normally and was represented using mean ± standard deviation (SD). Qualitative variables (gender, obesity, haemorrhoid grade, and severity of pain after surgery) were presented as frequencies and percentages. Blood loss was compared between the groups using the independent t-test. Surgery length and pain score were compared between the groups using the Mann-Whitney U test. Severity of pain after surgery was compared between groups using the Chi-square test. A p-value of ≤0.05 was considered statistically significant.
RESULTS
In this study, 60 patients were included. Median age was 32 (54–23) years. There were 27 (45%) male and 33 (55%) female patients. Median BMI was 31.60 (34.50–21.70) kg/m2. Thirty (50%) patients suffered from obesity. Grade III haemorrhoids were found in 30 (50%) patients, and grade IV in 30 (50%) patients. Baseline characteristics are compared between the groups in Table I.
Table I: Comparison of baseline characteristics between the groups (n = 60).
|
Parameters |
Open haemorrhoidectomy (n = 30) |
LigaSure® haemorrhoidectomy (n = 30) |
p-values |
|
Median age |
32.00 (54.00–23.00) years |
34.50 (54.00–23.00) years |
0.377* |
|
Gender Male Female |
12 (40.00%) 18 (60.00%) |
15 (50.00%) 15 (50.00%) |
0.436† |
|
Median BMI |
31.70 (34.50–21.90) kg/m2 |
29.50 (34.50–21.70) kg/m2 |
0.386* |
|
Obesity |
18 (60.00%) |
12 (40.00%) |
0.121† |
|
Grades of haemorrhoids III IV |
15 (50.00%) 15 (50.00%) |
15 (50.00%) 15 (50.00%) |
>0.99† |
|
*Mann-Whitney U test. †Chi-square test. |
|||
Table II: Comparison of intraoperative parameters between the groups (n = 60).
|
Parameters |
Open haemorrhoidectomy (n = 30) |
LigaSure® haemorrhoidectomy (n = 30) |
p-values |
|
Median surgery length |
40.50 (51.00–29.00) minutes |
32.50 (50.00–25.00) minutes |
0.004* |
|
Mean loss of blood during surgery |
116.80 ± 13.67 ml |
84.36 ± 14.32 ml |
<0.001⁋ |
|
* Mann-Whitney U test. ⁋ Independent t-test. |
|||
Table III: Comparison of 24 hour postoperative pain VAS and pain severity between the groups (n = 60).
|
Parameters |
Open haemorrhoidectomy (n = 30) |
LigaSure haemorrhoidectomy (n = 30) |
p-values |
|
Median VAS |
2 (6–0) |
2 (5–0) |
0.440* |
|
Pain severity None Mild Moderate Severe Worst bearable |
8 (26.67%) 13 (43.33%) 9 (30%) 0% 0% |
5 (16.67%) 20 (66.66%) 5 (16.67%) 0% 0% |
0.190† |
|
* Mann-Whitney U test. †Chi-square test. |
|||
In the open haemorrhoidectomy group, median surgery length and mean loss of blood during surgery were 40.50 (51.00– 29.00) minutes and 116.80 ± 13.67 ml, respectively while in LigaSure® haemorrhoidectomy group, these were 32.50 (50.00– 25.00) minutes (p = 0.004) and 84.36 ± 14.32 ml (p <0.001), respectively. Intraoperative parameters are compared between groups in Table II.
At 24-hour follow-up, median pain VAS in the open haemorrhoidectomy group was 2.00 (6.00 – 0.00), while in the LigaSure® haemorrhoidectomy group it was 2.00 (5.00 – 0.00) (p = 0.440). Comparison of 24-hour postoperative pain VAS and pain severity between the groups is given in Table III.
DISCUSSION
Amongst the most common operative procedures performed globally, haemorrhoidectomy is amongst the most commonly performed surgeries.11 It is often necessary to manage patients with higher degree haemorrhoids when they cause trouble and recurring symptoms despite optimal medical management.12,13 The present study focused on the outcomes of two different approaches of performing haemorrhoidectomy, i.e., open and LigaSure® to determine which amongst these provides more favourable outcomes for managing patients with higher-grade symptomatic disease.
In the present study, patients who were selected for surgical correction of their hemorrhoidal disease had a median age of 32 years. Similar to this trend, a study was conducted by Hong et al.14 in which they found that the majority of the sufferers of hemorrhoidal disease belong to the age group of 30-39 years. One of the possible reasons for this disease becoming more common in young people is the trend of spending longer hours in toilets due to using mobile phones inside the lavatory.
The majority of haemorrhoid sufferers were females, constituting 55% of the total study population, showing a female-predominant trend of this condition. Hong et al.14 also reported a slight female predominance in terms of the burden of this morbidity. Similarly, in another study by Fisere et al., a clear-cut and statistically significant female dominance was observed (p = 0.0094).15 One of the possible reasons for this is the ability of women to get pregnant and go through this period of persistently raised intra-abdominal pressure due to a growing gravid uterus, which makes them more prone to develop this condition.16 Contrary to this, a study conducted by Kibret et al.17 found males to be affected more as compared to females. Another important finding of the present study was higher BMI and the proportion of haemorrhoid patients with obesity. This finding correlates with the fact that obesity increases the risk of having this morbidity, secondary to persistent exposure of hemorrhoidal vessels to the raised levels of pressure, thereby contributing to the development of the disease in this important anatomical structure.18,19
Upon analysis of the outcomes of these two approaches of performing haemorrhoidectomy, it was observed that the surgical length (p = 0.004) and blood loss during the surgery (p <0.001) were significantly reduced by the utilisation of LigaSure®, but it had no additional benefit over conventional approach (p = 0.440). Compared to this, Rehman et al. conducted a study with similar objectives and findings similar to the present study that intraoperative parameters such as surgery length and volume of lost blood were significantly reduced by LigaSure® (p <0.001).20 However, the difference occurred upon the analysis of postoperative pain assessment, where Rehman et al.20 reported significantly less pain in association with LigaSure® (p <0.001), which was not the case in the present study.
Similarly, in another study which was conducted by Al-Hamdany et al. to compare the outcomes of these two approaches of haemorrhoidectomy, it was found that LigaSure® not only lowered the volume of lost blood during surgery (p <0.001) but also reduced the length of surgery (p <0.001) as well as pain scores after surgery (p = 0.001).21 In studies by Hassan et al.22 and Surahio et al.23 similar trends of significantly improved results for all three aforementioned outcomes were reported with LigaSure® (p <0.05).
The reason behind this is unclear but can be attributed to the bias of the observer who quantified pain and the differences in the institutional protocols and practices regarding postoperative analgesia administration. Another possibility for the difference between the aforementioned studies and the present study, based on pain scores, can be attributed to differences in the time at which pain assessment was performed. Nonetheless, this finding of the non-significant impact of either procedure on the postoperative pain score and severity provides a unique insight compared to previous studies, all of which have demonstrated a significant and beneficial influence of Liga-Sure® on this particular outcome parameter.
Based on the results of the present study, it is evident that despite improved intraoperative outcomes with LigaSure®, both procedures are equally safe and can be used in the clinical setting, depending upon the availability of the equipment. However, in case of equipment availability, preferential use of the LigaSure® approach is recommended. For the ease of data collection and ethical issues raised by the institutional ethical committee, patients with comorbid conditions, especially diabetes and ischaemic heart disease requiring the use of antiplatelet therapy, were not made part of the study, which was the only limitation of the present study.
CONCLUSION
In conclusion, LigaSure® haemorrhoidectomy provides much better outcomes in higher grade haemorrhoids intraoperatively, but provides no substantial benefit in terms of procedure-related pain compared to the open operative procedure.
ETHICAL APPROVAL:
The study was conducted after obtaining the approval from the Hospital’s Ethical Committee of Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan (Ref. No: 0011/198/ MED/DGKMC).
PATIENTS’ CONSENT:
Informed consent was taken from all participants after explaining the study protocol and addressing the queries in detail.
COMPETING INTEREST:
The authors declared no conflict of interest.
AUTHORS’ CONTRIBUTION:
FA: Sample collection, analysis, writing, editing, and statistical analysis.
MRA: Supervision, statistical analysis, and corrections.
MAN: Supervision, writing, editing, and corrections.
All authors approved the final version of the manuscript to be published.
REFERENCES