Comparisons of the Efficacy of Ligasure Hemorrhoidectomy in Grade 3 and 4 Hemorrhoid Diseases

Abstract

Objective In recent years, Ligasure hemorrhoidectomy has been preferred in the treatment of grade 3 and 4 hemorrhoids rather than traditional surgery. This study aimed to compare the efficacy of Ligasure hemorrhoidectomy in grade 3 and 4 hemorrhoid treatment.

Methods A retrospective examination was made of the files of patients who underwent Ligasure hemorrhoidectomy because of grade 3 or 4 hemorrhoids. The demographic and clinical data of the patients were recorded. To evaluate pain severity after the procedure, a Visual Analog Scale (VAS) was used, and patient satisfaction at 6 months after the procedure was evaluated with a Likert-type scale. Early and late complications were determined in these follow-up examinations.

Results The patients included in the study had a mean age of 45 ± 11 years and 82 (75.9%) were male. The mean follow-up period was 18 months (range, 6–44 months). The mean age of patients with grade 4 hemorrhoid was significantly higher than that of those with grade 3 hemorrhoid (p = 0.006). Postoperative early and late (relapse) complications were seen at a higher rate in grade 4 patients compared with grade 3, but the difference was not statistically significant. More successful treatment outcomes were observed in grade 3 patients than in those with grade 4 hemorrhoid, but not to a statistically significant level.

Conclusion Ligasure hemorrhoidectomy is safer in terms of postoperative complications and treatment success is greater in patients with grade 3 hemorrhoids compared with those with grade 4 hemorrhoids.

Keywords

ligasure hemorrhoidectomy - grade 3–4 hemorrhoid - complication

Introduction

Hemorrhoids are vascular structures located in the submucosal region of the distal section of the anus and rectum, which aid anal continence. By expanding when pathological, hemorrhoids cause hemorrhoidal disease, which is the most frequently seen perianal disease. Patients with hemorrhoidal disease may present at polyclinics with symptoms such as bleeding, pain, sagging, itching, and soiling. Hemorrhoidal disease is seen most often between the ages of 45–65 years.[1] [2] [3]

Hemorrhoidal disease is categorized into two forms internal or external. Internal hemorrhoids are classified into 4 grades as follows[4].

• Grade I: The presence of evident hemorrhoidal vascularization, no prolapse,

• Grade II: Prolapse present with the Valsalva maneuver; prolapse reduces spontaneously,

• Grade III: Prolapse present with the Valsalva maneuver; prolapse can be reduced manually,

• Grade IV: Chronic prolapse is present and cannot be reduced manually.

• Grade 3 and 4 hemorrhoids are known as advanced-grade hemorrhoids. Traditional treatment methods (Milligan-Morgan/Ferguson) are the methods applied most frequently to advanced-grade hemorrhoids. However, there has been a recent increase in the application of treatment with the Ligasure device, which can cut and seal advanced-grade hemorrhoids. Ligasure is a bipolar electro-thermal device, which closes blood vessels with specific pressure and radio frequency regulation.[5] [6]

As the grade of hemorrhoidal disease increases, the treatment procedure shifts more to surgical methods. There are studies in literature that have evaluated the results of Ligasure hemorrhoidectomy in grade 3–4 hemorrhoids.[7] However, there is no study that has compared the efficacy of Ligasure hemorrhoidectomy in the treatment of grade 3 and 4 hemorrhoids. Therefore, this study aimed to compare and evaluate the efficacy of Ligasure hemorrhoidectomy in the treatment of grade 3 and 4 hemorrhoids.

Methods

This retrospective study included a total of 108 patients with a diagnosis of grade 3 or 4 hemorrhoid disease who underwent Ligasure (Aesculap Caiman, 17 cm, small jaw open sealer/divider) hemorrhoidectomy in the General Surgery Clinic of Bursa Yüksek İhtisas Training and Research Hospital. The patients were separated into two groups, grade 3 and 4 hemorrhoids. All the patients underwent Milligan-Morgan hemorrhoidectomy with Ligasure. In all cases, the treatment was performed by a single surgeon experienced in colorectal surgery. The demographic and clinical data and postoperative complications of the patients were recorded from the patient records.

Pain severity scores of all the patients were recorded at 6 hours postoperatively using a Visual Analog Scale (VAS). The VAS was marked from 0 to 10, with 0 representing no pain and 10 the most severe, intolerable pain.[8] At 6 months postoperatively, patient satisfaction with the treatment was evaluated at polyclinic follow-up examinations or by telephone, using a 5-point Likert measurement system of very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied.[9] All the patients underwent a detailed physical examination. The hemorrhoid grade was determined from an anorectal examination performed using anoscopy and flexible rectosigmoidoscopy/colonoscopy. Complications developing within the first month postoperatively were classified as early and after 1 month as late complications.

The patients included in the study were aged 18–70 years, with grade 3 or 4 hemorrhoid disease, and had not previously undergone any hemorrhoid surgical treatment. The study exclusion criteria were defined as the presence of strangulated or thrombosed grade 3 or 4 hemorrhoids, grade 1–2 or external hemorrhoids, co-existing perianal disease or inflammatory bowel disease, a history of perianal surgery, or the presence of hematological disease.

Lavage (250 mL) was applied twice to all patients, in the evening before the procedure and the early hours of the day of the procedure. 30 minutes before the procedure, routine antibiotic prophylaxis (cefazolin 1 × 1, 1 gr intravenous) was administered. The anoscope was placed with the patient in the lithotomy position. The Ligasure hemorrhoidectomy was started by preserving sufficient anal edge skin to avoid postoperative stenosis. Then by advancing from the submucosal space below the dentate line, both external and internal hemorrhoid components were excised as far as the anorectal junction. Bleeding control was performed with electrocautery when necessary. An anal spongostan was routinely placed in the anal canal of each patient.

Postoperative pain relief (paracetamol 500mg, 3 × 1 oral) was administered to all the patients. The use of a laxative syrup (667 gr lactulose dissolved in 1000 ml water, 2 × 1 oral) was recommended for 7 days after hospital discharge. Routine polyclinic follow-up examinations were performed by a specialist surgeon at 1 week, then at 1, 3, and 6 months postoperatively. Patients with unresolved rectal complaints (bleeding, discharge, pain, etc) underwent flexible rectosigmoidoscopy in these follow-up examinations. Disease relapse was determined with anorectal examination and flexible rectosigmoidoscopy.

Ethical Approval

Approval for the study was granted by the Ethics Committee of Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital (decision no: 2024-TBEK 2024/05–04, dated: 02.05.2024). All the study procedures followed the Helsinki Declaration.

Statistical Analysis

Data obtained in the study were analyzed statistically using SPSS vn. 21.0 software (Statistical Package for Social Sciences; SPSS Inc., Chicago, IL, USA). The conformity of the data to normal distribution was assessed with the Kolmogorov-Smirnov test. Measurable data meeting parametric conditions were stated as mean ± standard deviation values, and as median (minimum-maximum) values if distribution was not parametric. Categorical variables were reported as number (n) and percentage (%). In the comparisons of data between the two groups, the Independent Samples t-test was applied to parametric data and the Mann-Whitney U-test to non-parametric data. The Chi-square test was used in the comparisons of categorical variables. A value of p < 0.05 was accepted as statistically significant in all the statistical evaluations.

Results

The evaluation was made of 108 patients, comprising 82 (75.9%) males and 26 (24.1%) females with a mean age of 45 ± 11 (range:22–68) years and a mean follow-up period of 18 months (range, 6–44 months). The complaints on presentation at the clinic were determined to be hemorrhage in 38% of the patients, pain in 43.5%, constipation in 13.9%, and itching in 4.6%. There was determined to be comorbid disease in 13% of the patients; hypertension in 6.5%, diabetes mellitus in 5.6%, and other comorbidities in 0.9%. Of the total 108 patients, 105 were discharged on postoperative day one, and 3 were discharged 2 days later because of severe postoperative pain. Smokers comprised 38.9% of the patients, and grade 3 hemorrhoid disease was determined in 83.3%. Early postoperative complications were seen in 16 (14.8%) of the patients, such as bleeding in 4 (3.7%), discharge in 2 (1.9%), and edema in 10 (9.2%). Spinal anesthesia was applied to 104 patients and general anesthesia to 4. Full recovery was determined in 95.4% of the treated patients. According to the Likert patient satisfaction scale applied at 6 months postoperatively, 95.4% of the patients were satisfied and very satisfied with the treatment ([Table 1]).

Table 1 Distribution of demographic and clinical characteristics of the patients (n = 108)

Variables	Value
Age, years*	45 (± 11) (range: 22–68)
F/M, n (%)	26 (24.1)/82 (75.9)
Smoking, n (%)	42 (38.9)
Treatment method (Ligasure), n(%)	108 (100)
Hemorrhoid disease classification, n (%)
Grade 3	90 (83.3)
Grade 4	18 (16.7)
Operation duration, minute*	32 (± 7)
Preoperative Hgb*	12.5 (±1.4)
Postoperative Hgb*	12.1 (±1.5)
BMI (kg/m2)*	25 (±1.9)
Number of excised pedicle **,n (%)	2 (2–3)
Co-morbidity, n (%)	14 (13)
Diabetes mellitus	6 (5.6)
Hypertension	7 (6.5)
Others	1 (0.9)
Symptoms, n (%)
Hemorrhage	41 (38)
Pain	47 (43.5)
Constipation	15 (13.9)
Itchiness	5 (4.6)
VAS**, 6th	4 (3–5)
Likert satisfaction scale, n (%)
Very satisfied	51 (47.2)
Satisfied	52 (48.2)
Neutral	0 (0)
Unsatisfied	5 (4.6)
Very unsatifsfied	0 (0)
Postoperative complication, n (%)
Early	16 (14.8)
Late (relapse)	5 (4.6)
Treatment success	103 (95.4)

^* Mean (± standard deviation).

^** Median (25^th -75^th percentile), F: Female, M: Male, VAS: Visual analog scale, Hbg: Hemoglobin, BMI: Body mass index

The mean age of patients with grade 4 hemorrhoids was found to be significantly higher than that of those with grade 3 hemorrhoids (p = 0.006). No significant difference was determined between the two grade groups concerning smoking, gender, body mass index, operating time, mean VAS value at 6 hours postoperatively, mean number of excised hemorrhoid pedicles, patient satisfaction at 6 months postoperatively, and mean preoperative and postoperative hemoglobin values. Postoperative early and late (relapse) complications were seen at a higher rate in grade 4 patients compared with grade 3, but the difference was not statistically significant. During the mean 18-month follow-up period, with a minimum of at least 6 months, more successful treatment outcomes were observed in grade 3 patients than in those with grade 4 hemorrhoids, but not to a statistically significant level ([Table 2]).

Table 2 Comparison of data between the groups

Variables	Grade 3 Hemorrhoid	Grade 4 Hemorrhoid	p value
	(n:90)	(n: 18)
Age, years*	44 (± 11)	51 (± 10)	0.006
F/M, n (%)	23(25.6)/67(74.4)	3(16.7)/15(83.3)	0.42
Smoking, n (%)	36(40)	6(33.3)	0.59
BMI (kg/m2)*	25 (± 1.9)	25 (± 1.9)	0.86
Operation duration, minute*	32 (± 7)	32 (± 6)	0.69
Preoperative Hgb*	12.5 (± 1.3)	12.6(±1.6)	0.72
Postoperative Hgb*	12.1 (± 1.4)	12.2 (± 1.7)	0.76
VAS**, 6 th	4 (3–5)	4 (3–5)	0.79
Number of excised pedicle **,n (%)	2 (2–3)	2.5 (2–3)	0.60
Symptoms, n (%)
Hemorrhage	33 (36.7)	8 (44.4)	0.47
Pain	38 (42.2)	9 (50)
Constipation	14 (15.6)	1 (5.6)
Itchiness	5 (5.6)	0 (0)
Likert satisfaction scale, n (%)
Very satisfied	43 (47.8)	8 (44.4)	0.35
Satisfied	44 (48.9)	8 (44.4)
Unsatisfied	3 (3.3)	2 (11.1)
Postoperative complication, n (%)
Early	11 (12.1)	5 (27.8)	0.15
Late (Relaps)	3 (3.3)	2 (11.1)	0.15
Co-morbidity, n (%)	12 (13.2)	2 (11.1)	0.54
Diabetes mellitus	6 (6.7)	0 (0)
Hypertension	5 (5.6)	2 (11.1)
Others	1 (1.1)	0 (0)
Treatment success	87 (96.7)	16 (88.9)	0.15

^* Mean (± standard deviation)

^** Median (25^th -75^th percentile), F: Female, M: Male, VAS: Visual analog scale, Hbg: Hemoglobin, BMI: Body mass index

Discussion

Grade 3 and 4 hemorrhoids are advanced-stage hemorrhoid diseases, which are candidates for surgical treatment. This surgical procedure can now be performed with various methods and devices recently developed. Ligasure hemorrhoidectomy is one of these and is used rather than the traditional surgical method to minimize the severity of postoperative pain and complications.[10] Previous studies in the literature have evaluated the results of hemorrhoidectomy performed with Ligasure for grade 3 and 4 hemorrhoid disease.[7] [11] [12] However, there is no study in the literature that has compared the efficacy of Ligasure in the treatment of grade 3 and 4 hemorrhoid disease. Therefore, this study is of value as the first such study in literature.

The results of traditional Ferguson hemorrhoidectomy have been compared with Ligasure in previous studies. Compared with Ferguson hemorrhoidectomy, the operating time of Ligasure is shorter, the postoperative length of stay in hospital is shorter, and the degree of pain and the amount of blood loss are lower. These differences were determined to be statistically significant.[13] In another study comparing the traditional Milligan-Morgan hemorrhoidectomy with Ligasure hemorrhoidectomy, the Ligasure method was determined to result in statistically significant shorter operating time, less severe postoperative pain, a shorter length of stay in the hospital, less postoperative blood loss and an earlier return to daily activities.[14] Consequently, Ligasure hemorrhoidectomy has been proven to be a better and more reliable surgical treatment than traditional hemorrhoidectomy in respect of operating time, postoperative pain, and blood loss.[15] [16]

In studies in literature of patients who have undergone Ligasure hemorrhoidectomy for grade 3–4 hemorrhoid disease, the mean age has been determined to be in the range of 30–45 years, mean operating time of 8–36.6 minutes, postoperative mean VAS value of 3–4.1, mean relapse rate of 3.-7.8%, mean length of stay in hospital of 1–1.5 days, and grade 3 hemorrhoid rate of 49.6–72%.[17] [18] [19] [20] In the current study, the mean patient age was 45 years and the mean operating time was 32 minutes, consistent with the literature. Grade 3 hemorrhoid disease was present in 83.3% of the patients. The mean VAS value, mean length of stay in the hospital, and relapse rates were also consistent with the literature. In a previous study, there was seen to be postoperative minimal bleeding in 1 patient (0.4%) and anal stenosis in 1 patient (0.4%).[17] At 1 year postoperatively in another study, treatment was applied to 1 patient for anal stenosis, to 1 patient for anal fistula, and to 3 patients for anal fissure.[10] The incidence of postoperative bleeding after Ligasure hemorrhoidectomy has been reported to be between 0% and 10%.[16] [21] However, in the current study, no anal stenosis, anal fissure, or anal fistula complications were observed in any patient. Postoperative bleeding was seen in 3.7% of the patients and this rate was consistent with the literature.

In a meta-analysis by Bianca et al., the results of the treatment approaches to grade 3 and 4 hemorrhoids were compared. A total of 14 surgical techniques were identified in the treatment of grade 3 and 4 hemorrhoids: open (Milligan-Morgan) hemorrhoidectomy, closed (Ferguson) hemorrhoidectomy, transanal hemorrhoidal dearterialization (THD), harmonic scalpel, Ligasure hemorrhoidectomy, Starion, suture ligation, semi-closed, bipolar diathermy, partial stapled, stapled, Doppler-guided hemorrhoidal artery ligation, infrared photocoagulation, and laser. According to the results of that study, Ligasure hemorrhoidectomy was the best treatment method in respect of postoperative complications and relapse.[2]

In the current study, there was seen to be a significant difference in the mean age of the patients with grade 4 hemorrhoids compared with those with grade 3. The distribution of postoperative early and late complications was seen to be proportionally greater in the grade 4 patients than in the grade 3 patient group, but the difference was not statistically significant. The treatment success and patient satisfaction were found to be proportionally greater in the grade 3 patients than in the group with grade 4 hemorrhoids, but not at a statistically significant level.

Limitations

The limitations of this study were the single-cente design, the retrospective, and the limited number of patients.

Conclusion

Ligasure hemorrhoidectomy was determined to be more reliable concerning postoperative complications and treatment success in grade 3 hemorrhoid patients compared with grade 4 hemorrhoid patients. It was also seen that as the grade of hemorrhoid disease increased the mean age also increased. Nevertheless, there is a need for further prospective studies to be conducted with broader patient groups to be able to clarify the advantages and disadvantages of Ligasure hemorrhoidectomy in the treatment of grade 3 and 4 hemorrhoids.

Conflict of Interest

None declared.

Acknowledgments

This study has not been presented at any scientific meeting. The authors have no conflict of interest to disclose. There is no specific funding that has been received to report this submission.

Author's Contribution

Ali Kemal Taşkın and Enes Kandemir made the study design, data collection, data analysis, and writing. In addition, Ali Kemal Taşkın did a literature review and writing.

Place of work: This study was conducted at 'University of Health Science, Bursa Yuksek Specialization Training and Research Hospital, Department of General Surgery, Bursa, Turkey'

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Publikationsverlauf

Eingereicht: 27. Juni 2024

Angenommen: 24. Oktober 2024

Artikel online veröffentlicht:
18. Dezember 2024