Abstract
Introduction
The estimated prevalence of hemorrhoidal disease (HD) worldwide ranges from 2.9% to 27.9%. Conservative, medical, non-operative, and surgical therapy approaches are applied in HD treatment. Milligan-Morgan (MM) hemorrhoidectomy which is the most well-known and frequently applied surgical treatment method, and Laser hemorrhoidoplasty (LH) are among the accepted treatment methods in Grade 2-3 HD treatment where medical treatment is insufficient.
Purpose
In this study, the early results of laser hemorrhoidoplasty and Milligan-Morgan hemorrhoidectomy techniques were compared.
Material and Methods
A randomized clinical trial. The study included ASA 1-3, total 85 patients aged 18-70 years old with symptomatic Grade 2 and Grade 3 hemorrhoidal disease whose symptoms persisted despite at least one month of medical treatment. Fifty-four patients were allocated to Group L, whereas 31 were allocated to Group M. Age, gender, weight, body mass index, preoperative symptoms, presence of additional disease, use of anticoagulant medication, and length of hospital stay of the patients included in the study were recorded. Rescue analgesic used was recorded. Postoperative VAS score and complications were recorded within 10 days. The total energy numbers applied to all packages were recorded.
Results
The incidence of minor perioperative hemorrhage was significantly lower in Group L compared to Group M (P = .035). The postoperative 3rd-hour VAS scores were statistically significantly lower in Group L compared to Group (P < .001). At the 3rd hour postoperatively, the need for rescue analgesia was statistically significantly higher in Group M compared to Group L. On the seventh postoperative day, Group M needed considerably more rescue analgesia compared to Group L (P < .001, P = 1.00, P = .035, respectively). The cut-off value of 571 J was calculated in Group L.
Conclusion
We believe that it is not an advantageous method compared to MM hemorrhoidectomy, both in terms of patient comfort and cost-effectiveness, since postoperative pain, which is shown as the most important advantage of LH over conventional hemorrhoidectomy methods in the literature, can be relieved with simple NSA-I rescue analgesia in patients undergoing MM. Trial Registration: 03.06.2021/21-63.
Keywords
Introduction
The estimated prevalence of hemorrhoidal disease (HD) worldwide ranges from 2.9% to 27.9%. Approximately 1/3 of the patients receive medical counseling. 1 HD treatment is determined by the disease’s internal or external nature, the intensity of symptoms, and the internal hemorrhoidal disease (IHD) stage. 2 Conservative, medical, non-operative, and surgical therapy approaches are applied in HD treatment. 3 Milligan-Morgan (MM) hemorrhoidectomy which is the most well-known and frequently applied surgical treatment method and, Laser hemorrhoidoplasty (LH) are among the accepted treatment methods in Grade 2-3 HD treatment where medical treatment is insufficient. 4
The primary outcome of this study is to compare the pain levels of MM hemorrhoidectomy and LH method in the early postoperative period. The secondary outcomes are to compare the postoperative complications (hematoma, hemorrhage, incontinence development) other than pain in the early period, to reveal the effect of adding postoperative calcium dobesilate to the treatment on pain and other postoperative complications, and to determine the optimal energy levels in terms of postoperative pain and other complications in the LH group.
Methods
Randomization
Laser hemorrhoidoplasty was planned for the first 56 patients, and Milligan-Morgan hemorrhoidectomy for the next 56 patients. In Group L, it was planned to use postoperative calcium dobesilate in the first 28 patients and not to use postoperative calcium dobesilate in the next 28 patients. After the laser hemorrhoidoplasty group was completed, it was decided to terminate the Milligan-Morgan hemorrhoidectomy group with 34 patients, since it was anticipated that the planned number of patients would not be reached during the study period due to pandemic conditions. In this group, it was planned used postoperative calcium dobesilate in the first 17 patients and not used postoperative calcium dobesilate in the next 17 patients. At the end of the study, a total of 32 patients in the Milligan-Morgan hemorrhoidectomy group could be reached. Postoperative VAS scores and rescue analgesic use of the patients were evaluated by the investigator who did not know the treatment method applied to the patients. The mean of VAS in the laser hemorrhoidoplasty group was 1.3 ± .7, and the mean of VAS in the Milligan group was 4.4 ± 1.8 in the Post Hoc analysis result, which was 100%, and the number of patients included in the study was found to be sufficient. Post HPc power analysis was performed with Online Clincalc program. (https://clincalc.com/stats/Power.aspx).
The diagnosis and inclusion of the patients in the outpatient clinic, their information and consent were determined by simultaneous evaluation by 2 surgeons. Patients were randomized by a different investigator. Surgery and laser applications of all patients were performed by 2 different surgeons, the same primary and assistant surgeon. Postoperative follow-up of the patients was carried out by a different researcher who was unaware of the procedure.
This study was conducted as a prospective randomized controlled trial with the approval of the Health Sciences University Hamidiye Clinical Research Ethics Committee (approved date/number: 03.06.2021/21-63),at the General Surgery Clinic of Sultan 2. Abdulhamid Han Training and Research Hospital, between 22.09.2021 and 10.10.2022. A written agreement was acquired from all patients enrolled in the trial after they were informed about the surgical procedure and scientific investigation to be conducted.
The study included ASA 1-3 patients aged 18-70 years old with symptomatic Grade 2 and Grade 3 hemorrhoidal disease whose symptoms persisted despite at least one month of medical treatment. Patients under the age of 18 and over the age of 70, patients who had never received medical treatment, patients with Grade 1 and Grade 4 hemorrhoidal disease, patients with an ASA score of 4 or higher, pregnant patients, patients who had previously undergone anorectal surgery, and patients with the additional anorectal disease and patients whose scientific consent could not be obtained were not included in the study. In addition, individuals with extra anorectal illness discovered intraoperatively who did not comply with postoperative medical therapy and did not return for follow-up were excluded from the study.
Age, gender, weight, body mass index (BMI), preoperative symptoms (bleeding, itching, pain, swelling), presence of additional disease, use of anticoagulant medication, and length of hospital stay of the patients included in the study were recorded. The patients in the study were divided into 2 groups. Group L consists of patients who received laser hemorrhoidoplasty, while Group M consists of patients who underwent Milligan-Morgan hemorrhoidectomy. Patients in both groups were separated into 2 subgroups based on whether or not they received postoperative calcium dobesilate treatment. Laser hemorrhoidoplasty in the first group and hemorrhoidectomy in the second group, respectively. Postoperative calcium dobesilate was started randomly within the group.
All surgical procedures applied to the patients were performed under general anesthesia in operating room conditions. All patients received parenteral 500 mg metronidazole prophylaxis 30 minutes before induction of anesthesia. All patients were operated on in the lithotomy position and bupivacaine infiltration was applied to the perianal region at a dose of 1 mg/kg before the procedure. The anal region was explored with an anoscope, and the localization and grade of the hemorrhoidal cushions were recorded. A maximum of 4 hemorrhoidal cushions were processed in a patient in Group L, and a maximum of 3 hemorrhoidal cushions in Group M. Patients who were found to have an additional anorectal disease, Grade 4 hemorrhoidal cushions, and rectal prolapse during anal exploration were excluded from the study. Milligan-Morgan conventional hemorrhoidectomy method was applied to the patients in Group M. Patients in group L underwent laser hemorrhoidoplasty.
Laser Hemorrhoidoplasty Technique
A 1470 nm with a diameter of 1.8 mm diode laser device was used. After making a 1 mm opening from the anocutaneous line at the distal border of the hemorrhoidal pocket, the fiber was inserted into the hemorrhoidal tissue parallel to the rectal axis from the submucosal space up to the proximal part of the enlarged hemorrhoid. A total of 8 W 3-second pulses with 1-second pulse pauses were used to coagulate the hemorrhoidal pocket. Laser application was performed throughout the entire hemorrhoid pocket from proximal to distal. A maximum of 250 J energy was used for one pack. The total energy numbers applied to all packages were recorded. The applied power currents at the time of the collapse of each hemorrhoidal cushion were documented. 5
Milligan-Morgan Hemorrhoidectomy Technique
The standard Milligan-Morgan technique was applied. 6 The standard Milligan-Morgan technique was applied. Once the hemostatic suture was performed with 2/0 round vicryl from the proximal (pedicle) of the hemorrhoidal cushions, and after the submucosal 1/1000 adrenaline injection, it was excised from the anocutaneous line using cautery, and the hemorrhoidal cushion was excised using ligasure. Hemorrhoidectomy was performed on a maximum of 3 hemorrhoidal cushions for each patient.
The operation times of all patients, the number of hemorrhoidal cushions that underwent the procedure, and the total amount of energy applied to each hemorrhoidal cushion in Group L patients were recorded. Perioperative minimal bleeding was noted. In Group L patients, the duration of the operation, the number of hemorrhoidal cushions treated, and the total and total energy applied to each hemorrhoidal cushion were recorded. There was minimal bleeding during surgery. In the postoperative period, paracetamol was administered orally at a dose of 20 mg/kg as an analgesic. Patients’ 3rd-hour, 1st-day, and 7th-day VAS scores were recorded postoperatively. Patients were examined using a VAS score ranging from 0 to 10. 7 Patients’ hospital stay were documented. In the postoperative period, all patients were prescribed a high-fiber diet, 1500 mg/day of metronidazole, 20 mg/kg/day of oral paracetamol as analgesia, and for some patients, 1000 mg of calcium dobesilate each day. Rescue analgesic (RA) was administered to patients with a VAS score of 4 and above. Nonsteroidal anti-inflammatory (NSAI) drugs (tenoxicam, naproxen sodium, flurbiprofen) were used for RA. Postoperative complications (hematoma, hemorrhage, incontinence development) were recorded within 10 days. The Kirwan incontinence scale was used to evaluate incontinence. 8
Statistical Analysis
Descriptive statistics were used to describe continuous variables (mean, standard deviation, minimum, median, maximum). The Shapiro-Wilks test was used to analyze the conformity of continuous variables to the normal distribution. The Mann Whitney u test was used to evaluate the relationship between 2 continuous independent variables that did not follow a normal distribution. Using the Student’s t test, the relationship between 2 continuous independent variables with a normal distribution was evaluated. The Spearman-RhoRho Correlation coefficient was used to investigate the relationship between 2 continuous variables that did not adhere to a normal distribution. The relationship between categorical variables was examined using the Chi-Square test. The statistical significance level was determined as .05. Analyzes were performed using MedCalc® Statistical Software version 19.7.2 (MedCalc Software Ltd, Ostend, Belgium; https://www.medcalc.org; 2021). Sufficient sample size for comparison was made using g power 3.1.6.9. When VAS pain was measured as 3 ± 1.5 and 4 ± 1.1, .05 error .95 power change magnitude was calculated to be .78; statistically, a total of 74 patients were calculated for inclusion. 9
Results
This study included 85 patients between the ages of 22 and 70 with an ASA score of 1-3. Fifty-four patients were allocated to Group L, whereas 31 were allocated to Group M. CONSORT flow diagram are shown in Figure 1. Demographic data of the patients, operation time, and postoperative hospital stay are shown in Table 1. CONSORT flow diagram. Demographic Data of the Patients, Operation Time, and Postoperative Hospital Stay. aYates Continuity Correction. bStudent t-test. cMann Whitney Test. Sd: Standard sapma, Med: Median, min: minimum, max: maximum, BMI: Body mass index. Bold represents statistical significance.
In terms of gender and age, there was no statistically significant difference between the 2 groups (P = 1.000, P = .064, respectively). In Group L, 28 patients did not receive calcium dobesilate postoperatively, while 26 patients received it. 14 patients in Group M did not receive postoperative calcium dobesilate, compared to 17 who received it.
The Number of Surgically Treated Hemorrhoidal Cushions, Hemorrhoid Grades, and the Perioperative Minor Bleeding Results of the Patients are Shown in Table 2.
aMann Whitney u test.
bYates Continuity Correction.
Sd: Standard deviation, Med: Median, min: minimum, max: maximum. Bold represents statistical significance.
Postoperative VAS Scores of Patients.
aMann Whitney u test.
bFriedman test.
Sd: Standard deviation, Med: Median, min: minimum, max: maximum. Bold represents statistical significance.
Post-Hoc Pairwise Comparisons of Patients’ VAS Scores.
Bonferroni düzeltmeli Wilcoxon Signed Rank Test. Bold represents statistical significance.
Post-Operative Rescue Analgesic Requirements of Patients.
aYates Cont. Correction. Bold represents statistical significance.
In the comparison of postoperative complications of the patients, 12 (22.2%) patients in Group L and 2 (6.5%) patients in Group M encountered hemorrhage, but no patients experienced hematoma or incontinence. There was no statistically significant difference in postoperative complications between the 2 groups (P = .113). According to the administration of calcium dobesilate, there was no statistically significant difference in postoperative bleeding between Group L and Group M (P = .136, P = .488, respectively).
Intragroup VAS Scores According to Postoperative Calcium Dobesilate Use.
aMann Whitney u test.
Sd: Standard deviation, Med: Median, min: minimum, max: maximum. Bold represents statistical significance.
The Relationship Between Postoperative Hemorrhage and Mean Joule Levels of Patients in Group L.
Mann Whitney u test.
Sd: Standard deviation, Med: Median, min: minimum, max: maximum. Bold represents statistical significance.
Correlation Between Applied Energy Amounts and Postoperative VAS Scores in Group L.
Spearman’s rho test. Bold represents statistical significance.
ROC Analysis of Group L.
aThe maximum Kolmogorov-Smirnov (K-S) metric.
bIn the case of multiple cutoff values associated with Max K-S, the largest one is reported. Bold represents statistical significance.

ROC analysis of Group L.
Discussion
There are several limitations of this study. These are the small number of patients, the short postoperative follow-up period, and the wide patient age range.
Initial treatment of hemorrhoidal disease is a conservative approach. When conservative therapy procedures are insufficient, interventional treatment methods are used.10,11 Although numerous treatments are applied in the treatment, it is still debatable which is beneficial and painless. 12 Minimally invasive and invasive procedures are frequently needed for treating HD of high grades.13,14 Among the invasive methods, the most commonly applied surgical procedures today are Milligan Morgan and Ferguson excision-ligation methods.15,16 It has been noted, however, that these 2 surgical techniques are associated with extensive postoperative pain.12,16 Although Milligan-Morgan is still accepted as the gold standard interventional treatment method, serious postoperative pain, and complications associated with the excision of hemorrhoid tissue have been reported.11,17 In this study, the widely used interventional excisional hemorrhoidectomy technique, Milligan-Morgan, and the non-excisional interventional LH technique were compared.
Studies in the literature have reported that the duration of surgery was significantly shorter in the Laser group.18–21 In our study, Group L mean operative time was statistically significantly shorter than Group M, compatible with the other studies.
In the comparative studies in the literature, there is not enough data on the number of hemorrhoidal cushions treated in a single session. In our study, there was no statistically significant difference in hemorrhoid grade between the 2 groups. However, the number of treated hemorrhoidal cushions was statistically significantly higher in Group L than in Group M. Hence, LH application is considered to be superior in terms of processing more hemorrhoidal cushions in a single session.
According to literature search by Longchamp et al, 11 only bleeding problems were recorded intraoperatively among the 14 laser application procedures analyzed. In our study, we did not encounter any issues other than intraoperative bleeding. According to Jain et al, 22 there was no significant difference between the LH and MM groups for perioperative bleeding. Alsisy et al 18 reported that intraoperative bleeding was reported to be statistically significantly less in the Laser group. Sadra et al 20 reported that perioperative bleeding was reduced, which is consistent with our findings.
In terms of postoperative hemorrhage, Alsisy et a 18 reported no statistically significant difference between the Laser and Milligan-Morgan groups. Similar to the results of this study, there was no significant difference between the 2 groups in terms of postoperative bleeding issues in our study.
In our study, there was no statistically significant difference between patients who used calcium dobesilate in both groups and those who did not use it in terms of postoperative problems. These findings demonstrated that the phlebotonic agent calcium dobesilate did not contribute to the avoidance of early postoperative problems in patients who underwent both laser and Milligan-Morgan techniques. However, data on the long-term outcomes of our trial should be awaited to evaluate it in terms of potential problems and recurrence in the late period.
In the literature, no statistically significant difference was found between LH and MM groups in terms of hospital stay.18,23 In our study, although the average length of hospital stay was shorter in both groups compared to previous studies, Group L had a statistically significantly shorter hospital stay. The reason for the shorter operation times in our study compared to the studies in the literature is due to the fact that anesthesia induction and awakening times were not taken into account.
In studies comparing Millligan-Morgan (MM) hemorrhoidectomy with Laser Hemorrhoidoplasty (LH) procedures, it has been reported that patients who had LH experienced considerably less postoperative pain.18–21 In our study, although the postoperative 3rd-hour pain was much less in Group L than in the MM hemorrhoidectomy group, there was no significant difference in the first and 7-day pain levels in the Laser group compared to the MM hemorrhoidectomy group, unlike other studies in the literature. In contrast to Group L, Group M required considerably more rescue analgesics during the postoperative third hour and seventh day. Therefore, Group L was found to be more advantageous in terms of postoperative rescue analgesic use.
In comparisons including postoperative hemorrhage, different results are reported. In the study by Sadra et al, 20 they also found that the amount of postoperative bleeding was less in the Laser group, Alsisy et al 18 reported that there was no difference. In our study, no significant difference was found in terms of postoperative bleeding. In addition, our study, unlike other studies, found no significant difference in terms of bleeding in the early period between the 2 groups of patients receiving postoperative calcium dobesilate. This data indicates that the use of postoperative calcium dobesilate is not effective in preventing early postoperative bleeding.
Although studies in the literature generally report that Laser application is advantageous in terms of postoperative pain and bleeding compared to the conventional hemorrhoidectomy method, in line with our findings, Senagore et al 24 reported that Laser application was not advantageous in terms of postoperative pain and bleeding. According to the findings of our study, the MM hemorrhoidectomy approach is safe for the treatment of hemorrhoids revealing that it provides less postoperative pain and patient comfort with NSA-I rescue analgesia like laser application.
The literature lacks sufficient evidence of the efficacy of phlebotonic drugs following hemorrhoidectomy, and the results are controversial. 3 Colak et al 25 observed that the use of calcium dobesilate following conventional hemorrhoidectomy reduced pain on the first postoperative day but there was no statistical significance, and on the second, third, and seventh days decrease was statistically significant. According to La Torre et al, 26 the administration of calcium dobesilate during MM hemorrhoidectomy reduced postoperative pain and hemorrhage. According to Mlakar et al, 27 the administration of calcium dobesilate following stapled hemorrhoidopexy was not advantageous in terms of postoperative analgesic consumption and bleeding. In our study, it was discovered that the use of calcium dobesilate in the Laser group did not give any benefit in terms of postoperative pain, and it considerably increased postoperative pain on the first and seventh postoperative days in Group M.
No approved standard application protocol for the LH approach has been defined in the literature. Various surgeons employ a variety of entry points, hemorrhoidal cushion locations, and energy levels. 5 No data on the safe and effective total energy level of LH patients were discovered in the literature. In the study by Jain et al, 22 Poskus et al 5 reported the application of a maximum of 250 joules per hemorrhoidal cushion, Brusciano et al 28 reported that roughly 240-288 joules of energy were applied to a single hemorrhoidal cushion. According to Jain et al, 22 the overall energy level is 611.3 joules. Unfortunately, there are insufficient data in the scientific literature to establish a correlation between the amount of energy used and postoperative bleeding and pain in individuals who underwent laser hemorrhoidoplasty. The relationship between the amount of energy administered to patients in the Laser hemorrhoidoplasty group and postoperative hemorrhage and pain is one of the most remarkable findings of our study. In our study, it was found that as the total energy level increased, postoperative hemorrhage and pain increased significantly. According to the results of this study, the risk of postoperative bleeding may increase if the total energy level to be applied to a patient is greater than 571 joules.
Although the literature indicates that the recurrence rates after laser treatment are relatively low, no significant difference is noted when compared to conventional hemorrhoidectomy procedures.12,13,28,29 Since the early postoperative results were evaluated in our study and some patients did not have long-term results, data on recurrence could not be obtained yet.
In Conclusion
We believe that the LH technique is not advantageous in terms of postoperative bleeding compared to the MM hemorrhoidectomy method. It was observed that the need for rescue analgesics increased in the MM group, but the rescue analgesia administered with simple NSA-I yielded postoperative VAS scores similar to those in the LH group. In addition, we believe that the use of calcium dobesilate following both LH and MM hemorrhoidectomy has no advantage in terms of pain and hemorrhage, and even causes a rise in the amount of pain in patients who have undergone MM hemorrhoidectomy; therefore, we do not recommend its use. It was established that there was a strong association between the total energy level applied and postoperative pain and hemorrhage in patients undergoing LH, and the threshold value for bleeding was 571 joules. Therefore, we think that clinical studies are needed in this context for the standardization of safe energy levels in LH application. We believe that it is not an advantageous method compared to MM hemorrhoidectomy, both in terms of patient comfort and cost-effectiveness, since postoperative pain, which is shown as the most important advantage of LH over conventional hemorrhoidectomy methods in the literature, can be relieved with simple NSA-I rescue analgesia in patients undergoing MM.
Limitation of This Study
1. Low number of patients 2. Short post-operative follow-up 3. Wide age range of patients
Ethical Statement
Ehical Approval
Health Science University Hamidiye Clinical Research Ethics Committee (Approval date/no: 03.06.2021/ 21-63) Sultan 2. Abdulhamid Han Training and Research Hospital General Surgery Clinic.
Data Availability Statement
All data generated or analyzed during this study are included in this article.
Footnotes
Author Contributions
Adas Cemil: Study design, surgical examination, literature review, article writing. Kesici Ugur: Study design, all surgical examination, literature review, article writing. Genc Mahmut Salih: Surgical examination, literature review. Karadag Merve: Surgical examination, literature review. Mehmet Guray Duman: Literature review, English editing. Boluk Sümeyra Emine: Surgical examination, literature review.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
