Comparison between stapled hemorrhoidopexy and harmonic scalpel hemorrhoidectomy in the management of third- and fourth-degree piles: a randomized clinical trial

The estimated worldwide prevalence of hemorrhoidal disease in adults is reported to be 11% [1]. In Egypt, hemorrhoid disease is a frequent reason for patients to seek medical attention. The incidence of hemorrhoids in patients undergoing colonoscopy was estimated to be 18% in Egypt [2]. There is currently a debate on how to classify hemorrhoidal disease, with many arguments in favor of Goligher’s classification. This is a descriptive classification of the characteristics of internal piles and distinguishes different groups based on the degree of prolapse. It provides a subjective representation of severity; however, it does not accurately portray the severity of symptoms [3]. There is currently no consensus on the use of the Goligher classification for hemorrhoids; however, in this study we aimed to grade the piles according to Goligher’s classification (see Table 1; [4]).

In the case of symptomatic grade III or grade IV hemorrhoids, surgical treatment is necessary. Additionally, surgery may be necessary in the case of failure of medical treatment or in the presence of associated conditions such as anal fissure or fistula. Different techniques are employed to treat hemorrhoidal disease, including conventional techniques such as Ferguson’s closed hemorrhoidectomy and Milligan–Morgan’s open hemorrhoidectomy. Additionally, a variety of devices and methods are employed to facilitate the procedure and reduce patient discomfort during the postoperative period. Stapled hemorrhoidopexy (SH) was first introduced by Longo in 1998 to be used in prolapsed hemorrhoidal disease. The goal of SH is not only to obliterate submucosal vessels, but also to return prolapsed rectal mucosa to its pre-prolapse state and to correct the anatomical relationship between the anorectal mucosa and the underlying muscle [5]. The harmonic scalpel was first introduced in 1992, and the goal of harmonic scalpel hemorrhoidectomy (HSH) is to use ultrasound as a source of energy, with minimal thermal damage to the surrounding tissue [6].

There were 70 patients in our study, with 35 patients in each group: 50 (68.7%) males and 20 (31.25%) females (p = 0.315). Group I underwent SH and group II underwent HSH. The mean age of group I was 42.94 years (SD: ± 11.8) and in group II it was 42.20 years (SD: ± 7.34; p = 0.315). Regarding the duration of the procedures, the mean time in the SH group was 24.42 min ± 2.367 while in the HSH group it was 31.48 min ± 2.21 (p = 0.186; Table 2). Table 2 shows the patients’ characteristics and the mean operative time between the two groups.

Postoperative pain was assessed in two stages: during the first 2 weeks and after the first 2 weeks on the basis of the Visual Analogue Scale (VAS), with scores ranging from 0 to 10, with 0 being the lowest and 10 the maximum. During the first 2 weeks: In group I, 18 (45%) patients scored their pain as mild from 1 to 3, 20 (50%) patients scored their pain as moderate from 4 to 6, and two (5%) patients scored their pain as severe from 7 to 9. In group II, 14 (35%) patients scored their pain as mild from 1 to 3, 22 (55%) patients scored their pain as moderate from 4 to 6, and four (10%) patients scored their pain as severe from 7 to 9 (p = 0.275; Table 3).

Although, postoperative pain in patients who underwent SH was lower during the first 2 weeks, there was persistent mild postoperative pain in most of these patients. However, in those who underwent HSH, there was significant improvement in pain after 2 weeks and, therefore, patient satisfaction was significantly higher in the HSH group (Table 4). Table 4 shows the postoperative pain scores between the two groups.

Wound infection was detected in three (5%) patients in group I and no patient in group II (p = 0.077). Postoperative bleeding occurred in four patients in group I in the form of spotting after defecation, but it was only experienced during the first postoperative month, while no patient in group II was affected by this (p = 0.039). There were no cases of incontinence in group II. In group I, there were three (15%) cases of flatus incontinence only, according to the Wexner score of 3/20 (p = 0.026), but after taking a detailed history these were found to be cases of urgency to defecate rather than incontinence. There were seven cases (20%) of recurrence at the 1‑year follow-up in group I and one case (2.9%) in group II (p = 0.024). These results are presented in Tables 5, 6 and 7.

Postoperative patient satisfaction was assessed after 2 weeks using a 5-point Likert scale: 1=very dissatisfied, 2=dissatisfied, 3=unsure, 4=satisfied, and 5=very satisfied. In group I there were two (5.7%) patients who were very dissatisfied, whereas in group II there were no cases of very dissatisfied patients (p = 0.15). In group I, five (14.3%) patients were dissatisfied and in group II there was one (2.9%) dissatisfied patient (p = 0.198). In group I, four (11.4%) patients were unsure, while in group II there were three (8.6%) patients who were unsure (p = 0.69). In group I, 15 (42.9%) patients were satisfied and in group II this number was 13 (37.1%; p = 0.8). Finally, in group I, nine (25.7%) patients were very satisfied, while in group I there were 18 (51.4%) very satisfied patients (p = 0.049; Table 8 and Fig. 8).

Patient satisfaction is a major factor in the surgeon’s decision-making process and is the primary reason why piles surgery is not a preferred procedure for the majority of surgeons. However, it has been observed that the success of any procedure is not the only factor that influences postoperative patient satisfaction: Patient satisfaction can be affected by many factors such as patient perception. Recent studies have indicated that adequate postoperative pain management can lead to increased patient satisfaction [7]. However, there is still a need for more information on patient satisfaction specifically in regard to the various types of piles surgery. This study attempted to compare the effectiveness of SH versus HSH.

The comparison between the two methods revealed no significant difference in the mean duration of the procedure: 24.42 min ± 2.367 in the SH group and 31.48 min ± 2.21 in the HSH group (p = 0.186). The fact that SH can be performed by an experienced coloproctology surgeon may be why the duration of SH was shorter. However, it does not negate the fact that SH requires a skilled hand due to the technical nature of the procedure. In our study HSH was found to be slower, which may be attributed to the fact that it works on each pile individually, thus varying in time depending on the number of piles. Pain was assessed at two stages by asking patients about the pain in the initial 2 weeks and at 3 months post-surgery. Stapled hemorrhoidopexy is well known as one of the least painful methods in pile surgery [8]. Chung et al. [6] compared the two techniques in their study of 88 patients, and found that the SH group reported significantly lower VAS postoperative pain, reduced hospitalization, quicker return to normal activities, and increased patient satisfaction. Contrary to other studies, such as the study by Bilgin et al. [9], mean total pain scores did not achieve statistical significance. In our study, there was a significant difference in pain during the initial 2 weeks. However, the most notable finding was the dramatic improvement in pain after 2 weeks in the HSH group, with persistent mild pain reported during the 3 months postoperatively in the SH group.

Postoperative complications were significantly increased in the SH group, with bleeding being one of the most significant short-term complications. Previous comparative studies between the two techniques were inconclusive, with Chung et al. [6] reporting a lower incidence of postoperative bleeding for SH, which is in contrast to the majority of studies in the literature. Bilgin et al. [9] reported less postoperative bleeding with the HSH technique, while other studies, such as that by Armstrong et al. [10], found no short-term postoperative bleeding. In the literature, the postoperative bleeding rate for SH ranges from 4% to 26% [11‐13], while for HSH it ranges from 0% to 4% [9, 10, 14]. In our study, postoperative bleeding was present in four patients in the SH group in the form of spotting with defection; in two patients it persisted for 3 months.

In this study, there were no reported cases of wound infection in the HSH group while three cases of wound infection were found in the SH group: two of infected perianal hematoma during the first month and one case of intersphincteric collection 2 months after surgery. In the literature, infection is generally agreed to be a rare complication in HSH [9, 15], while in SH various types of wound infection have been described. The first case of death due to wound infection was reported by Bohnner et al. [16], and since then, numerous studies [17‐22] have reported other septic complications due to SH. It is not possible to draw a definitive conclusion on the prevalence of wound infections in SH; however, it is generally accepted that these complications can be life-threatening.

There were no cases of incontinence in the HSH group because during the procedure the metal plate of the harmonic scalpel enables good dissection and identification of the internal sphincter, thereby avoiding its injury, which is a great advantage of this technique. In a recent meta-analysis [23] that compared nine types of piles surgery, HSH was found to have the lowest incontinence rate. However, in the SH group in our study there were three cases of flatus incontinence (Wexner score of 1–3/20), which is a significant difference between the two techniques. There is high variability regarding the rate of incontinence in SH in the literature. This variability, in our opinion, is related to the complexity of the technique; Bilgin et al. [9] reported a 2% rate of flatus incontinence with SH. Michalik et al. [24] conducted a study to assess long-term outcomes after SH. In their study, 21% patients and 11% patients presented with flatus incontinence and fecal incontinence, respectively, which is considered a very high rate and may reflect a type of bias.

In the literature there is consensus in favor of HSH when comparing recurrence rates between the two procedures. In a meta-analysis conducted by Aibuedefe et al. [8], HSH was found to have one of the lowest recurrence rates when compared to 12 other techniques. Additionally, Talha et al. [25] claimed no recurrence rate in the HSH group. On the other hand, a number of studies discussed recurrence rates of SH, with some authors reporting recurrence rates as high as 60%, for example, Zacharakis et al. [26], and others reporting more reasonable rates, such as Jayaraman et al. [27], who found 23 recurrences in a group of 269 patients undergoing SH. At the end of a 2-year follow-up, Bilgin et al. [9] reported recurrence in seven patients undergoing SH (13.7%) with only one case of recurrence in their HSH group (2.1%). In our study, we found two cases of recurrence among the HSH patients and seven cases of recurrence among 35 patients (8.6%) in the SH group.

Patient satisfaction was considered to be one of the most significant differences between the two techniques in our study. As this point has not been extensively discussed previously, it is important to note that patient satisfaction is dependent on the surgeon’s preference for a technique and his experience using it. In our study, patient satisfaction was observed to be higher in the HSH group. According to Chen et al. [28], the number of patients who were poorly satisfied or dissatisfied was 121 of 321 patients undergoing SH. In the study by Chung et al. [29], comparing the outcome of patients undergoing hemorrhoidectomy with harmonic scalpel, with bipolar scissors, or with the Milligan–Morgan technique, the authors concluded that HSH had the highest satisfaction score of the three methods.

It is important to note that there is no one-size-fits-all approach to the management of grade III and grade IV piles. Each technique has its own advantages and disadvantages, and each patient is presented with a unique situation: They must choose between SH, with less postoperative pain and a greater likelihood of recurrence and increased complications, or HSH, with lower recurrence rates and increased safety but with higher postoperative pain in the first 2 weeks after surgery. In our study, HSH was determined to be safer, easier, and associated with a lower incidence of recurrence at the 1‑year follow-up compared with the SH technique. In addition, there is better patient satisfaction, which is one of the greatest challenges in the management of hemorrhoids. This work recommends HSH as a cornerstone procedure along with the various other classic operations due to its ease of use and feasibility.