Study selection

Out of a total of 6692 records, 3088 duplicates were removed. The remaining 3604 records were screened by title and abstract, resulting in the exclusion of 3338 records (92.6%). The full text of 20 reports could not be retrieved. The remaining 244 reports were assessed for eligibility, and 84 (34.4%) were excluded for not meeting the inclusion criteria, with the reasons listed in Fig. 1. An additional two reports meeting the inclusion criteria were identified through snowballing references from included studies. In total, 162 studies published between 1980 and 2023 met the inclusion criteria and were analyzed in this review.

Fig. 1Demographic and clinical characteristics

The 162 studies originated from 38 different countries (Table 1; Fig. 2). The six most represented countries were Italy (n = 18), China (n = 15), India (n = 14), the UK (n = 13), Egypt (n = 13), and Pakistan (n = 12). Nineteen (11.7%) studies were multicenter. The median recruitment duration was 20 months (IQR 12–28). The median cohort size was 84 patients (IQR 50–130). Gender distribution was reported in 153 (94.4%) of the studies. Of the total 18,667 patients, 10,346 (55.4%) were male. Most studies (95.1%) compared two different treatments, while eight studies (4.9%) compared three different treatments. The median follow-up time in the studies was 12 months (IQR 3–12), with a range from 1 day to 9.5 years.

Table 1 Overview of randomized controlled trials included in this reviewFig. 2

Map chart indicating the geographic distribution of the studies

Use of Goligher’s classification system

The vast majority (86.4%) of the studies used the Goligher classification system as criteria for patient selection (Table 1). However, 103 of these studies (73.6%) only mentioned grades II, III, or IV, or mixed hemorrhoids, without specifically naming Goligher, adequately defining the grading, or referencing Goligher’s published work [3]. Of the 140 reports using the Goligher classification, only 19 (13.6%) adequately referenced and mentioned the Goligher in their methods section where the inclusion criteria for patient selection were described. Additionally, six reports (4.3%) mentioned Goligher in the methods section without referencing the published work. In another six reports (4.3%), Goligher was mentioned in the introduction of the report, so it could be assumed that the grading in the methods or results section followed the Goligher classification system. In two reports, Goligher was adequately mentioned and referenced, but only in the results section. Four reports (2.9%) did not mention Goligher at all but fully described the grades and their definitions in the methods section, clearly indicating the patients selected for enrollment.

Use of other classification systems

In the 22 RCTs (13.6%) that did not reference the Goligher classification or the “grade” of hemorrhoids, various other inclusion criteria or classification systems were used for patient selection (Table 1). For example, two Italian studies utilized the Nivatvongs classification system, which not only assesses the structural prolapse similar to Goligher’s but also incorporates bleeding symptoms [13, 14]. In their RCT comparing diathermy hemorrhoidectomy with stapled anopexy, Gerjy et al. [15] proposed a new classification system, combining three items: (1) patient self-report of prolapse requiring manual reposition; (2) surgeon assessment of prolapse when the patient negated manual reposition; and (3) surgeon evaluation of the external component. This system categorizes prolapse as 1–3 (1 = no prolapse; 2 = spontaneously reducing prolapse; 3 = prolapse requiring manual repositioning) and the external component as A–C (A = no external component; B = one or few tags, C = circumferential). Subsequently, a large French study also adopted this classification system for patient inclusion [16]. Additionally, a 2002 study from Switzerland employed the Milles classification system [17], while a Chinese study selected patients on the basis of a clinical diagnosis of mixed hemorrhoids (veins above and below dental line) and Banov’s classification of grades III–IV internal hemorrhoids or symptomatic external hemorrhoids [18].

Studies without clear classification methodology

In 16 studies that did not explicitly reference the Goligher system or any other predefined classification systems, and did not use the term “grade” in their inclusion criteria, the criteria were based on a range of symptomatic and anatomical characteristics, along with patients’ treatment histories [19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34] (Table 1).

First, several studies focused on symptomatic and prolapsing hemorrhoids, both with and without external hemorrhoids, presenting with symptoms such as bleeding, hygiene difficulties, or discomfort. Some studies specifically included patients with thrombosed hemorrhoids or large hemorrhoids prone to permanent prolapse. Irreducible prolapse was a common criterion, with studies including patients with “three irreducible prolapsing piles” or “symptomatic prolapsed irreducible hemorrhoids.” Circumferential mixed hemorrhoids were also considered as a selection criterion.

Second, surgical candidacy was a significant inclusion factor in some studies, i.e., patients requiring invasive surgical treatment for their hemorrhoids. Additionally, a subset of studies focused on patients who had failed previous treatments, such as rubber band ligation, were fit for anesthesia, and without treatment preference.

Comparators across studies

Seventy-eight (48.1%) studies compared two or more excisional techniques (Table 1). Forty-five (27.8%) studies compared an excisional with a non-excisional surgical technique. Twenty-seven (16.7%) studies compared two non-excisional techniques, while seven (4.3%) compared an office-based procedure to an excisional surgical procedure. Six (3.7%) studies compared an office-based procedure to a non-excisional surgical procedure.

Main RCT study outcomes

Across the 162 clinical trials, a wide range of outcomes were evaluated. These are summarized in Fig. 3, which indicates the number of studies reporting on each outcome category. The majority of studies focused on pain (147 studies) and complications (133 studies). Among the 68 (42%) studies reporting on recurrence rates, 48 either lack detailed inclusion criteria or fail to reference the Goligher classification. In contrast, the remaining 20 studies that include recurrence as an outcome either provide appropriate inclusion criteria or reference the Goligher classification.

Fig. 3

Graph summarizing the categories of the reported study outcomes