Limitations of the Goligher classification in randomized trials for hemorrhoidal disease: a qualitative systematic review of selection criteria.

Abstract

Background: The diverse range of therapeutic options for hemorrhoidal disease (HD) highlights the need for precise classification systems to guide treatment. Although the Goligher classification remains the most widely used, it has been criticized for its simplicity and limited ability to capture symptom severity or guide treatment decisions. This study aims to evaluate the patient selection criteria and classification systems employed in randomized controlled trials (RCTs) for HD.

Methods: A systematic review was conducted following the 2020 PRISMA guidelines. A comprehensive search of databases identified randomized controlled trials (RCTs) comparing treatments for HD, focusing on classification systems used for patient enrollment. Eligible studies included adult patients and at least one arm involving surgical treatment.

Results: Out of 6692 records, 162 studies met the inclusion criteria, with a median cohort size of 84 patients and 55.4% male. Most studies (86.4%) used the Goligher system, though the majority did not fully describe or cite the system. Only 13.6% of studies employed more recent alternative classification systems. The most common outcome measures across studies were postoperative pain (147 studies) and complications (133 studies). Recurrence rates were reported in 42% of studies, yet 70% of these did not provide adequate inclusion criteria or references to Goligher's classification.

Conclusions: The inconsistent application of the Goligher classification and the variability in patient selection criteria across RCTs highlight the need for more nuanced and standardized systems. Future research should focus on refining classification methods and incorporating patient-reported outcomes to improve the reliability and relevance of HD trials.

Prospero registration: CRD42023387339.