Active — Not RecruitingNot Applicable

Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes

Italy100 participantsStarted 2024-12-01

Plain-language summary

This retrospective, single-center observational study will use routinely collected perioperative data from adults undergoing surgery for symptomatic hemorrhoidal disease to identify data-driven clinical phenotypes. Unsupervised machine learning will be applied to characterize clusters of patients based on demographic, clinical, anatomical, and surgical variables. The study will explore whether the resulting phenotypes differ in operative complexity and postoperative course, and will generate hypotheses to inform future predictive models and personalized surgical planning.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria * Age ≥ 18 years * Clinical and/or intraoperative diagnosis of symptomatic hemorrhoidal disease * Availability of complete perioperative data: demographic, clinical, surgical, and postoperative variables Exclusion criteria * Incomplete or missing clinical data * Presence of anorectal neoplastic conditions (e.g., anal or rectal carcinoma) * Anorectal surgery within the previous 6 months (to avoid confounding effects on symptoms and anatomy)

What they're measuring

Internal validity of the unsupervised clustering solution (silhouette coefficient)

Timeframe: From completion of dataset extraction/cleaning through completion of clustering analysis (retrospective analysis of surgeries performed December 2024 to June 2025)

Trial details

NCT IDNCT07427927

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Hemorrhoid trials