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

NCT07427927 | Active Not Recruiting

• 1 other identifier: CET 18-2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhoid; Hemorrhoid Prolapse

Keywords

Hemorrhoidal Disease; Unsupervised Machine Learning

Outcome Measures

Primary Outcomes (1)

• Internal validity of the unsupervised clustering solution (silhouette coefficient)

  Silhouette coefficient of the final k-means clustering solution derived from t-SNE-reduced perioperative data. The silhouette coefficient will be used as the primary internal validity metric to quantify cluster cohesion and separation for the selected number of clusters.

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

Secondary Outcomes (6)

• Cluster stability and reproducibility across model runs

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

• Operative duration (proxy of operative complexity)

  Intraoperative (day of surgery)

• Postoperative pain intensity

  From surgery to 6 month postoperatively

• Postoperative complications (Clavien-Dindo classification)

  From surgery to 1 month postoperatively (early complications) and up to 6 months postoperatively (late complications)

• Time to return to routine activities

  From surgery to 1 month postoperatively

Other Outcomes (3)

• Cluster separation metrics (beyond silhouette)

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

• Between-cluster differences in clinical/anatomical/surgical characteristics

  Baseline (preoperative assessment) and intraoperative (day of surgery)

• Post-hoc feature relevance for cluster formation

  From completion of dataset extraction/cleaning through completion of post-hoc feature relevance analyses (retrospective analysis of surgeries performed December 2024 to June 2025)

Study Arms (1)

patients who underwent surgery for symptomatic hemorrhoidal disease

Consecutive patients who underwent surgery for symptomatic hemorrhoidal disease at IRCCS Policlinico San Donato between December 2024 and June 2025. Consecutive enrollment was chosen to minimize selection bias and to represent the full spectrum of disease severity in the surgical setting. 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)

Procedure: Any surgical procedure for hemorrhoidal disease

Interventions

Any surgical procedure for hemorrhoidal disease PROCEDURE

standard hemorrhoidectomy, advanced hemorrhoidectomy, prolapsectomy, Doppler-guided procedures, or combined techniques

patients who underwent surgery for symptomatic hemorrhoidal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery for symptomatic hemorrhoidal disease

You may qualify if:

• Age ≥ 18 years
• Clinical and/or intraoperative diagnosis of symptomatic hemorrhoidal disease

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (16)

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• Xiao C, Hong S, Huang W. Optimizing graph layout by t-SNE perplexity estimation. Int J Data Sci Anal. 2023;15(2):159-171. doi:10.1007/s41060-022-00348-7

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• Goldenholz, D.M.; Sun, H.; Ganglberger, W.; Westover, M.B. Sample Size Analysis for Machine Learning Clinical Validation Studies. Biomedicines 2023, 11, 685. https://doi.org/10.3390/ biomedicines11030685

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• Robinson PN, Mungall CJ, Haendel M. Capturing phenotypes for precision medicine. Cold Spring Harb Mol Case Stud. 2015 Oct;1(1):a000372. doi: 10.1101/mcs.a000372.

  PMID: 27148566 BACKGROUND

• Brillantino A, Renzi A, Talento P, Brusciano L, Marano L, Grillo M, Maglio MN, Foroni F, Palumbo A, Sotelo MLS, Vicenzo L, Lanza M, Frezza G, Antropoli M, Gambardella C, Monaco L, Ferrante I, Izzo D, Giordano A, Pinto M, Fantini C, Gasparrini M, Schiano Di Visconte M, Milazzo F, Ferreri G, Braini A, Cocozza U, Pezzatini M, Gianfreda V, Di Leo A, Landolfi V, Favetta U, Agradi S, Marino G, Varriale M, Mongardini M, Pagano CEFA, Contul RB, Gallese N, Ucchino G, D'Ambra M, Rizzato R, Sarzo G, Masci B, Da Pozzo F, Ascanelli S, Liguori P, Pezzolla A, Iacobellis F, Boriani E, Cudazzo E, Babic F, Geremia C, Bussotti A, Cicconi M, Sarno AD, Mongardini FM, Brescia A, Lenisa L, Mistrangelo M, Zuin M, Mozzon M, Chiriatti AP, Bottino V, Ferronetti A, Rispoli C, Carbone L, Calabro G, Tirro A, de Vito D, Ioia G, Lamanna GL, Asciore L, Greco E, Bianchi P, D'Oriano G, Stazi A, Antonacci N, Renzo RMD, Poto GE, Ferulano GP, Longo A, Docimo L. The Italian Unitary Society of Colon-Proctology (Societa Italiana Unitaria di Colonproctologia) guidelines for the management of acute and chronic hemorrhoidal disease. Ann Coloproctol. 2024 Aug;40(4):287-320. doi: 10.3393/ac.2023.00871.0124. Epub 2024 Aug 30.

  PMID: 39228195 BACKGROUND

• De Gregorio MA, Guirola JA, Serrano-Casorran C, Urbano J, Gutierrez C, Gregorio A, Sierre S, Ciampi-Dopazo JJ, Bernal R, Gil I, De Blas I, Sanchez-Ballestin M, Millera A. Catheter-directed hemorrhoidal embolization for rectal bleeding due to hemorrhoids (Goligher grade I-III): prospective outcomes from a Spanish emborrhoid registry. Eur Radiol. 2023 Dec;33(12):8754-8763. doi: 10.1007/s00330-023-09923-3. Epub 2023 Jul 17.

  PMID: 37458757 BACKGROUND

• van Oostendorp JY, Grossi U, Hoxhaj I, Kimman ML, Kuiper SZ, Breukink SO, Han-Geurts IJM, Gallo G. Limitations of the Goligher classification in randomized trials for hemorrhoidal disease: a qualitative systematic review of selection criteria. Tech Coloproctol. 2025 Jun 10;29(1):133. doi: 10.1007/s10151-025-03170-y.

  PMID: 40493094 BACKGROUND

• Dekker L, Han-Geurts IJM, Grossi U, Gallo G, Veldkamp R. Is the Goligher classification a valid tool in clinical practice and research for hemorrhoidal disease? Tech Coloproctol. 2022 May;26(5):387-392. doi: 10.1007/s10151-022-02591-3. Epub 2022 Feb 9.

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• Al-Masoudi RO, Shosho R, Alquhra D, Alzahrani M, Hemdi M, Alshareef L. Prevalence of Hemorrhoids and the Associated Risk Factors Among the General Adult Population in Makkah, Saudi Arabia. Cureus. 2024 Jan 3;16(1):e51612. doi: 10.7759/cureus.51612. eCollection 2024 Jan.

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• Error in Figure 4 and References. JAMA. 2025 Oct 7;334(13):1203. doi: 10.1001/jama.2025.17752. No abstract available.

  PMID: 40952854 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 23, 2026
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)