This observational cohort study developed and externally validated an endoscopic hemorrhoid recurrence score (Endo-HRS) to predict recurrence after foam sclerotherapy for grade I internal hemorrhoids. The study included 483 patients in the development cohort and 279 patients in the external validation cohort from four tertiary hospitals, with follow-up extending to 36 months. The primary outcome was recurrence of internal hemorrhoids, with no comparator group reported.
Cumulative recurrence rates after foam sclerotherapy were 0.62% at 6 months, 2.48% at 12 months, 10.1% at 24 months, and 20.0% at 36 months. The Endo-HRS model, which incorporates the number of hemorrhoids, maximum diameter, red color sign, and patient sex, demonstrated good discriminative ability with a C-index of 0.82 and AUC >0.80. The model stratified patients into three risk categories based on scores: <18.2, 18.2-27.4, and ≥27.4. Pathological analysis of recurrent lesions revealed submucosal microvascular congestion and aberrant deposition of extracellular matrix components.
Safety and tolerability data were not reported. Key limitations include lack of model recalibration, limited generalizability beyond tertiary hospital settings, need for larger external and in vivo validation, and lack of unity among observers. Funding and conflicts of interest were not reported.
For practice, the Endo-HRS model provides individualized recurrence risk stratification after endoscopic treatment to guide clinical management. However, clinicians should recognize this is an observational study identifying associations, not causation. The model requires further validation before widespread clinical use, and its predictive certainty should not be overstated given the study's limitations.
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BACKGROUNDThe primary drawback of endoscopic foam sclerotherapy for grade I internal hemorrhoids is the high rate of recurrence. However, the pathological mechanisms underlying recurrence and reliable endoscopic predictive markers remain poorly defined.
OBJECTIVEThe study aimed to identify predictive factors and develop a novel endoscopic model to stratify recurrence risk following foam sclerotherapy for grade I internal hemorrhoids.
DESIGNMulticenter, prospective, observational cohort study.
SETTINGSThis study was conducted at four tertiary hospitals.
PATIENTS483 patients with grade I internal hemorrhoids were enrolled and received foam sclerotherapy. 279 patients were independently enrolled for external validation.
INTERVENTIONSFoam sclerotherapy was administered for patients.
MAIN OUTCOME MEASURESThe end point was recurrence of internal hemorrhoids.
RESULTSCumulative recurrence rates were 0.62%, 2.48%, 10.1%, and 20.0% at 6, 12, 24, and 36 months, respectively. The number of hemorrhoids, maximum hemorrhoid diameter, red color sign, and patient sex were identified as independent predictors and comprised the Endoscopic Hemorrhoid Recurrence Score (Endo-HRS) model. The model demonstrated strong discriminative ability (C-index=0.82; AUC>0.80) and stratified patients into three distinct risk categories (score <18.2, 18.2-27.4, [≥]27.4) for personalized follow-up. A web-based calculator was developed for clinical implementation. Pathological analysis of recurrent lesions revealed submucosal microvascular congestion and aberrant deposition of extracellular matrix components.
LIMITATIONSLimitations include lack of recalibration, generalizability, larger external and in vivo validation, and unity among observers.
CONCLUSIONSThe Endo-HRS model effectively stratifies recurrence risk following foam sclerotherapy for grade I internal hemorrhoids. The findings underscore the pathological contribution of abnormal extracellular matrix remodeling and excessive collagen deposition to recurrence. This tool addresses a significant gap in endoscopic hemorrhoid management by enabling individualized preoperative risk assessment and informing tailored treatment strategies.
CLINICAL TRIAL REGISTRATION NUMBER: NCT04398823.See Video Abstract.
LEGENDSO_ST_ABSGraphical AbstractC_ST_ABSPatients with Golighers grade I internal hemorrhoids receiving foam sclerotherapy were analyzed for endoscopic and clinical features. The Endoscopic Hemorrhoid Recurrence Score (Endo-HRS) was developed and externally validated with independent cohorts and endoscopic/histopathological correlation. Endo-HRS provides individualized recurrence risk stratification after endoscopic treatment to guide clinical management.
