Published online Oct 21, 2026. doi: 10.3748/wjg.121904
Revised: June 29, 2026
Accepted: July 20, 2026
Published online: October 21, 2026
Processing time: 159 Days and 8.6 Hours
Foam sclerotherapy is an effective minimally invasive treatment for grade I internal hemorrhoids, but recurrence limits long-term benefit and no validated endoscopic tool is available for individualized risk prediction.
To develop and validate an endoscopy-based score for predicting recurrence after foam sclerotherapy in patients with grade I internal hemorrhoids.
In this prospective, multicenter observational cohort, consecutive adults with grade I internal hemorrhoids treated with 1% polidocanol foam were enrolled. A Cox model was developed from clinical and standardized endoscopic predictors. Discrimination, calibration, bootstrap internal validation, and 36-month decision curve analysis were assessed. The unchanged model was evaluated in an independent external cohort, and a separate cohort provided exploratory endoscopic and histopathological biological verification.
A total of 483 patients were included in model development; 115 developed recurrences during follow-up, with cumulative recurrence rates of 10.1% at 24 months and 20.0% at 36 months. The weighted continuous Endoscopic Hemorrhoid Recurrence Score (Endo-HRS) was: Endo-HRS = 1 × male sex + 4 × number of hemorrhoids + 11 × maximum hemorrhoid diameter (cm) + 2 × red color sign grade (0-3). A nomogram estimated individual 36-month recurrence probability. Discrimination was good in development (C-index = 0.82; continuous-model 36-month area under the curve = 0.88) and external validation (n = 279; bootstrap-corrected C-index = 0.90, 95% confidence interval: 0.862-0.933). Exploratory endoscopic and histopathological findings were directionally consistent with higher-risk groups.
Endo-HRS is a weighted endoscopy-based recurrence score with encouraging internal and external performance. It may support risk stratification and inform future evaluation of risk-adapted follow-up, but its clinical impact requires prospective assessment.
Core Tip: In this prospective multicenter study, we developed and externally evaluated Endoscopic Hemorrhoid Recurrence Score (Endo-HRS), a weighted continuous score based on sex, number of hemorrhoids, maximum hemorrhoid diameter, and red color sign grade. The model showed good discrimination in the development and external cohorts, and a nomogram estimates individual 36-month recurrence probability. Exploratory endoscopic and histopathological findings supported biological plausibility. Endo-HRS may aid risk stratification, although prospective impact studies are required before it is used to direct surveillance or retreatment.
- Citation: Zhang FY, Xu LM, Gao FY, Wang W, Lin WL, Zhang H, Wang KZ, Wang QJ, Jin AJ, Yang RP, Qu CY, Zhang Y, Li ZH, Wang D, Shi CC, Shen TB, Shen F, Hu Y, Shen F. Endoscopic score predicting recurrence after foam sclerotherapy in grade I internal hemorrhoids: Development and external validation. World J Gastroenterol 2026; 32(39): 121904
- URL: https://www.wjgnet.com/1007-9327/full/v32/i39/121904.htm
- DOI: https://dx.doi.org/10.3748/wjg.121904
Internal hemorrhoids, characterized by symptomatic enlargement or distal displacement of the anal vascular cushions, are among the most common anorectal disorders. The main clinical manifestations are bleeding, prolapse, and discomfort[1,2]. Available treatments range from conservative measures to definitive surgical intervention[3,4]. Among minimally invasive options, endoscopic foam sclerotherapy with polidocanol has attracted growing interest because of its pro
Endoscopic polidocanol-based therapies have recently emerged as effective minimally invasive approaches for internal hemorrhoids[10,11]. A multicenter randomized study demonstrated favorable efficacy and safety, with rapid recovery and low complication rates[12-14]. Nevertheless, recurrence after treatment remains an unresolved problem, and reliable tools for individualized risk stratification are lacking.
Conventional grading does not fully characterize the endoscopic phenotype of hemorrhoidal disease[15,16]. The Goligher classification is driven primarily by prolapse and has recognized limitations for clinical research, whereas pathophysiological and symptom-oriented frameworks remain mainly descriptive[17-21]. Standardized endoscopic as
A prospective, multicenter, observational cohort study was conducted to develop and externally validate an endoscopic prediction model for recurrence after foam sclerotherapy for grade I internal hemorrhoids, in line with the STROBE reporting framework[24]. Consecutive patients were enrolled between January 2018 and December 2022 at four tertiary gastroenterology and endoscopy centers in China: Xinhua Hospital, Shandong Provincial Maternal and Child Health Care Hospital, the 900th Hospital of the PLA Joint Service Support Force, and Baoshan People’s Hospital.
The target sample size was determined according to the expected number of recurrence events required for mul
Eligible participants were adults aged 18-70 years with endoscopically confirmed Goligher grade I internal hemorrhoids who underwent 1% (20 mg/2 mL) polidocanol (Aethoxysklerol; Hameln Pharmaceuticals, Germany) foam sclerotherapy. Key exclusion criteria included grade II-IV or external hemorrhoids, concomitant anorectal or perianal disease, contraindications to sclerotherapy, and other protocol-defined ineligibility criteria. Detailed inclusion and exclusion criteria are provided in Supplementary Tables 1 and 2. Chronic constipation or straining, prolonged sitting or standing, alcohol and spicy-food exposure, and pregnancy or childbirth history were not prospectively collected using standardized definitions and therefore were not entered into the primary model. All participants provided written informed consent in accordance with the Declaration of Helsinki[25]. The study was prospectively registered at ClinicalTrials.gov (No. NCT04398823).
Patients followed a low-fiber diet on the day before colonoscopy and underwent split-dose bowel preparation with polyethylene glycol solution (Hengkangzhengqing; Hygecon, Shangrao, Jiangxi Province, China) according to European Society of Gastrointestinal Endoscopy recommendations[26]. Foam sclerotherapy was performed using a standardized technique[12]. Specifically, 1% polidocanol was prepared using Tessari et al’s method[27] and injected through a 25-gauge InterjectTM needle (Boston Scientific, Marlborough, MA, United States) under endoscopic visualization (H290 series, Olympus, Tokyo, Japan).
Two experienced endoscopists completed standardized training and independently recorded the prespecified baseline endoscopic variables before consensus resolution. These variables included number of hemorrhoids, maximum he
All patients underwent a minimum follow-up of 6 months, with scheduled clinic visits at 3-month intervals. Each visit included a clinical interview, digital rectal examination, and standardized questionnaire assessment (Supplementary Table 3). Protocolized surveillance colonoscopy was performed every 6 months irrespective of symptoms. Endoscopic confirmation was mandatory for suspected recurrence, and all re-examination records were collected prospectively.
Time to recurrence was recorded in months. Thirty-six months was the prespecified primary prediction horizon rather than the maximum observation period. Participants were followed until confirmed recurrence, last documented contact, or administrative censoring on December 31, 2025; non-recurrent participants could be observed beyond 36 months. The maximum development-cohort follow-up was 87 months. The primary endpoint was endoscopically confirmed reap
Candidate predictors were prespecified according to clinical and endoscopic relevance and then summarized using univariable Cox proportional hazards models. Variables with P < 0.10 and prespecified clinically relevant variables were considered in multivariable Cox modeling. Backward selection was used for the final model, and its potential for model instability and optimism is acknowledged. The proportional hazards assumption was assessed using Schoenfeld residuals. The functional form of maximum hemorrhoid diameter was assessed using restricted cubic splines, with nonlinearity-test result 0.638. Full regression coefficients, standard errors, hazard ratios, 95% confidence intervals (CIs), P values, and baseline survival estimates are reported in Supplementary Table 4.
The Endo-HRS was constructed as a weighted continuous risk score derived from the rescaled Cox linear predictor; decimal values are possible because maximum hemorrhoid diameter is entered in centimeters. Model discrimination was assessed using Harrell’s concordance index and time-dependent receiver operating characteristic curves. Calibration was assessed using plots, calibration slope, integrated Brier score, and the 36-month Brier score. Internal validation used 1000 bootstrap resamples to estimate optimism and optimism-corrected performance. Clinical utility at 36 months was evaluated by decision curve analysis against treat-all and treat-none strategies[28,29]. Apparent, internal, and external performance metrics are summarized in Supplementary Table 5.
Thresholds were derived from the 36-month time-dependent receiver operating characteristic analysis. The lower rule-out threshold and upper rule-in threshold defined the three-tier classification: Group A, < 18.2; Group B, 18.2 to < 27.4; and group C, ≥ 27.4. The Youden-optimized threshold of 22.8 is reported as a separate binary reference and was not the sole basis for the three-tier grouping. Recurrence-free interval among groups was compared using Kaplan-Meier analysis.
A web-based calculator was implemented to generate the weighted Endo-HRS and classify patients into groups A, B, and C. The calculator is available at https://feiyuzhang.shinyapps.io/EndoHRS-Calculator/. The website is an optional implementation rather than the sole method of calculation; the complete formula and a printable worksheet are provided in Supplementary Table 6. The corresponding authors plan to maintain the web application for every six months and will provide source code or an offline calculator upon reasonable request if the website becomes unavailable.
The external cohort included 291 patients screened between January and December 2022 at five contributing external centers: The Ninth People’s Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai Tongren Hospital, Shanghai Construction Engineering Hospital, The Fifth People’s Hospital of Ganzhou City, Jiangxi Province, and Shigatse People’s Hospital. This constituted geographic validation. The same predictor and outcome definitions were used, and no external-cohort data were used for model development, coefficient estimation, or refitting. The external cohort included 60 recurrence events, with median potential follow-up of 33.2 months (95%CI: 32.4-34.1), administrative censoring on December 31, 2025, and maximum follow-up of 48 months. Baseline characteristics are presented in Supplementary Table 7.
The original Cox model was applied to the external cohort without refitting. Individual linear predictors and absolute risks were calculated using the development-cohort coefficients and baseline survival. Discrimination was evaluated using the C-index with 95%CI from 1000 bootstrap resamples and time-dependent receiver operating characteristic analysis at 24 months, 36 months, and 48 months. Calibration at 36 months was assessed using grouped estimates, logit-locally estimated scatterplot smoothing, calibration intercept, calibration slope, and Brier score. Decision curve analysis was also evaluated at the 36-month horizon.
A separate exploratory biological-verification cohort comprised 40 participants who were not included in the deve
Hemorrhoid tissue biopsies were obtained using standard forceps and processed for hematoxylin-eosin and Masson’s trichrome staining to characterize venous congestion and collagen deposition. Microvascular features and collagen-proportionate area were quantified using ImageJ software[30].
Continuous variables were summarized as mean ± SD or median (interquartile range), as specified, and categorical variables as frequencies (%). Group comparisons used the χ2 test, Wilcoxon rank-sum test, or other appropriate methods. Age was reported consistently as median (interquartile range).
All baseline predictor variables were completely recorded, and therefore no imputation was performed. The nine development-cohort and seven external-cohort participants lost before completion of the minimum follow-up were excluded from the primary time-to-event analyses and are shown in Figure 2. Complete-case analyses were used as sensitivity analyses. Median potential follow-up was estimated using the reverse Kaplan-Meier method, and censoring distributions were examined. Sensitivity analyses assessed the stricter bleeding-confirmed recurrence endpoint, exclusion of sex from the model, and complete-case vs imputed estimates. All analyses were performed in R (version 4.5.1; R Foundation for Statistical Computing, Vienna, Austria) and SPSS (version 27.0; IBM Corp., Armonk, NY, United States). Relevant R packages are listed in Supplementary Table 8. Custom scripts are available from the corresponding authors upon reasonable request. Statistical significance was defined as P < 0.05.
A total of 504 patients with grade I internal hemorrhoids were prospectively enrolled in the development cohort. Twelve were excluded because of protocol-defined ineligibility, current anticoagulant or antiplatelet therapy, or inadequate retroflexed visualization. Nine were lost before completion of the minimum follow-up. Consequently, 483 patients were included in the primary development analysis (Figure 2A and Supplementary Table 9).
The cohort comprised 50.9% (246/483) male patients, with a median age of 52.5 years (interquartile range, 11.8 years). During the full available follow-up, recurrence was documented in 23.8% (115/483). Age did not differ between the recurrence and non-recurrence groups [55.0 (interquartile range, 21.0) years vs 55.0 (interquartile range, 18.0) years, P = 0.82]. The proportion of male patients was higher in the recurrence group [61.7% (71/115)] than in the non-recurrence group [47.6% (175/368), P = 0.008]. Observed follow-up was shorter in patients with recurrence because observation ended at relapse (27.4 ± 9.3 months vs 61.0 ± 11.0 months, P < 0.0001) (Table 1).
The reverse Kaplan-Meier median potential follow-up was 61.0 months (95%CI: 58.9-63.1). Of 483 patients, 368 were censored without a documented recurrence. Censoring occurred predominantly after prolonged observation (Supple
At baseline, the recurrence group had more hemorrhoids (P < 0.0001); 86.1% (99/115) had three or more hemorrhoids compared with 52.7% (194/368) in the non-recurrence group. The recurrence group also had larger maximum hemorrhoid diameters (P < 0.0001) and more grade 2-3 red color signs (38.3% vs 17.1%, P < 0.0001). Mucosal erosion (P = 0.25) and dentate-line injury (P = 0.26) did not differ significantly (Tables 2 and 3).
| Group | Number of hemorrhoids | Maximum hemorrhoid diameter | ||||||
| 1 | 2 | 3 | 4 | 5 | < 0.8 cm | 0.8 cm ≤ diameter < | ≥ 1.2 cm | |
| Recurrence (n = 115) | 0 (0.0) | 16 (13.9) | 72 (62.6) | 26 (22.6) | 1 (0.9) | 4 (3.5) | 71 (61.7) | 40 (34.8) |
| No recurrence (n = 368) | 31 (8.4) | 143 (38.9) | 183 (49.7) | 11 (3.0) | 0 (0.0) | 126 (34.2) | 202 (54.9) | 40 (10.9) |
| Group | Red color sign grade | Mucosal erosion | Dentate-line injury | ||||||
| 0 | 1 | 2 | 3 | No | Yes | 0 | < 0.5 cm | ≥ 0.5 cm | |
| Recurrence (n = 115) | 5 (4.3) | 66 (57.4) | 31 (27.0) | 13 (11.3) | 105 (91.3) | 10 (8.7) | 101 (87.8) | 11 (9.6) | 3 (2.6) |
| No recurrence (n = 368) | 153 (41.6) | 152 (41.3) | 63 (17.1) | 0 (0.0) | 347 (94.3) | 21 (5.7) | 336 (91.3) | 26 (7.1) | 6 (1.6) |
Number of hemorrhoids, maximum hemorrhoid diameter, and red color sign grade were strong predictors in the multivariable model (all P < 0.0001). Male sex did not reach conventional statistical significance (P = 0.08) and is therefore interpreted as a borderline, exploratory component rather than an established independent recurrence factor. It was retained because it was prespecified, its effect direction was clinically plausible, men were overrepresented among recurrent cases, and inclusion did not materially impair overall model performance. All four variables satisfied the proportional hazards assumption (Figure 3).
The continuous Cox model had an apparent C-index of 0.82 (SE = 0.017), with time-dependent area under the curves (AUCs) of 0.92, 0.93, and 0.88 at 12 months, 24 months, and 36 months, respectively (Supplementary Figure 3 and Supplementary Table 5). The 36-month AUC of 0.86 refers to the simplified three-tier clinical classification rather than the continuous Cox model. At 36 months, the reported calibration-in-the-large was -2.51 and the calibration slope was 1.34, indicating systematic underestimation of absolute risk; the 36-month Brier score was 0.112. Bootstrap optimism-corrected performance and external metrics are summarized in Supplementary Table 5. Decision curve analysis showed a positive net benefit across threshold probabilities of 2%-50%, consistently outperforming both the treat-all and treat-none strategies (Supplementary Figure 4).
The Cox coefficients were rescaled relative to the coefficient for sex and rounded to generate the clinical weights. Because diameter is entered in centimeters as a continuous value, Endo-HRS (formula 1) is a weighted continuous score and may contain decimals. The complete model specification and the absolute-risk equation are provided in Supplementary Table 4. Endo-HRS = 1 × sex (male) + 4 × number of hemorrhoids + 11 × maximum hemorrhoid diameter (cm) + 2 × red color sign grade (0-3) formula 1. Endo-HRS weighted continuous score.
Quartile-based groups were explored initially (Supplementary Table 10). For clinical presentation, groups A (< 18.2), B (18.2 to < 27.4), and C (≥ 27.4) were defined by lower rule-out and upper rule-in thresholds (Supplementary Table 11). The Youden-optimized threshold of 22.8 is a separate binary reference. The three-tier classification had a 36-month AUC of 0.86 (Figure 4A), recurrence-free interval decreased across groups (Figure 4B), and a nomogram estimated individual 36-month recurrence probability (Figure 4C).
The web calculator outputs the total score and risk group (Supplementary Figure 5). A printable calculation sheet with a worked example is provided in Supplementary Table 6, allowing manual use if the website is temporarily unavailable. Long-term maintenance and offline access are described in the “METHODS”.
In the external cohort, 291 patients were screened and 279 were analyzed after five exclusions and seven losses before completion of the minimum follow-up (Figure 2B). The cohort was recruited at five contributing external centers and included 60 recurrence events during a median potential follow-up of 33.2 months (95%CI: 32.4-34.1). Endo-HRS showed a bootstrap-corrected C-index of 0.900 (95%CI: 0.862-0.933), with time-dependent AUCs of 0.90, 0.94, and 0.95 at 24 months, 36 months, and 48 months, respectively (Figure 5A). Calibration was visually acceptable, with the slope of 0.97, and 36-month Brier score of 0.10 (Supplementary Figure 6 and Supplementary Table 5). Group C had a shorter recurrence-free interval than groups A and B (P < 0.0001; Figure 5B).
In the sensitivity analysis restricted to recurrent bleeding with endoscopically confirmed hemorrhoids, predictor effects and model performance remained directionally consistent and verified C-index, AUC, and calibration values remained stable (Supplementary Table 12).
The exploratory biological-verification cohort included 40 participants: 9 in group A, 24 in group B, and 7 in group C (Supplementary Table 13). All contributed endoscopic images; quantitative Masson analysis included 15 adequate specimens, with 5 per group. The small and imbalanced group sizes limit statistical power.
Endoscopic images in higher-risk groups showed more prominent red color signs, more hemorrhoids, and larger diameters (Figure 6A-C). These cross-sectional findings were consistent with the variables encoded in Endo-HRS but do not constitute independent validation of predictive performance.
Representative histopathology showed greater dilation and congestion of submucosal venules in group C (Figure 6D-F). Masson’s trichrome staining showed higher collagen-proportionate area in higher-risk groups; group C values were 14.6-fold and 2.6-fold those of groups A and B, respectively (Figure 6G-I, Supplementary Figure 7 and Supplementary Table 14). These exploratory, cross-sectional observations support biological plausibility but do not establish that vascular or extracellular-matrix changes cause recurrence.
This prospective multicenter study evaluated long-term recurrence after 1% polidocanol foam sclerotherapy for grade I internal hemorrhoids and developed a weighted continuous score from standardized endoscopic features. Building on evidence supporting endoscopic polidocanol therapy[12-14,31], the study addresses the unmet need for transparent recurrence-risk estimation while providing external evaluation and exploratory biological support.
Recurrence increased progressively over time, with cumulative rates of 2.5%, 10.1%, and 20.0% at 12 months, 24 months, and 36 months, respectively. These findings are broadly consistent with prior reports[6,32], although previous studies largely used 3% polidocanol and focused on grade II-III disease[6,32-35]. In our cohort, 1% polidocanol foam maintained durable efficacy in grade I disease, and no severe procedure-related adverse events were recorded.
Despite the substantial burden of hemorrhoidal disease[36], validated tools for individualized prediction of recurrence after endoscopic therapy remain scarce. The Goligher classification is based primarily on the degree of prolapse and has shown only fair interobserver agreement; moreover, it does not capture other potentially relevant phenotypic dimen
Male sex was retained as a borderline exploratory predictor rather than being interpreted as a proven independent determinant of post-sclerotherapy recurrence. Direct evidence specifically linking male sex to recurrence after 1% polidocanol foam sclerotherapy for grade I internal hemorrhoids remains limited. However, in the prospective mul
The lower and upper operating thresholds provide a simple three-tier presentation, while 22.8 remains a separate Youden-optimized binary reference. These groups may aid communication of relative risk and hypothesis generation for future management studies. They should not yet be interpreted as prospectively validated instructions for surveillance intensity or retreatment, because no impact trial compared Endo-HRS-guided care with usual practice.
The exploratory multimodal component provides biological context rather than definitive validation. Hemorrhoidal disease is increasingly recognized as a degenerative disorder of the anal cushion characterized by vascular remodeling and extracellular-matrix dysregulation[18,19,39]. Chronic venous hypertension and microcirculatory disturbance may lead to persistent venous dilation and structural remodeling of hemorrhoidal plexuses. At the molecular level, imbalance in extracellular-matrix turnover, including dysregulated collagen synthesis and degradation mediated by matrix metalloproteinase pathways, may contribute to tissue weakening and remodeling[39]. Genome-wide analyses further support a genetically determined component involving vascular development, smooth-muscle function, epithelial/endothelial biology, and extracellular-matrix organization pathways[38]. In addition, extracellular-matrix dynamics and collagen remodeling are central regulators of connective-tissue structure and vascular homeostasis[40], while collagen fiber reorganization, mechanical stress propagation, and cell-matrix interactions can drive tissue remodeling and structural adaptation[40,41]. Within this framework, the observed venous congestion, hemorrhoid burden, red color signs, and collagen differences likely represent macroscopic manifestations of underlying vascular and extracellular-matrix re
This study has several limitations. First, development was restricted to Chinese patients with grade I internal hemorrhoids treated with 1% polidocanol foam, limiting generalizability to other populations, grades, and therapies. Second, constipation, occupational exposure, diet, pregnancy and childbirth history, and other patient-level factors were not prospectively captured with standardized definitions; future model updating should evaluate their incremental value. Third, the high-specificity endoscopic recurrence definition reduces misclassification from non-hemorrhoidal symptoms but may underestimate the broader symptomatic burden. Conceptual overlap remains possible between baseline red color sign and follow-up vascular abnormalities, despite temporal separation, blinded adjudication, and the prespecified sensitivity analysis. Fourth, endoscopic variables were independently evaluated during routine clinical assessment, with discrepancies resolved by consensus. However, only the consensus findings were retained in the final analytical dataset, and the individual pre-consensus ratings were not archived. Consequently, formal measures of in
Endo-HRS is a weighted continuous endoscopy-based score with encouraging development and external-validation performance after foam sclerotherapy for grade I internal hemorrhoids. It may aid recurrence-risk stratification and support the design of future risk-adapted follow-up studies; prospective impact evaluation is required before it is used to direct surveillance or retreatment.
The authors thank all patients for participating and for permitting the use of their treatment and follow-up data. The authors also thank the medical statistics team of Xinhua Hospital for methodological support. All authors take responsibility for the integrity of the work.
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