An observational study in Hemorrhoids, sponsored by Shanghai University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Shanghai University of Traditional Chinese Medicine · Observational
Hemorrhoidal disease is one of the most common anorectal conditions in China. However, there is currently no validated Chinese-language questionnaire that can comprehensively assess both hemorrhoid symptoms and their impact on patients' quality of life. This study aims to translate the Hemorrhoidal Disease Symptom Score (HDSS) and the Short Health Scale for Hemorrhoidal Disease (SHS-HD) into Mandarin Chinese and evaluate whether these questionnaires are reliable and appropriate for use in Chinese-speaking patients with hemorrhoids.
Adult patients diagnosed with hemorrhoidal disease will be recruited from the Department of Anorectal Surgery at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. Participants will complete the Chinese versions of the HDSS and SHS-HD questionnaires together with routine clinical assessments. Some participants will be asked to complete the questionnaires a second time approximately 14 days later to evaluate the consistency of their responses over time.
The findings of this study are expected to provide reliable and culturally appropriate Chinese-language questionnaires for evaluating hemorrhoid symptoms and the impact of the disease on patients' quality of life. These tools may support both clinical practice and future research involving Chinese-speaking patients with hemorrhoidal disease.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 115 is below the median of 151 across 49 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
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Patients diagnosed with hemorrhoidal disease who attend the outpatient clinic or are admitted to the inpatient ward of the Department of Anorectal Surgery at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dropout / Withdrawal Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Native Mandarin-speaking adult patients diagnosed with hemorrhoidal disease, recruited from the Department of Anorectal Surgery at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. Participants complete the Chinese versions of the HDSS and SHS-HD questionnaires.
Diagnostic Test: HDSS and SHS-HD Questionnaires
Administration of the Chinese versions of the Hemorrhoidal Disease Symptom Score (HDSS) and Short Health Scale for Hemorrhoidal Disease (SHS-HD) questionnaires. Participants complete both questionnaires during their clinic visit. No therapeutic intervention is administered.
Structural Validity the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
The structural validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be evaluated using confirmatory factor analysis (CFA) to examine the fit of the Chinese version to the original theoretical model. Model fit will be assessed using χ²/df (\<3 good, \<5 acceptable), comparative fit index (CFI ≥0.90), Tucker-Lewis index (TLI ≥0.90), root mean square error of approximation (RMSEA ≤0.08), and standardized root mean square residual (SRMR ≤0.08). If CFA demonstrates inadequate model fit, exploratory factor analysis (EFA) will be performed using principal component analysis with varimax rotation. Criteria include Kaiser-Meyer-Olkin (KMO) measure \>0.70, Bartlett's test of sphericity p\<0.05, eigenvalues \>1, and factor loadings \>0.40.
Time frame: Baseline
Structural Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
The structural validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be evaluated using confirmatory factor analysis (CFA) to examine the fit of the Chinese version to the original theoretical model. Model fit will be assessed using χ²/df (\<3 good, \<5 acceptable), comparative fit index (CFI ≥0.90), Tucker-Lewis index (TLI ≥0.90), root mean square error of approximation (RMSEA ≤0.08), and standardized root mean square residual (SRMR ≤0.08). If CFA demonstrates inadequate model fit, exploratory factor analysis (EFA) will be performed using principal component analysis with varimax rotation. Criteria include Kaiser-Meyer-Olkin (KMO) measure \>0.70, Bartlett's test of sphericity p\<0.05, eigenvalues \>1, and factor loadings \>0.40.
Time frame: Baseline
Internal Consistency of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
The internal consistency of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be assessed using Cronbach's alpha coefficient. A Cronbach's alpha value of ≥0.70 will be considered indicative of acceptable internal consistency.
Time frame: Baseline
Internal Consistency of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
The internal consistency of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be assessed using Cronbach's alpha coefficient. A Cronbach's alpha value of ≥0.70 will be considered indicative of acceptable internal consistency.
Time frame: Baseline
Test-Retest Reliability of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
The test-retest reliability of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be evaluated using the intraclass correlation coefficient (ICC; two-way mixed-effects model, absolute agreement) between baseline and the 14-day follow-up assessment. An ICC value of ≥0.80 will be considered indicative of good temporal stability.
Time frame: Baseline and 14 days
Test-Retest Reliability of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
The test-retest reliability of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be evaluated using the intraclass correlation coefficient (ICC; two-way mixed-effects model, absolute agreement) between baseline and the 14-day follow-up assessment. An ICC value of ≥0.80 will be considered indicative of good temporal stability.
Time frame: Baseline and 14 days
Known-Groups Validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
Known-groups validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) will be evaluated by comparing patients with mild hemorrhoidal disease (Goligher grade I/II) and severe hemorrhoidal disease (Goligher grade III/IV). The HDSS total score (range: 0-20, with higher scores indicating more severe hemorrhoidal symptoms) and individual item scores will be compared between groups using an independent-samples t-test for normally distributed data or the Mann-Whitney U test for non-normally distributed data. Effect sizes (Cohen's d or rank-biserial r) will also be reported. To account for multiple comparisons across nine indicators (five HDSS items and four SHS-HD items), Bonferroni correction will be applied with an adjusted significance level of α=0.0056.
Time frame: Baseline
Known-Groups Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
Known-groups validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) will be evaluated by comparing patients with mild hemorrhoidal disease (Goligher grade I/II) and severe hemorrhoidal disease (Goligher grade III/IV). The SHS-HD total score (range: 4-28, with higher scores indicating poorer hemorrhoid-related health-related quality of life) and individual dimension scores will be compared between groups using an independent-samples t-test for normally distributed data or the Mann-Whitney U test for non-normally distributed data. Effect sizes (Cohen's d or rank-biserial r) will also be reported. To account for multiple comparisons across nine indicators (five HDSS items and four SHS-HD items), Bonferroni correction will be applied with an adjusted significance level of α=0.0056.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared publicly because informed consent for public data sharing was not obtained and data sharing is restricted by the institutional ethics committee to protect participant privacy.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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