HemorrhoidsNCT07713966
Validation of HDSS and SHS-HD in Chinese Patients With Hemorrhoids
An observational study of Hemorrhoids, run by Shanghai University of Traditional Chinese Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- HDSS and SHS-HD Questionnaires
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Diagnosed with hemorrhoidal disease according to the 2020 Chinese Guidelines for Diagnosis and Treatment of Hemorrhoids.
- Aged 18 to 60 years, inclusive, regardless of sex.
- Able to understand the study and willing to provide written informed consent.
- Native Mandarin speaker.
Who cannot join
- Severe visual or hearing impairment, education level below primary school (illiterate or semi-literate), or cognitive/social dysfunction that prevents completion of the questionnaire assessments.
- Concurrent inflammatory bowel disease or anal fistula.
- Major systemic comorbidity that may interfere with study participation.
- Dropout / Withdrawal Criteria:
- Voluntary withdrawal from the study without prior notice, or loss to follow-up.
- Active request to withdraw from the study, or failure to cooperate with questionnaire completion after providing informed consent.
About this study
Official title: Translation and Validation of the Hemorrhoid Disease Symptom Score (HDSS) and Short Health Scale for Hemorrhoid Disease (SHS-HD) in Chinese Patients With Hemorrhoids
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.
- Conditions
- Hemorrhoids
- Being tested
- HDSS and SHS-HD Questionnaires
- Keywords
- HDSS, SHS-HD, Quality of Life, Questionnaire Validation, Patient-Reported Outcome Measures, Chinese Translation
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDSS and SHS-HD QuestionnairesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Patients with Hemorrhoids | 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. Receives: Diagnostic Test: HDSS and SHS-HD Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengyi Wang, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713966
- Sponsor's protocol ID
- 2026-194
- Other IDs
- 202540035, 2026-194
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Hemorrhoid Disease Symptom Score (HDSS) and Short Health Scale for Hemorrhoid Disease (SHS-HD) in Chinese Patients With Hemorrhoids
- ClinicalTrials.gov ID
- NCT07713966
- Acronym / sponsor ID
- 2026-194
- Conditions
- Hemorrhoids
- Keywords
- HDSS, SHS-HD, Quality of Life, Questionnaire Validation, Patient-Reported Outcome Measures, Chinese Translation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Patients with Hemorrhoids | – | Diagnostic Test: HDSS and SHS-HD QuestionnairesNative 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Diagnosed with hemorrhoidal disease according to the 2020 Chinese Guidelines for Diagnosis and Treatment of Hemorrhoids.
- Aged 18 to 60 years, inclusive, regardless of sex.
- Able to understand the study and willing to provide written informed consent.
- Native Mandarin speaker.
Key exclusion criteria (6 listed)
- Severe visual or hearing impairment, education level below primary school (illiterate or semi-literate), or cognitive/social dysfunction that prevents completion of the questionnaire assessments.
- Concurrent inflammatory bowel disease or anal fistula.
- Major systemic comorbidity that may interfere with study participation.
- Voluntary withdrawal from the study without prior notice, or loss to follow-up.
- Active request to withdraw from the study, or failure to cooperate with questionnaire completion after providing informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDSS and SHS-HD QuestionnairesAdministration 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. | Diagnostic test | Chinese Patients with Hemorrhoids |
Primary outcome
Structural Validity the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
Time frame: Baseline
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.
Structural Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
Time frame: Baseline
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.
Internal Consistency of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
Time frame: Baseline
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.
Internal Consistency of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
Time frame: Baseline
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.
Test-Retest Reliability of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
Time frame: Baseline and 14 days
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.
Test-Retest Reliability of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
Time frame: Baseline and 14 days
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.
Known-Groups Validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS)
Time frame: Baseline
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.
Known-Groups Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD)
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids, run by Shanghai University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Validity the Chinese Hemorrhoidal Disease Symptom Score (HDSS) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.