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Not yet recruiting NCT07713966

Validation of HDSS and SHS-HD in Chinese Patients With Hemorrhoids

— Observational Hemorrhoids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDSS and SHS-HD Questionnaires.
Who it may be relevant to
Registry conditions: Hemorrhoids. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Structural Validity the Chinese Hemorrhoidal Disease Symptom Score (HDSS) [Time frame: Baseline]
  • Structural Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) [Time frame: Baseline]
  • Internal Consistency of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) [Time frame: Baseline]
  • Internal Consistency of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) [Time frame: Baseline]
  • Test-Retest Reliability of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) [Time frame: Baseline and 14 days]
  • Test-Retest Reliability of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) [Time frame: Baseline and 14 days]
  • Known-Groups Validity of the Chinese Hemorrhoidal Disease Symptom Score (HDSS) [Time frame: Baseline]
  • Known-Groups Validity of the Chinese Short Health Scale for Hemorrhoidal Disease (SHS-HD) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07713966 · 2026-194 · 202540035 · 2026-194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗