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

Starting soon

Conditions studied: Hemorrhoids

In brief

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.

Key facts

Study ID

NCT07713966

Run by

Shanghai University of Traditional Chinese Medicine

People needed

115

Starts

2026-07-15

Expected to finish

2027-07-01

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.