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Набор скоро начнётся NCT07713966

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

— Наблюдательное Hemorrhoids

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HDSS and SHS-HD Questionnaires.
Кому может быть актуально
Состояния в реестре: Hemorrhoids. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Translation and Validation of the Hemorrhoid Disease Symptom Score (HDSS) and Short Health Scale for Hemorrhoid Disease (SHS-HD) in Chinese Patients With Hemorrhoids

Обзор

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗