Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids (HemEmbo)
Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.
The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.
A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- University of Colorado Health
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Главный следователь:
- Jonathan Lindquist, MD
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Контакт:
- Alejandra Aguilar, MPH, CCRP, CPH
- Номер телефона: 7208486612
- Электронная почта: alejandra.aguilar@cuanschutz.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male or female, aged >18 years
- Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
- French bleeding score > 5
- Rectal bleeding greater than 3 months
- Colonoscopy within three years, negative for colorectal malignancy
- INR < 1.5
- Platelet count > 150,000/dL
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after intervention
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
- Current use of anticoagulants and/or DAPT
- Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
- Prior surgical or endovascular treatment of hemorrhoids
- Prior endoscopic hemorrhoid artery ligation
- Pregnancy or lactation
- Known severe allergic reactions to iodinated contrast not mitigated by standard prophylaxis
- Bleeding attributable to other anorectal pathology such as anal fissures, anorectal abscess, or fistula
- Inflammatory bowel disease
- Inflammatory vasculitis or connective tissue disease
- Current participation in another clinical trial which may interfere with participation in this study
- Treatment with bevacizumab within 2 months
- Contraindication to surgical management of internal hemorrhoids
- Primary or secondary malignancy involving the abdomen or pelvis which is likely to impact treatment
- Prior pelvic radiation therapy
- Prior diagnosis of portal hypertension
- Major comorbidities expected to impact outcomes or increase patient risk, in the judgement of the enrolling physician
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Rectal Artery Embolization
Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
A minimally invasive procedure in which a doctor uses imaging guidance to place a small catheter into an artery and injects embolization materials to block the blood vessels supplying the hemorrhoids. This reduces blood flow and helps shrink the hemorrhoids. |
|
Активный компаратор: Operative Hemorrhoidectomy
Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
A surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quality of Life Following Treatment
Временное ограничение: Baseline and 1 month after treatment
|
Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life. |
Baseline and 1 month after treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to Return to Work
Временное ограничение: From treatment through return to work or normal activities, up to 6 months after treatment
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Comparison of time to return to work following superior rectal artery embolization and open surgical hemorrhoidectomy. |
From treatment through return to work or normal activities, up to 6 months after treatment
|
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Time to Return to Pre-Intervention Activities
Временное ограничение: From treatment until return to pre-intervention activities, up to 6 months after treatment
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Comparison of time to return to pre-intervention activities following superior rectal artery embolization and open surgical hemorrhoidectomy as measured by selected elements of the adapted VEINES questionnaire. Scores range from 3 to 12, with higher scores indicating less limitation in daily, social, and leisure activities and therefore better functional recovery. Lower scores indicate greater activity limitation and poorer functional recovery. |
From treatment until return to pre-intervention activities, up to 6 months after treatment
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Achievement of French Bleeding Score <2
Временное ограничение: 6 months after treatment
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Comparison of proportion of patients that achieve French Bleeding Scores < 2 following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. For the French Bleeding Score, total scores range from 0 to 9, with lower scores indicating less bleeding and better clinical outcomes, and higher scores indicating more severe hemorrhoidal bleeding and worse clinical outcomes. |
6 months after treatment
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Treatment-Related Adverse Events
Временное ограничение: From treatment through 6 months after treatment
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Comparison of adverse events following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. |
From treatment through 6 months after treatment
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Correlation of Rectal Arterial Anatomy With Clinical Outcomes
Временное ограничение: Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.
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Evaluate number and size of arteries and correlate with observed outcomes. |
Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 25-0192
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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