Идёт набор NCT06175325

Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

Без фазы С лечением 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: Trans-radial embolisation of haemorrhoids.
Кому может быть актуально: Состояния в реестре: Hemorrhoids. Базовые параметры: от 18 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: Великобритания
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

Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids

Обзор

Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.

Вмешательства

Процедура Trans-radial embolisation of haemorrhoids
Once patients have provided informed consent to participate, an assessment of symptom severity will be obtained during the initial visit using the a standardised set of 4 validated scoring systems used in research of haemorrhoidal disease. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS). Routine blood tests will be taken. During the procedure, routine observations will be re

Первичные конечные точки

Safety and long-term effects [Срок оценки: 3 years]

Вторичные конечные точки (7)

Change of symptoms [Срок оценки: 3 months]
Change of symptoms [Срок оценки: 12 months]
Change of symptoms [Срок оценки: 24 months]
Cost comparison [Срок оценки: 3 years]
Procedural times comparison [Срок оценки: 3 years]
Radiation dose comparison [Срок оценки: 3 years]
Contrast volume comparison [Срок оценки: 3 years]

Критерии участия

Критерии включения

Patients eligible for the study must comply with all of the following prior to enrolment:

Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
Patients with (i) who do not wish to undergo surgery for their symptoms
Patients with (i) despite recent surgery
Patients willing and able to give fully informed consent
Patients aged ≥18 years