Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
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: Biopsy.
- Кому может быть актуально
- Состояния в реестре: Fecal Incontinence. 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
- Швеция
- 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
SFINX - Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
Обзор
This innovative project aims to investigate structures and morphology of the external anal sphincter (EAS) as well as the impact of sacral neuromodulation (SNM) on the EAS morphology and biochemistry among patients with faecal incontinence (FI). SNM is a well implemented treatment for FI and consist of electrical stimulation of sacral nerve roots to promote continence and may even contribute to total continence. It has shown a positive effects on both short- and long-term. The biologic effect of SNM on EAS is unknown. The aim is to investigate the effect of SNM on EAS morphology, function, and biochemistry to help physicians and researchers to understand the underlying mechanisms of SNM and the anal sphincter complex to further improve and optimize treatment methods for patients with FI. The research project consists of three phases. The first phase includes biopsies from the EAS among patients with no previous history of FI. These patients have been diagnosed with rectal cancer and will undergo surgery with abdominoperineal excision. The second phase includes patients diagnosed with FI and subject for implantation of SNM for treatment of FI. Prior to implantation of SNM all patients will have been examined with 3D endo-anal ultrasound and anorectal manometry as well as answered questionnaires targeting general health, bowel dysfunction and FI. A biopsy of the superficial portion of the EAS is retrieved under local anaesthesia in connection to the test period for implantation of the SNM device. The last phase, phase three, includes 3D endo-anal ultrasound, anorectal manometry, and a second biopsy of the EAS twelve months after implantation with SNM. The histopathological analysis in all the three phases will include general morphology, distribution of cell nuclei, satellite cells, muscle fiber type, neural structures and connective tissue.
Вмешательства
- Другое Biopsy
Biopsies from EAS
Первичные конечные точки
- The effect of sacral neuromodulation on the external anal sphincter muscle among patients with faecal incontinence [Срок оценки: 2 years - The biopsies will be analysed and assessed continuously.]
Критерии участия
Phase 1
Критерии включения
- ≥ 18 years of age
- Male or female
- Diagnosed with rectal cancer and receive treatment with abdominoperineal resection
- Signed an informed consent
Критерии исключения
- Previous diagnosis of FI
- Unable to speak and/or read Swedish to ensure informed consent
- Tumour involving the sphincter complex or is in close connection
Phase 2 and 3
Критерии включения
- Diagnosed with FI and will receive treatment with sacral neuromodulation
- Male or female
- Signed an informed consent
Критерии исключения
- Unable to speak and/or read Swedish to ensure informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швеция · 1 центр
- Umeå University Hospital — Umeå
Идентификаторы
NCT: NCT06763861 · Dnr 2024-04527-01