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Идёт набор NCT06386835

Collagen Paste vs Mucosal Advancement Flap for FIA

Без фазы С лечением Fistula-in-ano

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: Collagen Paste, Mucosal advancement.
Кому может быть актуально
Состояния в реестре: Fistula-in-ano. 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
Гонконг
Следующий шаг
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Официальное название

Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial

Обзор

The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.

Подробное описание

Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients.

Collagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.

Вмешательства

  • Процедура Collagen Paste
    Collagen paste injection
  • Процедура Mucosal advancement
    Mucosal advancement flap

Первичные конечные точки

  • Clinical healing of Fistula-in-ano [Срок оценки: 1 year]
Вторичные конечные точки (5)
  • 30-day morbidity [Срок оценки: 30 days]
  • Quality of life score [Срок оценки: 1 year]
  • Postoperative pain score [Срок оценки: 1 week]
  • Faecal incontinence rate [Срок оценки: 1 year]
  • Hospital readmission rate [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Clinical diagnosis of high cryptoglandular fistula-in-ano.
  • Patients must have undergone a prior EUA to characterise the nature of the fistula.
  • The fistula tract should be ≥ 2 cm in length.
  • Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.
  • Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
  • Patients must be aged ≥ 18 years and able to provide informed consent.
  • Fistulas must be of cryptoglandular aetiology.

Критерии исключения

  • Unable/unwilling to provide informed consent.
  • Contraindication to general anaesthesia or spinal anaesthesia.
  • Low trans-sphincteric fistulas.
  • Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).
  • Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).
  • Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.
  • Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.
  • Cultural or religious objection to the use of pig tissue.
  • Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).
  • Patients with recurrent anal fistulas previously treated with a fistula plug.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 2 центра
  • Department of Surgery, Chinese University of Hong Kong — Shatin
  • Prince of Wlaes Hospital — Shatin

Идентификаторы

NCT: NCT06386835 · CREC2021.724-T

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗