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Набор скоро начнётся NCT07534761

Minimaly Ivnasive Surgery for Grade III Hemorrhoids

— Наблюдательное Hemorrhoidectomy Minimally Invasive Surgical Technique

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: Minimally Invasive hemorrhoidectomy.
Кому может быть актуально
Состояния в реестре: Hemorrhoidectomy, Minimally Invasive Surgical Technique. 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
Испания
Следующий шаг
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Официальное название

Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework

Обзор

Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Closed excisional hemorrhoidectomy (CEH), based on the Ferguson technique, is one of the standard procedures. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies. Since no previous studies on the application of MIS in CEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into closed excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

Вмешательства

  • Процедура Minimally Invasive hemorrhoidectomy
    The investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

Первичные конечные точки

  • Technical Reproducibility of Surgery [Срок оценки: 30 postoperative days]
Вторичные конечные точки (6)
  • Adverse events in treated patients [Срок оценки: 30 postoperative days]
  • Postoperative pain [Срок оценки: The first 14 postoperative days]
  • Hemorrhoidal disease symptom score [Срок оценки: one postoperative year]
  • Short Health Scale in hemorrhoidal disease [Срок оценки: One year postoperative]
  • Total number of postoperative analgesics [Срок оценки: 14 postoperative days]
  • Clinical Failure Rate [Срок оценки: one year postoperative]

Критерии участия

Критерии включения

  • Age over 18 years
  • Grade III/IV hemorrhoids
  • Indication for CEH surgery
  • Signed written informed consent

Критерии исключения

  • Acute hemorrhoidal disease (thrombosis)
  • Previous hemorrhoid surgery
  • Coexistence of anal fissure
  • Coexistence of perianal fistula
  • Coexistence of rectal or anal prolapse
  • Active inflammatory bowel disease
  • Active anal or colorectal cancer
  • Language barrier or difficulty in oral and/or written comprehension

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Испания · 1 центр
  • Hospital Son Llatzer — Palma

Идентификаторы

NCT: NCT07534761 · HEM CLOSE IDEAL 2A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗