Reproducibility of a Minimally Invasive Ferguson-type Hemorrhoidectomy for Grade III Hemorrhoids

Официальное название

Prospective Observational Study to Assess the Reproducibility of Ferguson's Minimally Invasive Hemorrhoidectomy in the Treatment of Grade III Hemorrhoids: Phase 2a of the IDEAL 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. Excisional hemorrhoidectomy is the standard procedure. There are two main options: without wound closure (Milligan-Morgan technique) and with wound closure (Ferguson technique). Both options are effective in the long term and cause severe postoperative pain, although comparative studies between Milligan-Morgan and Ferguson hemorrhoidectomy have shown that the Ferguson technique is associated with less postoperative pain and better early wound healing, while maintaining similar long-term efficacy. 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 scarcely been explored in anal surgery. Its potential advantages include reduced tissue injury and improved healing, although it entails a learning curve and may initially prolong operative time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. IDEAL phase 2a focuses on the optimization and technical definition of a surgical innovation, emphasizing continuous improvement based on real clinical practice and laying the foundation for broader and more rigorous subsequent studies. Since no previous studies on the application of MIS in closed Ferguson hemorrhoidectomy have been identified, the investigators propose a phase 2a IDEAL study to assess the reproducibility of this minimally invasive adaptation. The investigators hypothesize that incorporating MIS into the Ferguson technique could further reduce postoperative pain and accelerate recovery, while preserving the well-established effectiveness of closed hemorrhoidectomy in advanced hemorrhoidal disease.

Вмешательства

• Процедура Minimal invasive closed hemorrhoidectomy
  We propose applying minimally invasive surgery to closed Ferguson excisional hemorrhoidectomy, the most effective technique for treating advanced hemorrhoidal disease. We believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of excisional hemorrhoidectomy. Our hypothesis is based on reduced tissue trauma, the increased precision provided by minimally invasive surgery, and secure tissue closure.

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]
• Total number of postoperative analgesics [Срок оценки: 14 postoperative days]
• Postoperative pain [Срок оценки: The first 14 postoperative days]
• Short Health Scale in hemorrhoidal disease [Срок оценки: One year postoperative]
• Hemorrhoidal disease symptom score [Срок оценки: one postoperative year]
• Hemorrhoidal Clinical Fail Rate [Срок оценки: One postoperative year]

Критерии участия

Критерии включения

• Age over 18 years
• Grade III-IV hemorrhoids
• Indication for excisional hemorrhoidectomy 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

Случай-контроль

Центры проведения

Испания · 1 центр

• Hospital Son Llatzer — Palma de Mallorca

Идентификаторы

NCT: NCT07695649 · HEM IDEAL 2A_FERGUSON

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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