Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Technical Reproducibility of Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Grade III/IV hemorrhoids
- •Indication for CEH surgery
- •Signed written informed consent
排除标准
- •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
研究组 & 干预措施
Grade III / IV hemorrhoids
Patients with symptomatic grade III/IV hemorrhoids who consent to surgical intervention
干预措施: Minimally Invasive hemorrhoidectomy (Procedure)
结局指标
主要结局
Technical Reproducibility of Surgery
时间窗: 30 postoperative days
ince no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications.
次要结局
- Adverse events in treated patients(30 postoperative days)
- Postoperative pain(The first 14 postoperative days)
- Hemorrhoidal disease symptom score(one postoperative year)
- Short Health Scale in hemorrhoidal disease(One year postoperative)
- Total number of postoperative analgesics(14 postoperative days)
- Clinical Failure Rate(one year postoperative)
研究者
Ignacio Fernandez Hurtado
MD
Hospital Son Llatzer
