跳至主要内容
临床试验/NCT07695649
NCT07695649招募中不适用

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

Hospital Son Llatzer1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
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. 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.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

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

结局指标

主要结局

Technical Reproducibility of Surgery

时间窗: 30 postoperative days

Since 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)
  • Total number of postoperative analgesics(14 postoperative days)
  • Postoperative pain(The first 14 postoperative days)
  • Short Health Scale in hemorrhoidal disease(One year postoperative)
  • Hemorrhoidal disease symptom score(one postoperative year)
  • Hemorrhoidal Clinical Fail Rate(One postoperative year)

研究者

发起方
Hospital Son Llatzer
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignacio Fernandez Hurtado

Principal investigator

Hospital Son Llatzer

研究点 (1)

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