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临床试验/NCT06851312
NCT06851312已完成不适用

Prospective Observational Study to Assess the Implementation of Minimally Invasive Surgery in the Treatment of Grade III Hemorrhoids: Phase 1 of the IDEAL Framework

Hospital Son Llatzer2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2025年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
2
主要终点
Technical Feasibility 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. Open excisional hemorrhoidectomy (OEH), based on the Milligan-Morgan technique, is the standard procedure. 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. In Stage 1, the first application in humans is documented, analyzing outcomes and feasibility.

Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 1 of the IDEAL model to assess the feasibility of this technique. The investigators believe its incorporation into open 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

入选标准

  • Age over 18 years
  • Grade III hemorrhoids
  • BMI below 30
  • Indication for OEH 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 Hemorrhoids

Patients with symptomatic grade III hemorrhoids who consent to surgical intervention

干预措施: Minimal invasive hemorrhoidectomy (Procedure)

结局指标

主要结局

Technical Feasibility of Surgery

时间窗: From enrollment to the surgical procedure

Since no studies using this approach were found in the literature, the investigators propose a study to assess the feasibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 1. The measurement tool will be the number of patients in whom the technique could be performed

次要结局

  • Adverse events in treated patients(30 postoperative days)

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 (2)

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