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临床试验/NCT04981600
NCT04981600已完成不适用

LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty Procedure for Grade II-III Hemorrhoidal Disease: Prospective Randomised Controlled Trial

Umraniye Education and Research Hospital4 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
4
主要终点
Change in Visual analog score (VAS) at 4 weeks

研究概览

简要总结

Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. he aim of this study is to compare the two contemporary minimally invasive methods.

详细描述

Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. The indication of treatment depends primarily on the individual burden of the disease rather than its stage. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. Although conventional resection based techniques have less recurrence rates, they tend to have a greater chance of leading to various postoperative complications such as significant postoperative pain, urinary retention, bleeding, abscess formation, anal stenosis, anal fissure and fecal incontinence, deeming non-resection based less invasive techniques more favorable in terms of postoperative morbidity. The main mechanism of non-resection based techniques is creating an inflammatory stimulus inside the prolapsed hemorrhoidal tissue which ultimately causes fibrosis and relocation of the tissue above the dentate line. There are several randomized controlled trials which compared the laser procedure especially with resection based methods in this regard. However, to our knowledge, which is based on a thorough search in the Pubmed and Google Scholar, no randomized clinical trial has been made comparing the radiofrequency ablation method with the laser ablation technique .

The aim of this study is to compare the two contemporary minimally invasive methods in terms of postoperative complications, recovery process and postoperative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic patients who applied to the general surgery outpatient clinic due to stage 2 or 3 hemorrhoidal disease, unresponsive to medical treatment
  • Patients who have not undergone any previous surgery due to hemorrhoidal disease
  • Patients with written informed voluntary consent forms

排除标准

  • Concomitant anorectal disease
  • History of anticoagulant use
  • Fecal incontinence complaint
  • History of active steroid/immunosuppressive use for any reason
  • Pregnancy
  • Inflammatory Bowel Disease

结局指标

主要结局

Change in Visual analog score (VAS) at 4 weeks

时间窗: 1st week and 4th week

Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain.

Rate of Healing

时间窗: 4 month

Hemorrhoid downgrading of at least 1 grade

次要结局

  • Operation Time(Operation 1 Day)
  • Number of admissions(4 months after the procedure)
  • Rate of complications(1st week, 4th week and 4th month)
  • Quality of Life for HSS (Hemorrhoid Severity Score)(1st week and 4th week)
  • Hospitalization Time(Discharge day after the surgery up to 3 days)

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hanife Seyda Ulgur

Assistant Doctor

Umraniye Education and Research Hospital

研究点 (4)

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