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临床试验/NCT04139876
NCT04139876Unknown不适用

Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms

Holbaek Sygehus2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS).

研究概览

简要总结

This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS).

Secondary endpoints are patient satisfaction with the operation, Health related Quality of Life and effect on anal continence.

详细描述

Background

Hemorrhoids is one of the oldest known medical conditions. Description of hemorrhoids is found as early as 2250 Before Christ (BC) in the code of king Hammurabi in Babylon. Even though first recorded treatment is thought to be found in the "Edwin Smith Papyrus" from 1700 BC as of today the treatment of this benign state is still debated. A wide range of prevalence rates of hemorrhoids have been stated in part because of the varying definition ,but the general consensus is that hemorrhoidal disease is a common anorectal disease affecting the quality of life of millions of people worldwide. Operation for hemorrhoid is one of the most common operations for benign disease in Denmark.

Hemorrhoids arise from the normal vascular structures in the anal canal also referred to as anal cushions or sinusoids as they do not contain muscular cells like arteries or veins. These cushions are typically arranged in three main columns or piles in the anal canal forming an important part of the intricate mechanism of the anal canal preventing incontinence.

Hemorrhoids is a pathologic term describing the symptomatic abnormal downward displacement and enlargement of the anal cushions. The term hemorrhoidal disease is used when the hemorrhoids cause symptoms.

Treatment of hemorrhoidal disease consists of conservative management with lifestyle and diet changes or local treatment, minor surgery and surgical treatment depending on the severity of disease and symptoms. The staging of internal hemorrhoids in four categories by the Goligher classification is the classification that generally forms the basis of the treatment in Denmark.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
  • The patient has a Haemorrhoidal Symptom Score of 4 or more
  • The patient has an American Society of Anaesthesiologists (ASA) score I-II
  • The patient's age is 18-85 years at inclusion
  • The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion

排除标准

  • The patient has had previous operation for haemorrhoids within the last 2 years
  • The patient has had previous operation for anal incontinence
  • The patient has an active anal fistula
  • The patient has an active anal fissure
  • The patient has anal incontinence for solid stools
  • Active immunosuppressive therapy (increased risk of anorectal sepsis)
  • Cirrhosis / portal hypertension
  • Mb Crohn.

结局指标

主要结局

Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS).

时间窗: 1 year postoperatively

The HDSS consists of five items on patient-reported frequency of pain, itching, bleeding, soiling and prolapse. Each symptom graded on a five-point scale (0=never, 1=less than once a month, 2=less than once a week, 3=1-6 days per week, 4=every day / always), giving a total score ranging from 0-20. Zero meaning no symptoms. (See reference).

次要结局

  • Patient satisfaction assessed by a seven grade Likert Scale.(Preoperatively (baseline) and 1 year postoperatively)
  • Fecal continence assessed by the Revised Fecal Incontinence Scale (RFIS).(Preoperatively (baseline) and 1 year postoperatively)
  • Hemorrhoidal affection of the patient's daily life assessed by Short Health Scale adapted to hemorrhoidal disease (SHSHD).(Preoperatively (baseline) and 1 year postoperatively)
  • Anal continence (gas and solids) assessed by the Wexner incontinence scale.(Preoperatively (baseline) and 1 year postoperatively)

研究者

发起方
Holbaek Sygehus
申办方类型
Other
责任方
Principal Investigator
主要研究者

André Heiner dos Santos Campos

MD

Holbaek Sygehus

研究点 (2)

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