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临床试验/NCT03402282
NCT03402282已完成不适用

Upper Rectal Artery Embolization in the Treatment of Hemorrhoidal Disease

Hospital Israelita Albert Einstein2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
short and long upper rectal artery versus surgical repair the classic technique

研究概览

简要总结

Hemorrhoidal disease diagnosis is based on medical history combined with physical exam and complementary exam. Physical exam should include inspection at exertion, digital rectal exam ,and anoscopy.

The treatment indicated in patients with hemorrhoidal disease varies according to the disease grade, and it may be clinical or surgical. The classic surgical approach is an open surgical correction , a technique that has high success rates and low recurrence rates; however, it is accompanied by intense pain.

Based on the concept that hemorrhoids are formed by pathological changes in submucosal pads vascularization in anal channel transition zone, selective embolization of upper rectal artery branches were performed in 14 patients with long-term severe rectal bleeding secondary to hemorrhoidal disease by Vidal et al. with no pain or ischemic symptoms being seen.

  • Main Objective To determine the feasibility of implementing upper rectal artery embolization in the treatment of patients with grade 2 (protrude beyond the anal verge with straining or defecating but reduce spontaneously) and 3 hemorrhoids (protrude spontaneously or with straining and require manual reduction), relating its short- and long-term outcomes with patients undergoing surgical repair through the classic technique
  • Hypothesis The expectation is that, with upper rectal artery embolization, patients experience a decrease or remission of symptoms, such as bleeding, pain and symptoms related to hemorrhoidal pads edema. Another expectation is that the decrease in the number of days to return to daily activities

详细描述

Proposal description 1.1. Hemorrhoids: Epidemiology, Clinical Presentation and Diagnostic Assessment: In the normal anal channel, there are three highly-vascularized areas (pads), forming slight masses in the submucosa made of blood vessels, smooth muscle and elastic and connective tissue, and are located at the left lateral, right anterior and right posterior quadrants, and contribute in anal continence . The term hemorrhoids refers to clinical situations where these hypervascularized pads are abnormal and cause clinical symptoms.

The exact disease prevalence of symptomatic hemorrhoidal disease is difficult to establish, since many symptomatic patients do not seek an assessment, while others assign varied anorectal symptoms as being resulting from hemorrhoids. Some series estimate prevalence between 4 and 40 %. Although many patients will exhibit symptomatic hemorrhoids along life, the peak incidence occurs between 45 and 65 years old and its development prior to 20 years old is rarely frequent . Among the factors related to a higher risk of developing the disease are: pregnancy, white race, females.

Hemorrhoids may be divided as external and internal. External hemorrhoids are covered by anoderm (richly enervated layer), are located distally to the dentate line and their main symptoms are edema, causing discomfort and difficult local hygiene, which may also exhibit an intense pain when thrombosed. Internal hemorrhoids are located proximally to the dentate line and are lined with poorly enervated anorectal mucosa, and rarely cause pain, except when thrombosed and combined with prolapse and necrosis; often their symptoms are prolapse and bleeding.

Internal hemorrhoids may be subdivided into 4 grades: grade 1 are defined by a protuberance in anal channel and may show prolapse beyond the dentate line at great exertion; grade 2 are hemorrhoids prolapsing beyond the dentate line at exertion, but reduced spontaneously; grade 3 are hemorrhoids prolapsing beyond the dentate line, requiring manual reduction; and grade 4 are defined by non-reducing prolapsed hemorrhoids, being at risk of strangulation.

Hemorrhoidal disease diagnosis is based on medical history combined with physical exam and complementary exam. Physical exam should include inspection at exertion, digital rectal exam (which allows an assessment of internal and external hemorrhoids, anal channel tonus assessment, in addition to excluding other diseases, such as neoplasm and sphincter spasm) and anoscopy. Among complementary tests, flexible rectal sigmoidoscopy, colonoscopy, barium enema may be requested at complementary diagnosis, mainly to rule out other diseases.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients aged above 18 years old, with internal and/or external hemorrhoids experiencing clinical symptoms (anemia, persistent / recurrent bleeding hemorrhoidal source> 3 months, episodes of recurrent hemorrhoidal thrombosis (> 2 episodes) or associated the symptoms of hemorrhoidal disease) with surgical indication and contraindication of band ligation and / or photocoagulation infrared accepting the items pointed in the informed consent form.

排除标准

  • Patients with contraindications for angiogram performance (allergy to intravenous contrast), patients with aortic atherosclerosis (femoral pulse and difference Doppler angiography or with stenosis 20%) patients in the daily use of NSAIDs or weak opioids or who refuse to take part in this project will be excluded from this study.

结局指标

主要结局

short and long upper rectal artery versus surgical repair the classic technique

时间窗: 1.5 years

To determine the feasibility of implementing upper rectal artery embolization in the treatment of patients with grade 2 (protrude beyond the anal verge with straining or defecating but reduce spontaneously) and 3 hemorrhoids (protrude spontaneously or with straining and require manual reduction), relating its short- and long-term outcomes with patients undergoing surgical repair through the classic technique (Milligan and Morgan technique).

次要结局

  • Pharmacoeconomic(1.5 years)
  • impact of upper rectal artery embolization on the treatment of hemorrhoidal disease(1.5 years)
  • clinical success of upper rectal artery embolization on the treatment of hemorrhoidal disease.(1.5 years)
  • improves symptoms(1.5 years)
  • clinical recovery(1.5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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