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临床试验/NCT03841006
NCT03841006Unknown不适用

Role of MRI Defecography in Diagnosis of Obstructed Defecation Syndrome

Alshimaa Abdalkreem1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
to diagnose obstructed defecation syndrome and its degree by dynamic MRI study with comparison of imaging data with operative data and or clinical scoring of ODS

研究概览

简要总结

The aim of the study was to assess the advantages of dynamic magnetic resonance imaging defecography to elucidate the underlying anatomic and pathophysiologic background in obstructed defecation patients to guide physicians in patient management.

详细描述

Obstructed defecation syndrome (ODS) is a term used to describe the whole complex of mechanical and functional disorders leading to difficult or inadequate rectal emptying. obstructed defecation syndrome has prevalence rate 3.4 % in general population, In obstructed defecation feces do reach the rectum, but rectal emptying is extremely difficult. These patients have a feeling that defecation is blocked. Despite repetitive attempts, complete evacuation of rectal contents is not possible. The patients may also complain of prolonged and unsuccessful straining at stools, feelings of incomplete evacuation, digital removal of feces, and laxative abuse.

Constipation caused by obstructed defecation is of two basic types: functional and mechanical. The functional type includes anismus (pelvic floor dys-synergy), and descending perineal syndrome, whereas the mechanical type includes rectocele, enterocele, internal intussusception and overt rectal prolapse.

All of these conditions represent either a defect of pelvic support or abnormal function of the pelvic floor musculature. The etiology of ODS is controversial. It is presumed that in childbearing women damage to the innervation and soft tissues of the pelvis may occur as a direct consequence of vaginal childbirth. Trauma to the pelvic soft tissues can result in endopelvic fascial and pelvic support defects. Cumulative nerve damage from stretching of pelvic floor due to childbirth and activities that cause chronic and repetitive increases in intra-abdominal pressure such as obesity and chronic cough have been suggested to play a role in the development of symptomatic defects.

Although patients frequently complain of constipation, symptoms such as fruitless straining and incomplete evacuation are rather subjective and unreliable. Nevertheless, an international team of experts included these symptoms in the definition of constipation.This Rome III guidelines, for a patient to be labeled as suffering from functional constipation, which also includes obstructed defecation, following criteria should be present for at least 3 months:

  1. Must include two or more of the following:

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient group: Those with provisional diagnosis of obstructed defecation disorder based on: History by using Rome III criteria. and Physical examination.
  • asymptomatic group: will be matched with patients for age and sex.

排除标准

  • Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia

结局指标

主要结局

to diagnose obstructed defecation syndrome and its degree by dynamic MRI study with comparison of imaging data with operative data and or clinical scoring of ODS

时间窗: Baseline

sensitivity and specificity of MRI defecography in diagnosis of obstructed defecation syndrome and help physician in patient management by using modified Longo score for obstructed defecation syndrome. * data collected by history using Rome III guidelines. * imaging data : 1. Normal functional movements of the pelvic floor using pupococygeal line (PCL) as reference line, The anorectal angle (ARA) and Levator plate angle. 2. Pelvic floor relaxation: using H and M lines 3. Defecographic disorders: Rectocele, Intussusception, Rectal prolapse ,Descending perineal syndrome, Anismus, or spastic pelvic floor syndrome and Enterocele. the imaging data will be correlated with operative data if patient candidate for operation and with clinical examination and modified Longo score patient no candidate for operation.

次要结局

未报告次要终点

研究者

发起方
Alshimaa Abdalkreem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alshimaa Abdalkreem

Specialist at radiology department Assiut University hospital

Assiut University

研究点 (1)

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