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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03841006
Other study ID # MR defecpgraphy in ODS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2020
Est. completion date July 2023

Study information

Verified date May 2020
Source Assiut University
Contact Alshimaa Abdalkreem, radiology M.S.C
Phone 01064676456
Email modystar411@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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:

1. Straining during at least 25% of defecations,

2. Lumpy or hard stools in at least 25% of defecations,

3. Sensation of incomplete evacuation for at least 25% of defecations,

4. Sensation of ano-rectal obstruction/ blockage for at least 25% of defecations,

5. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor),

6. Fewer than three defecations per week.

2. Loose stools are rarely present without the use of laxatives.

3. Insufficient criteria for irritable bowel syndrome. The same criteria define dys-synergic defecation as inappropriate contraction of the pelvic floor or less than 20% relaxation of basal resting sphincter pressure with adequate propulsive forces during attempted defecation .

On physical examination, the paradoxical contraction of the pelvic floor can be assessed by palpation of the puborectalis muscle while the patient is straining . Perineal descent >3 cm, mucous discharge or mucosal prolapse may also be seen when the patient is asked to strain for stools . However, most clinicians do not rely on palpation and advocate the use of specific tests to diagnose ODS . Electromyography (EMG) of the pelvic floor, the balloon expulsion test (BET), and defecography are the most frequently used tests. Other radiologic methods for the dynamic evaluation of the ODS include magnetic resonance imaging and ultrasonography, each of which has its advantages and limitations.

The development of fast Magnetic Resonance Imaging sequences provides a new alternative to study all pelvic visceral movements in a dynamic fashion. MR defecography has several important advantages over conventional defecography. Its non-ionic nature, multiplanar capacity, dynamic evaluation and good temporal resolution along with its high-resolution soft-tissue contrast makes it an ideal modality in the assessment of ODS patients. Imaging in the mid-sagittal plane allows evaluation of the anal canal, anorectal angle, levator muscle and hiatus and the vaginal disposition as well as their relationship to a consistent electronically designated pubo-coccygeal Line (PCL). Diagnostic parameters for pelvic dys-synergy include an indented impression of the pubococcygeus muscle on the rectum with excessive obtuse anorectal angulation accompanied by very prolonged rectal emptying on T2-weighted MR images.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2023
Est. primary completion date July 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI
dynamic MRI pelvis

Locations

Country Name City State
Egypt AssiutU university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Alshimaa Abdalkreem

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Sákra L, Šiller J. [Obstructed defecation syndrome - review article]. Rozhl Chir. Summer 2017;96(6):247-251. Review. Czech. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 :
Normal functional movements of the pelvic floor using pupococygeal line (PCL) as reference line, The anorectal angle (ARA) and Levator plate angle.
Pelvic floor relaxation: using H and M lines
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.
Baseline