<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03841006</url>
  </required_header>
  <id_info>
    <org_study_id>MR defecpgraphy in ODS</org_study_id>
    <nct_id>NCT03841006</nct_id>
  </id_info>
  <brief_title>Role of MRI Defecography in Diagnosis of Obstructed Defecation Syndrome</brief_title>
  <official_title>Role of MRI Defecography in Diagnosis of Obstructed Defecation Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alshimaa Abdalkreem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to assess the advantages of dynamic magnetic resonance imaging&#xD;
      defecography to elucidate the underlying anatomic and pathophysiologic background in&#xD;
      obstructed defecation patients to guide physicians in patient management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructed defecation syndrome (ODS) is a term used to describe the whole complex of&#xD;
      mechanical and functional disorders leading to difficult or inadequate rectal emptying.&#xD;
      obstructed defecation syndrome has prevalence rate 3.4 % in general population, In obstructed&#xD;
      defecation feces do reach the rectum, but rectal emptying is extremely difficult. These&#xD;
      patients have a feeling that defecation is blocked. Despite repetitive attempts, complete&#xD;
      evacuation of rectal contents is not possible. The patients may also complain of prolonged&#xD;
      and unsuccessful straining at stools, feelings of incomplete evacuation, digital removal of&#xD;
      feces, and laxative abuse.&#xD;
&#xD;
      Constipation caused by obstructed defecation is of two basic types: functional and&#xD;
      mechanical. The functional type includes anismus (pelvic floor dys-synergy), and descending&#xD;
      perineal syndrome, whereas the mechanical type includes rectocele, enterocele, internal&#xD;
      intussusception and overt rectal prolapse.&#xD;
&#xD;
      All of these conditions represent either a defect of pelvic support or abnormal function of&#xD;
      the pelvic floor musculature. The etiology of ODS is controversial. It is presumed that in&#xD;
      childbearing women damage to the innervation and soft tissues of the pelvis may occur as a&#xD;
      direct consequence of vaginal childbirth. Trauma to the pelvic soft tissues can result in&#xD;
      endopelvic fascial and pelvic support defects. Cumulative nerve damage from stretching of&#xD;
      pelvic floor due to childbirth and activities that cause chronic and repetitive increases in&#xD;
      intra-abdominal pressure such as obesity and chronic cough have been suggested to play a role&#xD;
      in the development of symptomatic defects.&#xD;
&#xD;
      Although patients frequently complain of constipation, symptoms such as fruitless straining&#xD;
      and incomplete evacuation are rather subjective and unreliable. Nevertheless, an&#xD;
      international team of experts included these symptoms in the definition of constipation.This&#xD;
      Rome III guidelines, for a patient to be labeled as suffering from functional constipation,&#xD;
      which also includes obstructed defecation, following criteria should be present for at least&#xD;
      3 months:&#xD;
&#xD;
        1. Must include two or more of the following:&#xD;
&#xD;
             1. Straining during at least 25% of defecations,&#xD;
&#xD;
             2. Lumpy or hard stools in at least 25% of defecations,&#xD;
&#xD;
             3. Sensation of incomplete evacuation for at least 25% of defecations,&#xD;
&#xD;
             4. Sensation of ano-rectal obstruction/ blockage for at least 25% of defecations,&#xD;
&#xD;
             5. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital&#xD;
                evacuation, support of the pelvic floor),&#xD;
&#xD;
             6. Fewer than three defecations per week.&#xD;
&#xD;
        2. Loose stools are rarely present without the use of laxatives.&#xD;
&#xD;
        3. Insufficient criteria for irritable bowel syndrome. The same criteria define&#xD;
           dys-synergic defecation as inappropriate contraction of the pelvic floor or less than&#xD;
           20% relaxation of basal resting sphincter pressure with adequate propulsive forces&#xD;
           during attempted defecation .&#xD;
&#xD;
      On physical examination, the paradoxical contraction of the pelvic floor can be assessed by&#xD;
      palpation of the puborectalis muscle while the patient is straining . Perineal descent &gt;3 cm,&#xD;
      mucous discharge or mucosal prolapse may also be seen when the patient is asked to strain for&#xD;
      stools . However, most clinicians do not rely on palpation and advocate the use of specific&#xD;
      tests to diagnose ODS . Electromyography (EMG) of the pelvic floor, the balloon expulsion&#xD;
      test (BET), and defecography are the most frequently used tests. Other radiologic methods for&#xD;
      the dynamic evaluation of the ODS include magnetic resonance imaging and ultrasonography,&#xD;
      each of which has its advantages and limitations.&#xD;
&#xD;
      The development of fast Magnetic Resonance Imaging sequences provides a new alternative to&#xD;
      study all pelvic visceral movements in a dynamic fashion. MR defecography has several&#xD;
      important advantages over conventional defecography. Its non-ionic nature, multiplanar&#xD;
      capacity, dynamic evaluation and good temporal resolution along with its high-resolution&#xD;
      soft-tissue contrast makes it an ideal modality in the assessment of ODS patients. Imaging in&#xD;
      the mid-sagittal plane allows evaluation of the anal canal, anorectal angle, levator muscle&#xD;
      and hiatus and the vaginal disposition as well as their relationship to a consistent&#xD;
      electronically designated pubo-coccygeal Line (PCL). Diagnostic parameters for pelvic&#xD;
      dys-synergy include an indented impression of the pubococcygeus muscle on the rectum with&#xD;
      excessive obtuse anorectal angulation accompanied by very prolonged rectal emptying on&#xD;
      T2-weighted MR images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">May 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>Baseline</time_frame>
    <description>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.&#xD;
data collected by history using Rome III guidelines.&#xD;
imaging data :&#xD;
Normal functional movements of the pelvic floor using pupococygeal line (PCL) as reference line, The anorectal angle (ARA) and Levator plate angle.&#xD;
Pelvic floor relaxation: using H and M lines&#xD;
Defecographic disorders: Rectocele, Intussusception, Rectal prolapse ,Descending perineal syndrome, Anismus, or spastic pelvic floor syndrome and Enterocele.&#xD;
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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>MRI Defecography, ODS</condition>
  <arm_group>
    <arm_group_label>patient group</arm_group_label>
    <description>symptomatic patient and suspicious to have ODS by history and clinical examination those patient will have MRI defecography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>asymptomatic group</arm_group_label>
    <description>Asymptomatic group not suspicious to have ODS by history or clinical examination they will undergone MRI defecography</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>dynamic MRI pelvis</description>
    <arm_group_label>asymptomatic group</arm_group_label>
    <arm_group_label>patient group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Assiute university hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient group: Those with provisional diagnosis of obstructed defecation disorder&#xD;
             based on: History by using Rome III criteria. and Physical examination.&#xD;
&#xD;
          -  asymptomatic group: will be matched with patients for age and sex.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any general contraindication of MRI in some cases as presence of paramagnetic&#xD;
             substance as pacemakers or in patients with claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gehan Sayed</last_name>
    <role>Study Director</role>
    <affiliation>Egypt.Assiut</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alshimaa Abdalkreem, radiology M.S.C</last_name>
    <phone>01064676456</phone>
    <phone_ext>01004542455</phone_ext>
    <email>modystar411@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gehan Sayed</last_name>
    <phone>01224417605</phone>
    <phone_ext>01061622667</phone_ext>
    <email>Gehanseifeldien@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AssiutU university hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Sakra L, Siller J. [Obstructed defecation syndrome - review article]. Rozhl Chir. 2017 Summer;96(6):247-251. Czech.</citation>
    <PMID>28931290</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Alshimaa Abdalkreem</investigator_full_name>
    <investigator_title>Specialist at radiology department Assiut University hospital</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03841006
org study id: MR defecpgraphy in ODS
nct id: NCT03841006
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Crossover
time perspective: Prospective
measure: 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
time frame: Baseline
description: 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.
arm group label: patient group
description: symptomatic patient and suspicious to have ODS by history and clinical examination those patient will have MRI defecography
arm group label: asymptomatic group
description: Asymptomatic group not suspicious to have ODS by history or clinical examination they will undergone MRI defecography
intervention type: Device
intervention name: MRI
description: dynamic MRI pelvis
arm group label: asymptomatic group
arm group label: patient group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gehan Sayed
role: Study Director
affiliation: Egypt.Assiut
last name: Alshimaa Abdalkreem, radiology M.S.C
phone: 01064676456
phone ext: 01004542455
email: modystar411@yahoo.com
last name: Gehan Sayed
phone: 01224417605
phone ext: 01061622667
email: Gehanseifeldien@yahoo.com
facility: 
status: Recruiting
country: Egypt
citation: Sakra L, Siller J. [Obstructed defecation syndrome - review article]. Rozhl Chir. 2017 Summer;96(6):247-251. Czech.
PMID: 28931290
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Alshimaa Abdalkreem
investigator title: Specialist at radiology department Assiut University hospital