MRI Defecography, ODSNCT03841006
Role of MRI Defecography in Diagnosis of Obstructed Defecation Syndrome
An observational study of MRI Defecography, ODS, run by Alshimaa Abdalkreem at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MRI Defecography, ODS
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2020to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Assiute university hospital
Who may be able to join
- 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.
Who cannot join
- Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- Must include two or more of the following:
- Straining during at least 25% of defecations,
- Lumpy or hard stools in at least 25% of defecations,
- Sensation of incomplete evacuation for at least 25% of defecations,
- Sensation of ano-rectal obstruction/ blockage for at least 25% of defecations,
- Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor),
- Fewer than three defecations per week.
- Loose stools are rarely present without the use of laxatives.
- 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.
- Conditions
- MRI Defecography, ODS
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
dynamic MRI pelvis
| Study group | Role | What they receive |
|---|---|---|
| patient group | symptomatic patient and suspicious to have ODS by history and clinical examination those patient will have MRI defecography Receives: Device: MRI | |
| asymptomatic group | Asymptomatic group not suspicious to have ODS by history or clinical examination they will undergone MRI defecography Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startMay 2020 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRI Defecography, ODSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alshimaa Abdalkreem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alshimaa Abdalkreem, Assiut University
- Investigators
- Gehan Sayed, Study director, Egypt.Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841006
- Sponsor's protocol ID
- MR defecpgraphy in ODS
- Status last verified
- May 2020
- First submitted
- 3 Feb 2019
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sakra L, Siller J. [Obstructed defecation syndrome - review article]. Rozhl Chir. 2017 Summer;96(6):247-251. Czech.
PubMed 28931290
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI Defecography in Diagnosis of Obstructed Defecation Syndrome
- ClinicalTrials.gov ID
- NCT03841006
- Acronym / sponsor ID
- MR defecpgraphy in ODS
- Conditions
- MRI Defecography, ODS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alshimaa AbdalkreemUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Must include two or more of the following:
- Straining during at least 25% of defecations,
- Lumpy or hard stools in at least 25% of defecations,
- Sensation of incomplete evacuation for at least 25% of defecations,
- Sensation of ano-rectal obstruction/ blockage for at least 25% of defecations,
- Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor),
- Fewer than three defecations per week.
- Loose stools are rarely present without the use of laxatives.
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Device: MRIsymptomatic patient and suspicious to have ODS by history and clinical examination those patient will have MRI defecography |
| asymptomatic group | – | Device: MRIAsymptomatic group not suspicious to have ODS by history or clinical examination they will undergone MRI defecography |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Assiute university hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIdynamic MRI pelvis | Device | asymptomatic group, patient group |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 28931290Sakra L, Siller J. [Obstructed defecation syndrome - review article]. Rozhl Chir. 2017 Summer;96(6):247-251. Czech.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gehan Sayed study director
Egypt.Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRI Defecography, ODS, run by Alshimaa Abdalkreem at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshimaa Abdalkreem, radiology M.S.C (01064676456 ext. 01004542455, modystar411@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.