Role of MRI Defecography in Diagnosis of Obstructed Defecation Syndrome
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMay 26, 2020
May 1, 2020
2.2 years
February 3, 2019
May 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 : 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.
Baseline
Study Arms (2)
patient group
symptomatic patient and suspicious to have ODS by history and clinical examination those patient will have MRI defecography
asymptomatic group
Asymptomatic group not suspicious to have ODS by history or clinical examination they will undergone MRI defecography
Interventions
Eligibility Criteria
Assiute university hospital
You may qualify if:
- 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.
You may not qualify if:
- Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AssiutU university hospital
Asyut, Egypt
Related Publications (1)
Sakra L, Siller J. [Obstructed defecation syndrome - review article]. Rozhl Chir. 2017 Summer;96(6):247-251. Czech.
PMID: 28931290BACKGROUND
Study Officials
- STUDY DIRECTOR
Gehan Sayed
Egypt.Assiut
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Specialist at radiology department Assiut University hospital
Study Record Dates
First Submitted
February 3, 2019
First Posted
February 15, 2019
Study Start
May 1, 2020
Primary Completion
July 1, 2022
Study Completion
July 1, 2023
Last Updated
May 26, 2020
Record last verified: 2020-05