Plain English Summary
Background and study aims
Constipation is common in western societies, affecting women more often than men. Obstructive defecation (OD), an inability to pass stools, may affect up to 12.3% of women. Traditionally Evacuation Proctography (EP) has been used to evaluate the causes of OD. It is an x-ray test that shows the rectum and anal canal as they change during a bowel movement. However, in the last 20 years Magnetic Resonance Defaecography (MRD) has been increasingly studied for the evaluation of OD. MRD is a test that uses radio waves and a strong magnet to obtain high quality images during a bowel movement, avoiding the use of radiation associated with EP. There are only a few small studies comparing EP and MRD with conflicting results. Further studies are therefore needed. The aim of this study is to determine whether MRD or EP provides more useful information for the evaluation of patients with symptoms of OD.
Who can participate?
Patients aged 18 to 90 with symptoms of OD
What does the study involve?
Participants are asked questions about the severity of their symptoms and undergo both EP and MRD in a random order. Based on the results of the first test a hypothetical management plan is made. Once the second test is performed, the consultant surgeon reviews the management plan and any changes are recorded. After both the investigations are complete, participants are given a simple preference questionnaire, which they may return immediately or post at a later date (within 2 weeks).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Heart of England NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2012 to March 2013
Who is funding the study?
Heart of England NHS Foundation Trust (UK)
Who is the main contact?
Mr Michael Feretis
micferetis83@hotmail.co.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Michael Feretis
ORCID ID
Contact details
General surgery Secretaries
Good Hope Hospital
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom
07912118028
micferetis83@hotmail.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2011065GS
Study information
Scientific title
Comparative study of magnetic resonance defaecography and evacuation proctography in evaluation of pelvic floor dysfunction
Acronym
Study hypothesis
There are only a few studies comparing evacuation proctography (EP) and magnetic resonance defecography (MRD) and they are limited by their small sample sizes and conflicting results. Hence further studies are required comparing these two imaging modalities to help inform clinical practice.
Ethics approval
West Midlands Ethics Committee, 07/12/2011, ref:11/WM/0259
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pelvic floor dysfunction/obstructive defecation
Intervention
Patients who consent to take part in the study will undergo both magnetic resonance defaecography and evacuation proctogram. However, the sequence in which these investigations take place will be randomized. Randomization will be done using block randomisation. Imaging requested for study patients will be anonymised. One subspecialist radiologist will report MRD and a second radiologist will report EP, both blinded to clinical findings and reports/images of the other imaging modality. Study patients who fail to evacuate or have suboptimal imaging for various reasons will be recalled for a further attempt at the discretion of the Radiologist or pelvic floor multi-disciplinary team in accordance with standard clinical practice. However, results of the first attempt at imaging only will be included for research data collection purposes. This is because failure to evacuate is one of the outcome measures.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Comparison of proportions and grade of pathology/prolapse in posterior compartment detected by EP and MRD (rectocele, recto-rectal intussusception, perineal descent, enterocele, ability to evacuate).
Secondary outcome measures
1. Comparison of proportion & grade of prolapse in anterior and middle compartment detected by EP and MRD (cystocele, uterine/vaginal vault prolapse)
2. Concordance between findings of EP and MRD
3. Effect on hypothetical management plan by each investigation and if any subsequent change in management after the other investigation
4. Patient preference and acceptability questionnaire
Overall trial start date
30/03/2012
Overall trial end date
30/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >18 and <90
2. Symptoms of obstructive defecation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
57
Participant exclusion criteria
1. Age <18 or >90
2. Patients with previous operations for obstructive defecation
3. Patients with colorectal cancer
4. Mentally incapacitated
5. Patients who do not understand English
6. Patients for whom magnetic resonance imaging is contraindicated (pacemaker, aneurismal clips)
7. Patients with positive pregnancy test
Recruitment start date
30/03/2012
Recruitment end date
30/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Good Hope Hospital
Birmingham
B75 7RR
United Kingdom
Sponsor information
Organisation
Heart of England NHS Foundation Trust (UK)
Sponsor details
Research and Development Directorate
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Heart of England NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list