Comparative study of magnetic resonance defaecography and evacuation proctography in evaluation of pelvic floor dysfunction

ISRCTN	ISRCTN73466412
DOI	https://doi.org/10.1186/ISRCTN73466412
Secondary identifying numbers	2011065GS

Submission date: 18/06/2012
Registration date: 06/07/2012
Last edited: 28/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Michael Feretis
Scientific

General surgery Secretaries
Good Hope Hospital
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom

Phone	07912118028
Email	micferetis83@hotmail.co.uk

Study information

Study design	Randomised trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparative study of magnetic resonance defaecography and evacuation proctography in evaluation of pelvic floor dysfunction
Study objectives	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(s)	West Midlands Ethics Committee, 07/12/2011, ref:11/WM/0259
Health condition(s) or problem(s) studied	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
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 study start date	30/03/2012
Completion date	30/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	57
Key inclusion criteria	1. Age >18 and <90 2. Symptoms of obstructive defecation
Key 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
Date of first enrolment	30/03/2012
Date of final enrolment	30/03/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Good Hope Hospital

Birmingham
B75 7RR
United Kingdom

Sponsor information

Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Directorate
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom

Website	http://www.heartofengland.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Heart of England NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

28/02/2018: No publications found on PubMed.
19/01/2016: Plain English summary added.
18/12/2015: No publications found on PubMed.