Condition category
Digestive System
Date applied
18/06/2012
Date assigned
06/07/2012
Last edited
19/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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