Condition category
Signs and Symptoms
Date applied
16/02/2012
Date assigned
20/02/2012
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic pelvic pain (CPP) is defined as pain in the pelvic and lower abdominal area that lasts six months or longer. In primary care, the proportion of people per year with CPP is 38/1000 in women aged 15-73, a rate similar to that of asthma (37/1000) and chronic back pain (41/1000). There is no effective way to manage CPP. Only 20-25% of patients respond to conservative treatment (that is, treatment that avoids extreme drug therapy or operations). CPP is still the single most common reason for referral to a gynaecology clinic, accounting for 20% of all outpatient appointments. Five percent of all new gynaecological appointments are for CPP. At present there is great variation in clinical practice for diagnosis and management of CPP. There are many cases of CPP in both primary and secondary care. Patients often see several health professionals before their underlying condition is identified. This wastes both the patients' time and NHS resources. A diagnosis of CPP of unknown origin is given if a cause for the pain can't be found. That does not mean that CPP of unknown origin is in the mind; also, severity of pain may not be related to severity of underlying disease, as seen in endometriosis where stage of disease is poorly related to reported pain. In a group of 487 women recruited into a trial of neuroablation (surgery that blocks nerve tissue), 54% of women had no identifiable disease at laparoscopy (keyhole surgery), whilst 31% had endometriosis, 5% had pelvic inflammatory disease and 17% had adhesions. Around 11% had more than one finding. The aim of this study is to find out if magnetic resonance imaging (MRI) can replace laparoscopy in women who have CPP or help to prioritise treatment based on need. We will look at the proportion of women for whom MRI is accurate enough to replace laparoscopy following evaluation of their symptoms. We hope to find out if the 'post-laparoscopy diagnoses' are better for the patient than 'post-MRI diagnoses' (i.e. whether it has helped to find many more disease-related conditions) or whether laparoscopy could have been avoided.

The objectives of the study are:
1. To compare the accuracy of the post-MRI diagnoses and the post-laparoscopy diagnoses for a) the absence of any disease-related cause and b) the main diseases causing CPP.
2. To find out if laparoscopy is more useful than MRI and whether both tests are more useful than information collected at the start of the study (medical history/clinical examination/ultrasound).
3. To find out how much impact MRI and laparoscopy have on diagnostic decision-making, and to compare how good post-MRI diagnoses and the post-laparoscopy diagnoses are.
4. Estimate the number of women who should have a diagnostic laparoscopy or laparoscopy as a treatment.
5. To find out, using mathematical techniques, the symptoms that show which women would benefit most from MRI and which women would not benefit.
6. To create a decision-making model to work out the cost-effectiveness of MRI in reducing the need for laparoscopy.

Who can participate?
You can take part in this study if you are a woman aged 16 and over who has been referred to a gynaecologist with CPP and who has given written informed consent, where the need for a laparoscopy is established and you wish to proceed with it.

What does the study involve?
You will have MRI before laparoscopy but the report will not be given to the gynaecologist, unless there is a critical finding such as possible cancer cells which might spread, so the results do not affect how your treatment would have proceeded. A diagnostic laparoscopy will also be carried out and together with information from your medical history, examination and ultrasound, produce a post-laparoscopy diagnosis. Follow-up at six months, which will look at response to treatment and results of additional tests will also be obtained, and will be used by a panel of experts according to a previously agreed step-by-step procedure to decide the reference diagnosis.

What are the possible benefits and risks of participating?
Risks of MRI are rare, but this test can theoretically produce heat, which is absorbed by the body tissue, but this is not known to produce any side effects. A laparoscopy involves minimal damage to body tissues and is, on the whole, safer than 'open' operations such as laparotomy. Possible complications of laparoscopies include damage to organs inside the abdomen and wound infections. Women having a laparoscopy will need a general anaesthetic and, as with all anaesthetics, there is a risk of complications, particularly in obese women. These risks are extremely small, as we will only allow experienced surgeons/radiologists to take part. By having an additional MRI scan before the laparoscopy, any abnormalities such as cancer cells are highly likely to be found. These may be picked up during the laparoscopy, but if found earlier (in the MRI), treatment can be started before the laparoscopy is carried out.

Where is the study run from?
The study sponsor is Queen Mary University of London (UK) and the coordinating centre is Birmingham Clinical Trials Unit, University of Birmingham (UK).

When is the study starting and how long is it expected to run for?
The study started recruitment in December 2011 and ended in September 2013. The study will run until June 2015.

Who is funding the study?
National Institute for Health Research - Health Technology Assessment (NIHR HTA) (UK).

Who is the main contact?
Mr Lee Priest
l.priest.1@bham.ac.uk

Trial website

http://www.birmingham.ac.uk/medal

Contact information

Type

Scientific

Primary contact

Prof Khalid Khan

ORCID ID

Contact details

Centre for Primary Care and Public Heath
Barts and the London School of Medicine and Dentistry
Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom
+44 (0)20 7882 2621
k.s.khan@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/22/50

Study information

Scientific title

Can magnetic resonance imaging scan replace or triage the use of laparoscopy in establishing a diagnosis amongst women presenting in secondary care with chronic pelvic pain?

Acronym

MEDAL

Study hypothesis

MRI may be a useful diagnostic tool for adenomyosis, deep infiltrating endometriosis and ovarian endometriomas. However, its use for the differential diagnosis of other pathological causes of chronic pelvic pain (CPP) has not yet been fully investigated. Existing research does not tell us whether MRI can replace laparoscopy in the differential diagnosis of underlying conditions. Compared to laparoscopy, MRI may be more or equally accurate, is less invasive, carries fewer risks, is easier to do, does not require a general anaesthetic, is less uncomfortable for patients, has shorter waiting times and is cheaper. MRI findings may also assist in patient management for example referral could be to a gynaecologist specialising in the particular problem discovered, rather than a general gynaecologist.

This study will delineate the accuracy of MRI against a reference diagnosis derived from an expert independent panel and examine the cost-effectiveness of the alternative pathways to diagnosis.

More details can be found at http://www.hta.ac.uk/project/2400.asp
Protocol can be found at http://www.hta.ac.uk/protocols/200900220050.pdf

On 28/01/2014 the following changes were made to the trial record:
1. The overall trial start date was changed from 09/01/2012 to 09/12/2011.
2. The overall trial end date was changed from 27/09/2013 to 14/10/2014.
3. The target number of participants was changed from 250 to 340.

On 08/09/2014 the overall trial end date was changed from 14/10/2014 to 15/06/2015.

Ethics approval

NRES Committee East Midlands - Nottingham 1, 16/08/2011, REC ref: 11/EM/0281

Study design

Multicentre diagnostic accuracy study with a paired design

Primary study design

Observational

Secondary study design

Other

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

Chronic pelvic pain

Intervention

MRI and laparoscopy compared with reference standard.

Those who are eligible and consent to participation in the diagnostic study will have a MRI scan scheduled before the diagnostic laparoscopy.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess if MRI can replace or triage the need for laparoscopy in women presenting with Chronic Pelvic Pain (CPP). We will determine the proportion of women for whom MRI is sufficiently accurate to replace laparoscopy following evaluation of presenting characteristics. This will be completed by ascertaining if the 'post-laparoscopy diagnoses' has added any clinical benefit to the 'post MRI diagnoses' (i.e. whether it has diagnosed substantially more pathological conditions) or whether it could have been avoided.

Secondary outcome measures

1. To compare the diagnostic accuracy of the post-MRI diagnoses and the post-laparoscopy diagnoses for the absence of any pathological cause (i.e. idiopathic) and the main pathological causes of CPP
2. To determine the added value of laparoscopy over MRI and both tests over information collected at baseline (history/clinical examination/ultrasound)
3. To quantify the impact that MRI and laparoscopy have on diagnostic decision-making, and to compare the certainty of the post-MRI diagnoses and the post-laparoscopy diagnoses
4. Estimate the proportion of women for whom a diagnostic and/or therapeutic laparoscopy is indicated
5. To determine, using multiple logistic regression, the presenting characteristics which identify the subgroups who would benefit most from MRI and conversely, those who would not benefit
6. To perform a decision-analytic model based economic evaluation determining the cost-effectiveness of MRI in reducing the need for laparoscopy

Overall trial start date

09/12/2011

Overall trial end date

15/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 16 and over
2. Women referred to a gynaecologist with CPP
3. Women who have given written informed consent
4. Need for a laparoscopy is established and the patient wishes to proceed with it

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

340

Participant exclusion criteria

1. Women who have had a hysterectomy
2. Women who are pregnant
3. Women unable to give consent through incapacity or inability to speak English and lack of suitable interpreter
4. Women who are considered to definitely require an MRI, based on ultrasound and history
5. Women with an identifiable cause of CPP for which treatment can be initiated

Recruitment start date

09/12/2011

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and the London School of Medicine and Dentistry
London
E1 2AB
United Kingdom

Sponsor information

Organisation

Queen Mary, University of London (UK)

Sponsor details

Barts and the London School of Medicine and Dentistry
Joint Research & Development Office
Lower Ground Floor
Queen Mary's Innovation Centre
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7250
Gerry.Leonard@bartshealth.nhs.uk

Sponsor type

University/education

Website

http://www.bartsandthelondon.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (09/22/50)

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

2013 substudy protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24304546

Publication citations

  1. Substudy protocol

    Tirlapur SA, Priest L, Wojdyla D, Khan KS, , Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol., Reprod Health, 2013, 10, 1, 61, doi: 10.1186/1742-4755-10-61.

Additional files

Editorial Notes