MEDAL

Full title: MRI to Establish Diagnosis Against Laparoscopy 

Acronym: MEDAL

Research Funder: NIHR HTA Funder Ref:   09/22/50

Sponsor Ref:   007936 QM

ISRCTN Ref No.:   ISRCTN13028601

REC Ref:   11/EM/0281

UKCRN Project Ref No:   11535

University of Birmingham Ethics Ref: ERN_11-0873

NHS Research Scotland Ref:  NRS12-GY09

Research status: 

OVERVIEW

In 'MEDAL'

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? 

STAFF

Investigators

Chief investigator:

Professor Khalid Khan (This email address is being protected from spambots. You need JavaScript enabled to view it.)
www.birmingham.ac.uk/medal

Trial Co-ordinator:

Lee Priest (This email address is being protected from spambots. You need JavaScript enabled to view it.), 

Clinical Research Fellow:

Anushka Tirlapur (This email address is being protected from spambots. You need JavaScript enabled to view it.),

OTHER INFORMATION

Scientific Summary

Aim

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 aims:

  1. To compare the diagnostic accuracy of the post-MRI diagnoses and the post-laparoscopy diagnoses for 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/initial examination/ultrasound) 
  3. 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

Method

MEDAL is a multicentre prospective cohort study and involves 25 centres nationally. MEDAL aims to recruits 250 patients (December 2011 – September 2013) and is funded NIHR HTA.

Participating London sites

The Royal London (Miss Elizabeth Ball), Whipps Cross (Mr Funlayo Odejinmi), Newham (Mr Antonios Antoniou), Homerton (Miss Sandra Watson), Chelsea and Westminster (Mr Robert Richardson), Southend (Mr Winston Justin).