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?
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:
- To compare the diagnostic accuracy of the post-MRI diagnoses and the post-laparoscopy diagnoses for the main pathological causes of CPP
- To determine the added value of laparoscopy over MRI and both tests over information collected at baseline (history/initial examination/ultrasound)
- To compare the certainty of the post-MRI diagnoses and the post-laparoscopy diagnoses
- Estimate the proportion of women for whom a diagnostic and/or therapeutic laparoscopy is indicated
- 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
- To perform a decision-analytic model based economic evaluation determining the cost-effectiveness of MRI in reducing the need for laparoscopy
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
Sponsor: Queen Mary University of London
Chief Investigator: Prof Khalid Khan, Queen Mary University of London
Coordinating Centre: Birmingham Clinical Trials Unit, University of Birmingham