Chronic pelvic pain Signs and Symptoms Pelvic and perineal pain
Conditions
Interventions
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.
Sponsors
Queen Mary, University of London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess if MRI can replace or triage the need for laparoscopy in women presenting with Chronic Pelvic Pain (CPP). The trialists 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed