Predicting who will get less pain after endometriosis surgery
Predicting the Pain Outcome of Surgery for Endometriosis
This project will use brain scans and questionnaires to try to see if we can predict which people with severe endometriosis will have less pelvic pain after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT07313345 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with stage III or IV endometriosis who are scheduled for surgical treatment. Participants will undergo preoperative brain imaging (fMRI) and complete standardized patient-reported outcome measures about pain and function, with clinical follow-up after surgery. Investigators will analyze imaging and questionnaire data against post-surgical pain changes to identify patterns that predict who benefits from surgery. The approach uses neuroimaging biomarkers to boost predictive power and may require fewer participants than questionnaire-only methods.
Who should consider this trial
Good fit: Adults aged 18–50 who are female or were born female, have stage III–IV endometriosis confirmed by imaging or prior surgery, report pelvic pain of at least 4/10, plan to undergo surgical treatment, can have an MRI, and can complete English-language questionnaires are the intended participants.
Not a fit: People with milder (stage I–II) endometriosis, those who cannot undergo MRI, are pregnant or planning pregnancy, or who have low baseline pelvic pain are unlikely to be eligible or to gain direct benefit from this study's findings.
Why it matters
Potential benefit: If successful, this could help clinicians predict which patients are likely to experience pain relief from surgery and avoid unnecessary operations.
How similar studies have performed: Prior trials have explored surgical outcomes and some research has linked brain imaging to chronic pain states, but using fMRI specifically to predict who will benefit from surgery for severe endometriosis is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * willing and able to give informed consent * aged between 18 and 50 years of age * female or born female * diagnosed with stage III or IV endometriosis by scan (MRI or USS) or previous surgery * surgical treatment of severe endometriosis planned (surgical procedure at discretion of operating surgeon) * reports pelvic pain of ≥4/10 (measured using a 0 - 10 numerical rating scale asking about the participant's worst pelvic pain associated with their endometriosis) * reasonably fluent in English * in the Investigator's opinion, is able and willing to comply with all study requirements * willing to allow his or her General Practitioner and consultant to be notified of participation in the study Exclusion Criteria: * pregnant, lactating or planning pregnancy during the course of the study * contraindication to MRI
Where this trial is running
Oxford, Oxfordshire
- Oxford University Hospitals Foundation Trust — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Katy Vincent — University of Oxford
- Study coordinator: Katy Vincent, DPhil, FRCOG
- Email: katy.vincent@wrh.ox.ac.uk
- Phone: 00 44 1865 220024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.