EndometriosisPrePOSENCT07313345
Predicting the Pain Outcome of Surgery for Endometriosis
An observational study of Endometriosis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study aims to determine whether the investigators can predict who will get benefit in terms of their pain from surgery for more severe forms of endometriosis. The investigators will use brain imaging to explore this, as it allows meaningful results from a smaller sample of people than if questionnaires alone were… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Surgical treatment of endometriosis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2025to Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients on the waiting list for surgery for severe endometriosis at the Oxford University Hospitals NHS Trust
Who may be able to join
- 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)
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- 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
Who cannot join
- pregnant, lactating or planning pregnancy during the course of the study
- contraindication to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kirralise Hansford, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals Foundation Trust
Oxford, Oxfordshire, OX3 9DU
Katy Vincent, DPhil, FRCOG, 0044 1865 220024, katy.vincent@wrh.ox.ac.uk
Christian Becker, MD, christian.becker@wrh.ox.ac.uk
About this study
This study aims to determine whether the investigators can predict who will get benefit in terms of their pain from surgery for more severe forms of endometriosis. The investigators will use brain imaging to explore this, as it allows meaningful results from a smaller sample of people than if questionnaires alone were relied on.
Read the detailed description
Endometriosis is a chronic gynaecological condition that affects around 10% of women of reproductive age. This condition can cause debilitating pain, infertility, and poor quality of life. Endometriosis is a condition where tissue resembling the womb lining is present outside of the womb and is associated with an inflammatory pelvic environment. Symptoms of endometriosis can consist of pain during periods, chronic (non-cyclical) pelvic pain, pain during sex, pain when urinating, pain when defecating, and fatigue. Current treatments for endometriosis consist of hormonal, anti-inflammatory and / or analgesic medications and surgery, which is usually laparoscopic ("key-hole"). However, surgery does not always result in a reduction in pain for patients with endometriosis, therefore, it is important to try and understand which patients are most likely to benefit from surgery for their pain management.
Endometriosis is categorized into 4 stages (I - IV), ranging from small areas of tissue that do not extend deeply (stage I) to deep lesions associated with significant scarring of the pelvis and ovarian cysts (endometriomas). Interestingly, symptoms do not correlate with stage of disease. An NIHR funded clinical trial is currently investigating whether surgical treatment of superficial peritoneal endometriosis is of clinical benefit (ESPriT2) and is expected to report early in 2026 (recruitment and baseline data collection are complete). However, women with more severe forms of the disease are excluded from this trial. Surgery is commonly recommended for those with more extensive disease (stages III and IV), however, the risks of surgery are considerably greater for these patients including risk of bladder and bowel damage (sometimes requiring stoma formation) and a negative impact on future fertility. Therefore it is important to better understand who will benefit from this type of surgery. Rather than performing a full clinical trial, the investigators will use a set of experimental tests that allow pain to be understood in more detail meaning less people need to be included in the study and results will be available sooner.
In the present study, patients with pelvic endometriosis at stage III or IV with planned surgical treatment scheduled will be recruited to the project. Participants taking part will provide data at 5 different time points: Time point 1 will consist of several baseline questionnaires, an experimental sensory assessment, and a brain functional magnetic resonance imaging (fMRI) scan. Time point 2 will be the date of their endometriosis surgery, where a questionnaire will be taken, the surgery will be completed, and several biological samples (e.g. blood and small amounts of pelvic fluid and tissue) will be taken. Time points 3 (3 months post-surgery), 4 (6 months post-surgery), and 5 (12 months post-surgery) will consist of completing online questionnaires. All data collected within this project will be used to investigate pain outcome following endometriosis surgery. This research is funded by NIHR BRC.
- Conditions
- Endometriosis
- Being tested
- Surgical treatment of endometriosis
- Keywords
- pelvic pain, fMRI, PROMs
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of endometriosisProcedure or surgery
This is an observational study and thus the surgery performed is part of standard clinical care. The procedure will be at the discretion of the operating surgeon/endometriosis multi-disciplinary team and may include bowel resection, stoma formation, ureteric stenting/reimplantation, salpingectomy, oophorectomy or hysterectomy in addition to excision/ablation of endometriosis lesions. Information about the surgical procedure will be collected, but no planned surgical procedure will be an exclusion.
| Study group | Role | What they receive |
|---|---|---|
| PrePOSE cohort | Women aged 18 - 50 years, with stage III or IV endometriosis, reporting pelvic pain of ≥4/10 and planned for surgical treatment of their endometriosis Receives: Procedure: Surgical treatment of endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain response to punctate stimulation of the calf
BOLD (Blood oxygen level dependent) response measured with fMRI. Analysis will determine whether BOLD response prior to surgery can predict the pain response (at 12 months post-surgery) to surgical treatment of severe endometriosis.
Measured: prior to surgery
Secondary outcomes (8)
Brain connectivity at rest
Resting state connectivity measured with fMRI
Measured: prior to surgery
Brain volume
Brain volume measured with MRI
Measured: prior to surgery
Non-cyclical pelvic pain measured on an 11 point numerical rating scale (NRS)
NRS anchored with 0=no pain, 10=worst pain imaginable
Measured: prior to surgery and at 12 months post-surgery
Pain widespreadness
Measured with the Michigan Body Map. The higher the score the more widespread the pain.
Measured: Prior to surgery
Neuropathic-like pain
Measured with the painDETECT scale. Scores range from -1 to 38. Higher scores represent more likely to have a neuropathic component to pain.
Measured: prior to surgery
Pain catastrophising
Measured with the pain catastrophising scale (Sullivan). Scores range from 0 - 52 with high scores representing higher levels of pain catastrophising. Although three sub scales exist they will not be assessed for the purposes of these main analyses.
Measured: Prior to surgery
Pain self-efficacy
Measured with the pain self-efficacy scale. Scores range from 0 to 60, with higher scores indicating greater confidence in managing pain.
Measured: Prior to surgery
Expectation of surgical efficacy
Measured on an 8 point verbal rating scale anchored with 0=I do not suffer from this and do not expect that will change, 1=very marked improvement, 2=marked improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=marked worsening, 7=very marked worsening
Measured: Prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Endometriosis UK
- Responsible party
- Sponsor
- Investigators
- Katy Vincent, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313345
- Sponsor's protocol ID
- PrePOSE
- Acronym
- PrePOSE
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once data analysis is complete all data will be deposited in appropriate publicly accessible repositories as required by the funders. No personal data will be included in these datasets.