Oxford University Hospitals Foundation Trust
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
Location contact
Christian Becker, MD
CONTACT
Katy Vincent, DPhil, FRCOG
CONTACT
Katy Vincent, DPhil, FRCOG
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07313345
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.
Interested in participating?
Request Info18 year–50 year
Female
Observational
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
Christian Becker, MD
CONTACT
Katy Vincent, DPhil, FRCOG
CONTACT
Katy Vincent, DPhil, FRCOG
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: prior to surgery
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.
Time frame: prior to surgery
Resting state connectivity measured with fMRI
Time frame: prior to surgery
Brain volume measured with MRI
Time frame: prior to surgery and at 12 months post-surgery
NRS anchored with 0=no pain, 10=worst pain imaginable
Time frame: Prior to surgery
Measured with the Michigan Body Map. The higher the score the more widespread the pain.
Time frame: prior to surgery
Measured with the painDETECT scale. Scores range from -1 to 38. Higher scores represent more likely to have a neuropathic component to pain.
Time frame: Prior to surgery
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.
Time frame: Prior to surgery
Measured with the pain self-efficacy scale. Scores range from 0 to 60, with higher scores indicating greater confidence in managing pain.
Time frame: Prior to surgery
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
Time frame: Prior to surgery
Individual measures and the overall sensory profile cluster (derived according to Vollert)
Contact information is provided by the study sponsor or research team.
Katy Vincent, DPhil, FRCOG
CONTACT
00 44 1865 220024 ext. 01865220024
Kirralise Hansford, PhD
CONTACT
University of Oxford
Other
Acronym: PrePOSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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